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Efficacy and Safety of Namilumab (MT203) for Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02129777
Recruitment Status : Completed
First Posted : May 2, 2014
Results First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: Namilumab
Drug: Placebo
Enrollment 122
Recruitment Details Participants were enrolled into the double-blind treatment evaluation at 17 investigative sites in Canada, Denmark, Germany, Latvia, and Poland. Only those sites in Denmark, Latvia and Poland participated in the extension period which included open-label treatment with study medication.
Pre-assignment Details Participants with diagnosis of moderate to severe plaque psoriasis without clinically significant lung/respiratory disorders were screened for enrollment into the study.To fulfill screening requirements,chest X-ray was carried out prior to Baseline visit which included assignment to the double-blind study treatment and first dosing with study drug.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg Open-Label Period: Namilumab 80 mg Open-Label Period: Namilumab 150 mg
Hide Arm/Group Description Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response. Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
Period Title: Double-Blind Period
Started 24 24 24 25 25 0 0
Completed 17 16 20 18 18 0 0
Not Completed 7 8 4 7 7 0 0
Reason Not Completed
Adverse Event             0             0             0             0             1             0             0
Lost to Follow-up             1             1             1             2             0             0             0
Withdrawal by Subject             2             4             3             2             3             0             0
Pregnancy             0             0             0             0             1             0             0
Lack of Efficacy             3             1             0             3             2             0             0
Other             1             2             0             0             0             0             0
Period Title: Open-Label Period
Started 0 0 0 0 0 12 48
Completed 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 12 48
Reason Not Completed
Lack of Efficacy             0             0             0             0             0             0             5
Lost to Follow-up             0             0             0             0             0             1             1
Withdrawal by Subject             0             0             0             0             0             1             3
Study Termination             0             0             0             0             0             10             39
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg Total
Hide Arm/Group Description Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Total of all reporting groups
Overall Number of Baseline Participants 24 24 24 25 25 122
Hide Baseline Analysis Population Description
Randomized set included all participants randomized in this study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 24 participants 25 participants 25 participants 122 participants
40.8  (15.20) 41.1  (11.28) 42.3  (10.92) 39.0  (12.04) 39.8  (9.62) 40.6  (11.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 24 participants 25 participants 25 participants 122 participants
Female
9
  37.5%
4
  16.7%
5
  20.8%
7
  28.0%
13
  52.0%
38
  31.1%
Male
15
  62.5%
20
  83.3%
19
  79.2%
18
  72.0%
12
  48.0%
84
  68.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 24 participants 25 participants 25 participants 122 participants
Not Hispanic or Latino 10 10 12 12 12 56
Unknown or Not Reported 14 14 12 13 13 66
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 24 participants 25 participants 25 participants 122 participants
Asian 2 1 2 2 4 11
Black or African American 0 0 1 0 0 1
Native Hawaiian or Other Pacific Islander 0 1 0 0 0 1
White 22 22 21 23 21 109
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 24 participants 25 participants 25 participants 122 participants
Canada 10 10 12 12 12 56
Denmark 0 1 0 0 1 2
Germany 0 0 0 0 1 1
Latvia 5 5 2 3 2 17
Poland 9 8 10 10 9 46
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 24 participants 24 participants 24 participants 25 participants 25 participants 122 participants
172.3  (10.83) 176.1  (7.73) 176.5  (7.81) 176.8  (8.59) 168.1  (10.28) 173.9  (9.61)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 24 participants 24 participants 24 participants 25 participants 25 participants 122 participants
87.46  (22.864) 88.26  (22.033) 97.84  (33.643) 95.50  (25.056) 82.32  (24.634) 90.25  (26.156)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 24 participants 24 participants 24 participants 25 participants 25 participants 122 participants
29.16  (6.112) 28.25  (5.936) 31.26  (9.532) 30.53  (7.641) 29.01  (8.093) 29.64  (7.539)
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 24 participants 25 participants 25 participants 122 participants
Never Smoked 7 11 9 13 12 52
Current Smoker 8 5 9 7 5 34
Ex-Smoker 9 8 6 5 8 36
1.Primary Outcome
Title Percentage of Participants Achieving 75 Percent Reduction From Baseline Psoriasis Area and Severity Index (PASI) Score (PASI75 Response) at Week 12
Hide Description PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 75% reduction in PASI score relative to baseline PASI Score are reported.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 23 21 22 19 20
Measure Type: Number
Unit of Measure: percentage of participants
8.7 9.5 0 5.3 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Cochran-Mantel-Haenszel (CMH) P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.925
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.008
Confidence Interval (2-Sided) 95%
-0.162 to 0.179
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.162
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.087
Confidence Interval (2-Sided) 95%
-0.202 to 0.028
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.671
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.034
Confidence Interval (2-Sided) 95%
-0.187 to 0.118
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.182
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.087
Confidence Interval (2-Sided) 95%
-0.202 to 0.028
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
2.Secondary Outcome
Title Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score (PASI75 Response) at Weeks 2, 4, 6, and 10
Hide Description PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 75% reduction in PASI score relative to baseline PASI Score are reported.
Time Frame Weeks 2, 4, 6 and 10
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 24 24 24 25 25
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n= 24, 24, 24, 25, 25) 0 0 0 0 0
Week 4 (n= 24, 24, 23, 24, 24) 0 0 4.3 0 0
Week 6 (n= 23, 23, 24, 24, 23) 4.3 8.7 4.2 4.2 0
Week 10 (n= 22, 22, 24, 24, 22) 9.1 4.5 0 4.2 0
3.Secondary Outcome
Title Change From Baseline in PASI Score at Weeks 2, 4, 6, 10, and 12
Hide Description PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease.
Time Frame Baseline, Weeks 2, 4, 6, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 24 24 24 25 25
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline (n=24, 24, 24, 25, 25) 18.6  (1.65) 19.1  (1.57) 20.9  (1.62) 17.4  (1.57) 17.3  (1.52)
Change at Week 2 (n=24, 24, 24, 25, 25) -2.2  (0.70) -1.7  (0.67) -1.2  (0.69) -2.1  (0.67) -1.4  (0.65)
Change at Week 4 (n=24, 24, 23, 24, 24) -3.6  (0.92) -2.8  (0.90) -1.9  (0.92) -2.4  (0.90) -2.2  (0.89)
Change at Week 6 (n=23, 23, 24, 24, 23) -5.1  (1.13) -3.6  (1.10) -1.4  (1.11) -2.4  (1.10) -2.4  (1.10)
Change at Week 10 (n=22, 22, 24, 24, 22) -6.4  (1.30) -4.6  (1.29) -3.2  (1.28) -3.2  (1.27) -3.0  (1.28)
Change at Week 12 (n=23, 21, 22, 19, 20) -6.3  (1.27) -4.9  (1.26) -4.4  (1.25) -3.3  (1.26) -3.4  (1.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.435
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-2.1 to 4.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.75
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.279
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-1.6 to 5.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.74
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-0.4 to 6.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.74
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
-0.7 to 6.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.76
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
4.Secondary Outcome
Title Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score (PASI50 Response) at Weeks 2, 4, 6, 10 and 12
Hide Description PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 50% reduction in PASI score relative to baseline PASI Score are reported.
Time Frame Weeks 2, 4, 6, 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 24 24 24 25 25
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n= 24, 24, 24, 25, 25) 4.2 0 0 0 0
Week 4 (n= 24, 24, 23, 24, 24) 8.3 4.2 8.7 4.2 0
Week 6 (n= 23, 23, 24, 24, 23) 13.0 13.0 8.3 4.2 4.3
Week 10 (n= 22, 22, 24, 24, 22) 22.7 18.2 12.5 8.3 9.1
Week 12 (n= 23, 21, 22, 19, 20) 21.7 19.0 18.2 10.5 20.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.827
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.027
Confidence Interval (2-Sided) 95%
-0.265 to 0.211
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.768
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.036
Confidence Interval (2-Sided) 95%
-0.269 to 0.198
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.338
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.112
Confidence Interval (2-Sided) 95%
-0.330 to 0.106
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.890
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.017
Confidence Interval (2-Sided) 95%
-0.261 to 0.226
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
5.Secondary Outcome
Title Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score (PASI90 Response) at Weeks 2, 4, 6, 10 and 12
Hide Description PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 90% reduction in PASI score relative to baseline PASI Score are reported.
Time Frame Weeks 2, 4, 6, 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 24 24 24 25 25
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n= 24, 24, 24, 25, 25) 0 0 0 0 0
Week 4 (n= 24, 24, 23, 24, 24) 0 0 0 0 0
Week 6 (n= 23, 23, 24, 24, 23) 0 4.3 0 0 0
Week 10 (n= 22, 22, 24, 24, 22) 0 4.5 0 0 0
Week 12 (n= 23, 21, 22, 19, 20) 0 4.8 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Week 12:CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.295
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.048
Confidence Interval (2-Sided) 95%
-0.043 to 0.139
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
6.Secondary Outcome
Title Percentage of Participants Achieving Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Static Physicians Global Assessment (sPGA) Score at Weeks 2, 4, 6, 10 and 12
Hide Description sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). Participants who had >=2 point improvement are reported.
Time Frame Weeks 2, 4, 6, 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 24 24 24 25 25
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n= 24, 24, 24, 25, 25) 0 0 0 0 0
Week 4 (n= 24, 24, 23, 24, 24) 0 4.2 4.3 0 0
Week 6 (n= 23, 23, 24, 24, 23) 0 13.0 4.2 0 0
Week 10 (n= 22, 22, 24, 24, 22) 13.6 4.5 4.2 0 4.5
Week 12 (n= 23, 21, 22, 19, 20) 13.0 14.3 9.1 0 5.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.906
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.012
Confidence Interval (2-Sided) 95%
-0.191 to 0.216
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.677
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.040
Confidence Interval (2-Sided) 95%
-0.222 to 0.143
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.130
Confidence Interval (2-Sided) 95%
-0.268 to 0.007
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.371
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.080
Confidence Interval (2-Sided) 95%
-0.248 to 0.087
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
7.Secondary Outcome
Title Percentage of Participants Achieving a sPGA Response of Clear (0) or Almost Clear (1) at Weeks 2, 4, 6, 10 and 12
Hide Description sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). ‘Clear’ and 'Almost clear’ included all participants who had scored a 0 or 1.
Time Frame Weeks 2, 4, 6, 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 24 24 24 25 25
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n= 24, 24, 24, 25, 25) 0 0 0 0 0
Week 4 (n= 24, 24, 23, 24, 24) 0 0 0 0 0
Week 6 (n= 23, 23, 24, 24, 23) 0 4.3 0 0 0
Week 10 (n= 22, 22, 24, 24, 22) 0 4.5 0 0 0
Week 12 (n= 23, 21, 22, 19, 20) 0 9.5 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.095
Confidence Interval (2-Sided) 95%
-0.030 to 0.221
Estimation Comments Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
8.Secondary Outcome
Title Change From Baseline in sPGA Score at Weeks 2, 4, 6, 10, and 12
Hide Description sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe).
Time Frame Baseline, Weeks 2, 4, 6, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 24 24 24 25 25
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline (n=24, 24, 24, 25, 25) 3.5  (0.11) 3.5  (0.11) 3.6  (0.11) 3.3  (0.11) 3.6  (0.10)
Change at Week 2 (n=24, 24, 24, 25, 25) -0.1  (0.08) -0.1  (0.08) -0.2  (0.08) -0.1  (0.08) -0.1  (0.08)
Change at Week 4 (n=24, 24, 23, 24, 24) -0.1  (0.10) -0.3  (0.10) -0.2  (0.10) -0.2  (0.10) -0.3  (0.09)
Change at Week 6 (n=23, 23, 24, 24, 23) -0.3  (0.12) -0.5  (0.12) -0.3  (0.12) -0.2  (0.12) -0.2  (0.12)
Change at Week 10 (n=22, 22, 24, 24, 22) -0.4  (0.12) -0.5  (0.12) -0.4  (0.12) -0.3  (0.12) -0.5  (0.12)
Change at Week 12 (n=23, 21, 22, 19, 20) -0.4  (0.13) -0.6  (0.13) -0.6  (0.13) -0.4  (0.13) -0.5  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an analysis of variance (ANOVA) model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.258
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.6 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.18
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.365
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.5 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.18
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.757
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.18
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.825
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.4 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.18
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
9.Secondary Outcome
Title Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 6, 10, and 12
Hide Description Assessment of BSA with psoriasis was performed by means of the palm method, where the palm of the participant’s hand represented 1% of BSA. The affected areas were then calculated by their size compared to the participant’s palm.
Time Frame Baseline, Weeks 2, 4, 6, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 24 24 24 25 25
Least Squares Mean (Standard Error)
Unit of Measure: percentage of total body surface area
Baseline (n=24, 24, 24, 25, 25) 23.09  (3.674) 24.39  (3.485) 26.16  (3.596) 22.35  (3.497) 21.84  (3.385)
Change at Week 2 (n=24, 24, 24, 25, 25) -0.59  (0.624) -0.22  (0.591) 0.21  (0.610) -0.35  (0.594) -0.26  (0.576)
Change at Week 4 (n=24, 24, 23, 24, 24) -0.86  (0.945) -1.02  (0.923) -0.24  (0.940) -0.09  (0.923) 0.25  (0.911)
Change at Week 6 (n=23, 23, 24, 24, 23) -1.78  (1.366) -3.65  (1.351) 0.43  (1.349) 0.36  (1.340) 0.12  (1.343)
Change at Week 10 (n=22, 22, 24, 24, 22) -3.24  (1.551) -4.55  (1.542) -0.63  (1.522) 0.45  (1.513) -0.51  (1.535)
Change at Week 12 (n=23, 21, 22, 19, 20) -3.29  (1.537) -3.48  (1.553) -1.70  (1.527) 0.35  (1.559) -0.51  (1.560)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.931
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-4.48 to 4.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.163
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.459
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.59
Confidence Interval (2-Sided) 95%
-2.65 to 5.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.143
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.094
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.65
Confidence Interval (2-Sided) 95%
-0.63 to 7.93
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.161
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.203
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.78
Confidence Interval (2-Sided) 95%
-1.52 to 7.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.173
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
10.Secondary Outcome
Title Change From Baseline in Visual Analogue Scale (VAS) Itching Score at Weeks 2, 4, 6, 10, and 12
Hide Description Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their level of itching by marking a horizontal line with “No itch” at the left extreme and “Worst itch imaginable” at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of itching experienced during the previous 24 hours.
Time Frame Baseline, Weeks 2, 4, 6, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 24 24 24 25 25
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline (n=23, 23, 24, 25, 25) 5.35  (0.633) 5.28  (0.600) 5.67  (0.610) 6.08  (0.593) 5.00  (0.575)
Change at Week 2 (n=23, 23, 23, 25, 24) -1.34  (0.441) -1.15  (0.418) -1.92  (0.427) -1.42  (0.417) -1.36  (0.402)
Change at Week 4 (n=23, 23, 23, 23, 24) -1.38  (0.501) -1.46  (0.480) -2.10  (0.486) -1.66  (0.477) -1.48  (0.462)
Change at Week 6 (n=22, 22, 24, 22, 23) -1.08  (0.502) -1.54  (0.482) -2.01  (0.485) -1.57  (0.479) -1.33  (0.464)
Change at Week 10 (n=21, 21, 24, 22, 21) -1.12  (0.515) -1.47  (0.497) -2.00  (0.496) -1.51  (0.492) -1.68  (0.481)
Change at Week 12 (n=22, 20, 22, 17, 20) -0.95  (0.523) -1.49  (0.508) -2.11  (0.504) -1.54  (0.508) -2.11  (0.494)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-1.92 to 0.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.700
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-2.53 to 0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.692
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.396
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-1.96 to 0.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.690
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-2.54 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.697
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
11.Secondary Outcome
Title Change From Baseline in VAS Joint Pain Score at Weeks 2, 4, 6, 10, and 12
Hide Description Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their severity of joint pain by marking a horizontal line with “No pain” at the left extreme and “Worst pain imaginable” at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of pain experienced during the previous 24 hours.
Time Frame Baseline, Weeks 2, 4, 6, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 24 24 24 25 25
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline (n=23, 23, 24, 25, 25) 1.55  (0.618) 3.45  (0.585) 3.52  (0.595) 3.14  (0.579) 2.13  (0.560)
Change at Week 2 (n=23, 23, 23, 25, 24) -0.25  (0.334) -0.89  (0.316) -0.81  (0.323) -0.68  (0.311) -0.30  (0.301)
Change at Week 4 (n=23, 23, 23, 23, 24) -0.28  (0.378) -1.06  (0.362) -0.91  (0.366) -0.89  (0.356) -0.47  (0.346)
Change at Week 6 (n=22, 21, 24, 22, 23) -0.04  (0.405) -0.84  (0.390) -0.90  (0.391) -0.63  (0.384) -0.47  (0.374)
Change at Week 10 (n=21, 21, 24, 22, 21) -0.08  (0.417) -0.60  (0.402) -0.77  (0.401) -0.56  (0.396) -0.56  (0.387)
Change at Week 12 (n=22, 20, 22, 17, 20) 0.51  (0.458) -0.54  (0.449) -0.75  (0.444) -0.47  (0.452) -0.72  (0.436)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.04
Confidence Interval (2-Sided) 95%
-2.29 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.626
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.26
Confidence Interval (2-Sided) 95%
-2.49 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.619
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.118
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.98
Confidence Interval (2-Sided) 95%
-2.21 to 0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.620
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.22
Confidence Interval (2-Sided) 95%
-2.44 to 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.616
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
12.Secondary Outcome
Title Change From Baseline in VAS Morning Stiffness Score at Weeks 2, 4, 6, 10, and 12
Hide Description Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their level of morning stiffness by marking a horizontal line with “No stiffness” at the left extreme and “Very severe stiffness” at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of stiffness experienced by the participant since waking on that particular day.
Time Frame Baseline, Weeks 2, 4, 6, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 23 24 24 25 25
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline (n=23, 23, 24, 25, 25) 1.73  (0.592) 3.32  (0.561) 3.33  (0.571) 2.77  (0.555) 2.32  (0.537)
Change at Week 2 (n=23, 23, 23, 25, 24) -0.22  (0.276) -0.87  (0.266) -0.91  (0.271) -0.67  (0.259) -0.32  (0.250)
Change at Week 4 (n=23, 23, 23, 23, 24) -0.31  (0.316) -0.95  (0.307) -0.97  (0.310) -0.80  (0.300) -0.26  (0.291)
Change at Week 6 (n=22, 21, 24, 22, 23) -0.27  (0.351) -0.84  (0.343) -0.97  (0.342) -0.61  (0.335) -0.21  (0.327)
Change at Week 10 (n=21, 21, 24, 22, 21) -0.38  (0.372) -0.74  (0.364) -0.94  (0.362) -0.46  (0.356) -0.24  (0.349)
Change at Week 12 (n=22, 20, 22, 17, 20) -0.16  (0.368) -0.79  (0.363) -1.02  (0.359) -0.43  (0.361) -0.24  (0.350)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.211
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-1.63 to 0.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.503
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.86
Confidence Interval (2-Sided) 95%
-1.85 to 0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.497
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.580
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-1.26 to 0.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.494
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.873
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-1.06 to 0.90
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.496
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
13.Secondary Outcome
Title Change From Baseline in Duration of Morning Stiffness at Weeks 2, 4, 6, 10, and 12
Hide Description Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Duration of stiffness was elicited in response to a standard question included in the portable device.
Time Frame Baseline, Weeks 2, 4, 6, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 13 17 17 18 18
Least Squares Mean (Standard Error)
Unit of Measure: minutes
Baseline (n=13, 17, 17, 18, 18) 6.6  (5.65) 14.2  (4.49) 18.2  (4.84) 16.6  (4.58) 12.4  (4.91)
Change at Week 2 (n=13, 16, 17, 17, 17) 1.2  (3.33) -1.7  (2.67) 0.1  (2.85) -5.3  (2.73) -0.2  (2.88)
Change at Week 4 (n=13, 16, 16, 16, 17) -0.9  (3.49) -3.0  (2.80) 2.4  (3.01) -2.8  (2.88) 1.0  (3.03)
Change at Week 6 (n=13, 13, 17, 14, 16) -0.6  (4.06) -2.4  (3.39) 4.1  (3.50) -2.0  (3.44) 1.8  (3.55)
Change at Week 10 (n=11, 15, 17, 15, 13) -0.9  (4.30) -2.3  (3.58) 5.2  (3.71) -2.0  (3.64) 1.3  (3.77)
Change at Week 12 (n=13, 14, 16, 12, 12) -1.4  (5.12) -3.0  (4.35) 6.5  (4.44) -0.6  (4.42) 3.0  (4.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.803
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-15.2 to 11.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.70
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.248
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 7.9
Confidence Interval (2-Sided) 95%
-5.7 to 21.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.73
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.914
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-12.7 to 14.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.67
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.523
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
-9.2 to 17.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.74
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
14.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12
Hide Description The DLQI is a 10-point rating scale for determining the impact of dermatological conditions on the participant’s quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Maximum total score is 30, where 0-1 represents “No effect at all on participant's life” and 21-30 “Extremely large effect on participant's life” - higher scores indicating poorer quality of life.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 21 21 22 19 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 13.8  (1.95) 12.2  (1.85) 10.3  (1.83) 13.9  (1.95) 11.4  (1.89)
Change at Week 12 -0.7  (1.06) -0.7  (1.01) -1.9  (1.01) -2.1  (1.06) -2.8  (1.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Post-baseline least squares means and p-values were from an Analysis of covariance (ANCOVA) model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.978
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-2.7 to 2.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.37
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.389
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-3.9 to 1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.36
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.316
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-4.2 to 1.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.39
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-4.9 to 0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.41
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
15.Secondary Outcome
Title Change From Baseline in Short Form 36 Health Survey (SF-36) at Week 12
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 20 20 22 19 18
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Physical Health Summary Score: Baseline 52.9  (2.08) 46.6  (1.97) 49.0  (1.92) 52.8  (2.04) 50.7  (2.05)
Physical Health Summary Score: Change at Week 12 -0.5  (1.31) -2.6  (1.24) -0.8  (1.19) 0.9  (1.28) 0.4  (1.27)
Mental Health Summary Score: Baseline 43.7  (2.67) 42.9  (2.53) 42.8  (2.46) 42.3  (2.61) 46.0  (2.63)
Mental Health Summary Score: Change at Week 12 0.9  (1.78) 2.8  (1.69) 1.5  (1.64) 1.5  (1.75) 1.6  (1.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.229
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-5.6 to 1.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.73
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.863
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-3.6 to 3.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.65
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.403
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-1.9 to 4.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.67
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.597
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-2.5 to 4.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.74
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.416
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-2.7 to 6.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.32
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.770
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-3.8 to 5.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.24
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.798
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-4.0 to 5.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.31
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.767
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-4.1 to 5.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.40
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
16.Secondary Outcome
Title Change From Baseline in EuroQoL Health Questionnaire (EQ-5D)- Index Score at Week 12
Hide Description EQ-5D-Index score is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The score ranges from -0.594 to 1.000. The higher score indicates a better health state perceived by the participant.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 20 20 22 19 18
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 0.86  (0.041) 0.80  (0.038) 0.84  (0.038) 0.81  (0.040) 0.87  (0.040)
Change at Week 12 -0.02  (0.033) -0.04  (0.031) -0.04  (0.030) 0.01  (0.033) 0.01  (0.033)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.570
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.11 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.043
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.619
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.10 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.042
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.597
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.06 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.043
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.509
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.06 to 0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.044
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
17.Secondary Outcome
Title Change From Baseline in EQ-5D-VAS Score at Week 12
Hide Description EQ-5D-VAS is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (“Worst imaginable health state”) to 100 mm (“Best imaginable health state”); higher scores indicate a better health state.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 16 17 20 17 16
Least Squares Mean (Standard Error)
Unit of Measure: millimeter (mm)
Baseline 76.8  (5.77) 58.9  (5.13) 67.2  (5.09) 75.3  (5.42) 74.3  (5.47)
Change at Week 12 0.5  (3.99) -0.5  (3.67) 5.3  (3.51) -1.4  (3.74) -1.9  (3.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.845
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-11.7 to 9.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.32
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.323
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.8
Confidence Interval (2-Sided) 95%
-4.8 to 14.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.80
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.697
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-11.7 to 7.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.89
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.633
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-12.6 to 7.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.10
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
18.Secondary Outcome
Title Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 6, 10, and 12
Hide Description The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Time Frame Baseline, Weeks 2, 4, 6, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
Hide Arm/Group Description:
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
Overall Number of Participants Analyzed 24 24 24 25 25
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline (n=24, 24, 24, 25, 25) 14.5  (3.56) 9.6  (3.37) 15.6  (3.48) 12.0  (3.39) 12.5  (3.28)
Change at Week 2 (n=24, 24, 24, 25, 25) -0.8  (0.53) 0.1  (0.50) 0.8  (0.52) 0.4  (0.50) 0.1  (0.48)
Change at Week 4 (n=24, 24, 23, 24, 24) -1.5  (0.77) 0.0  (0.75) 1.4  (0.77) 0.6  (0.75) 0.1  (0.74)
Change at Week 6 (n=23, 23, 24, 24, 23) -1.5  (0.99) -0.2  (0.98) 1.2  (0.98) 2.3  (0.97) -0.7  (0.97)
Change at Week 10 (n=22, 22, 24, 24, 21) -2.4  (1.03) -0.6  (1.02) 0.8  (1.01) 2.0  (1.00) 0.6  (1.02)
Change at Week 12 (n=23, 21, 22, 19, 20) -1.5  (1.17) -0.5  (1.18) 0.9  (1.16) 2.5  (1.17) 1.0  (1.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 20 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.537
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-2.2 to 4.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.64
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 50 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-0.8 to 5.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.62
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 80 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.0
Confidence Interval (2-Sided) 95%
0.8 to 7.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.63
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double-Blind Period: Placebo, Double-Blind Period: Namilumab 150 mg
Comments Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.121
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
-0.7 to 5.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.64
Estimation Comments LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
Adverse Event Reporting Description At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg Open-Label Period: Namilumab 80 mg Open-Label Period: Namilumab 150 mg Follow-up Period: Placebo Follow-up Period: Namilumab 20 mg Follow-up Period: Namilumab 50 mg Follow-up Period: Namilumab 80 mg Follow-up: Namilumab 150 mg
Hide Arm/Group Description Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period. Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response. Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response. Participants who received namilumab-matching placebo injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period. Participants who received namilumab 20 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period. Participants who received namilumab 50 mg injections during the double-blind treatment were to be followed-up after the last dose of study drug - whether administered in the double-blind period or open-label extension period. Participants who received namilumab 80 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period. Participants who received namilumab 150 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
All-Cause Mortality
Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg Open-Label Period: Namilumab 80 mg Open-Label Period: Namilumab 150 mg Follow-up Period: Placebo Follow-up Period: Namilumab 20 mg Follow-up Period: Namilumab 50 mg Follow-up Period: Namilumab 80 mg Follow-up: Namilumab 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg Open-Label Period: Namilumab 80 mg Open-Label Period: Namilumab 150 mg Follow-up Period: Placebo Follow-up Period: Namilumab 20 mg Follow-up Period: Namilumab 50 mg Follow-up Period: Namilumab 80 mg Follow-up: Namilumab 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/24 (4.17%)   0/24 (0.00%)   0/24 (0.00%)   0/25 (0.00%)   0/25 (0.00%)   0/12 (0.00%)   0/48 (0.00%)   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
Vascular disorders                         
Hypertensive crisis * 1  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/12 (0.00%)  0/48 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg Open-Label Period: Namilumab 80 mg Open-Label Period: Namilumab 150 mg Follow-up Period: Placebo Follow-up Period: Namilumab 20 mg Follow-up Period: Namilumab 50 mg Follow-up Period: Namilumab 80 mg Follow-up: Namilumab 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/24 (20.83%)   0/24 (0.00%)   2/24 (8.33%)   3/25 (12.00%)   2/25 (8.00%)   4/12 (33.33%)   2/48 (4.17%)   1/24 (4.17%)   0/24 (0.00%)   0/24 (0.00%)   1/25 (4.00%)   1/25 (4.00%) 
Gastrointestinal disorders                         
Toothache * 1  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/12 (8.33%)  0/48 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Infections and infestations                         
Nasopharyngitis * 1  3/24 (12.50%)  0/24 (0.00%)  1/24 (4.17%)  3/25 (12.00%)  1/25 (4.00%)  0/12 (0.00%)  2/48 (4.17%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  1/25 (4.00%)  1/25 (4.00%) 
Upper respiratory tract infection * 1  2/24 (8.33%)  0/24 (0.00%)  1/24 (4.17%)  0/25 (0.00%)  1/25 (4.00%)  1/12 (8.33%)  0/48 (0.00%)  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Injury, poisoning and procedural complications                         
Limb injury * 1  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/12 (8.33%)  0/48 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Wound * 1  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/12 (8.33%)  0/48 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Investigations                         
Blood creatine phosphokinase increased * 1  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/12 (8.33%)  0/48 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Metabolism and nutrition disorders                         
Hypertriglyceridaemia * 1  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/12 (8.33%)  0/48 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02129777     History of Changes
Other Study ID Numbers: M1-1188_203
U1111-1146-1219 ( Other Identifier: WHO )
2013-002806-30 ( EudraCT Number )
172235 ( Registry Identifier: HC-CTD )
First Submitted: April 14, 2014
First Posted: May 2, 2014
Results First Submitted: February 23, 2017
Results First Posted: April 7, 2017
Last Update Posted: April 7, 2017