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A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis (VOYAGE 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02207231
Recruitment Status : Completed
First Posted : August 4, 2014
Results First Posted : October 19, 2017
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Guselkumab 100 mg
Drug: Placebo for guselkumab
Drug: Adalimumab
Drug: Placebo for adalimumab
Enrollment 837
Recruitment Details  
Pre-assignment Details Results are reported through Week 48. Complete data through Week 264 will be reported within 1 year of end of study trial date when final data based on study completion date will be available.
Arm/Group Title Placebo Then Guselkumab 100 mg Guselkumab 100 mg Adalimumab
Hide Arm/Group Description Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP). Participants then crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 and placebo matched to adalimumab subcutaneous injection at Weeks 17, 19, 21, and 23 and every 2 weeks thereafter through Week 47 in the active controlled period (ACP). Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47. Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
Period Title: Placebo Controlled Period: Week 0 - 16
Started 174 329 334
Treated 174 329 333
Completed 167 322 324
Not Completed 7 7 10
Reason Not Completed
Adverse Event             2             4             2
Lack of Efficacy             2             0             1
Lost to Follow-up             1             1             1
Withdrawal by Subject             2             0             4
Protocol Violation             0             0             1
Noncompliance             0             2             1
Period Title: Active Controlled Period: Week 16 - 48
Started 165 [1] 322 324
Completed 162 301 282
Not Completed 3 21 42
Reason Not Completed
Adverse Event             1             6             9
Pregnancy             0             0             1
Lack of Efficacy             0             3             11
Lost to Follow-up             1             2             5
Withdrawal by Subject             1             4             10
Protocol Violation             0             1             0
Other             0             2             3
Non-compliance             0             3             3
[1]
2 participants did not cross-over.
Arm/Group Title Placebo Then Guselkumab 100 mg Guselkumab 100 mg Adalimumab Total
Hide Arm/Group Description Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks through Week 15 in the placebo controlled period (PCP). Participants then crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 and placebo matched to adalimumab subcutaneous injection at Weeks 17, 19, 21, and 23 and every 2 weeks thereafter through Week 47 in the active controlled period (ACP). Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47. Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Total of all reporting groups
Overall Number of Baseline Participants 174 329 334 837
Hide Baseline Analysis Population Description
Randomized analysis set included all participants who were randomized at Week 0.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 329 participants 334 participants 837 participants
<=18 years
0
   0.0%
0
   0.0%
3
   0.9%
3
   0.4%
Between 18 and 65 years
164
  94.3%
311
  94.5%
315
  94.3%
790
  94.4%
>=65 years
10
   5.7%
18
   5.5%
16
   4.8%
44
   5.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 174 participants 329 participants 334 participants 837 participants
44.9  (12.9) 43.9  (12.74) 42.9  (12.58) 43.7  (12.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 329 participants 334 participants 837 participants
Female
55
  31.6%
89
  27.1%
85
  25.4%
229
  27.4%
Male
119
  68.4%
240
  72.9%
249
  74.6%
608
  72.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 174 participants 329 participants 334 participants 837 participants
Australia 13 23 21 57
Taiwan, Province Of China 15 31 27 73
Hungary 7 9 14 30
Poland 22 42 43 107
Russia 21 48 49 118
Canada 24 50 48 122
United States 38 65 67 170
Germany 23 41 43 107
Spain 4 8 13 25
Korea, Democratic People'S Republic Of 7 12 9 28
1.Primary Outcome
Title Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16
Hide Description The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Arm/Group Title Placebo Guselkumab
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Overall Number of Participants Analyzed 174 329
Measure Type: Number
Unit of Measure: percentage of participants
6.9 85.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Arm/Group Title Placebo Guselkumab
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Overall Number of Participants Analyzed 174 329
Measure Type: Number
Unit of Measure: percentage of participants
2.9 73.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
Hide Description The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame Week 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.
Arm/Group Title Guselkumab Adalimumab
Hide Arm/Group Description:
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
Overall Number of Participants Analyzed 329 334
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 52.6 29.3
Week 48 50.5 25.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab, Adalimumab
Comments Week 24
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Guselkumab, Adalimumab
Comments Week 48
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
Hide Description The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame Week 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.
Arm/Group Title Guselkumab Adalimumab
Hide Arm/Group Description:
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
Overall Number of Participants Analyzed 329 334
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 84.2 61.7
Week 48 80.5 55.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab, Adalimumab
Comments Week 24
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Guselkumab, Adalimumab
Comments Week 48
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Time Frame Week 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.
Arm/Group Title Guselkumab Adalimumab
Hide Arm/Group Description:
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
Overall Number of Participants Analyzed 329 334
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 80.2 53.0
Week 48 76.3 47.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab, Adalimumab
Comments Week 24
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Guselkumab, Adalimumab
Comments Week 48
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
Hide Description The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set included all participants who were randomized at Week 0 and have a baseline DLQI score.
Arm/Group Title Placebo Guselkumab
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Overall Number of Participants Analyzed 174 329
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.6  (6.36) -11.2  (7.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab
Comments p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16
Hide Description The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Arm/Group Title Guselkumab Adalimumab
Hide Arm/Group Description:
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 15 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12.
Overall Number of Participants Analyzed 329 334
Measure Type: Number
Unit of Measure: percentage of participants
85.1 65.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab, Adalimumab
Comments p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments non-inferiority margin= 10.0%
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method MH Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 19.3
Confidence Interval (2-Sided) 95%
12.9 to 25.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Guselkumab, Adalimumab
Comments p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Arm/Group Title Guselkumab Adalimumab
Hide Arm/Group Description:
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 15 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12.
Overall Number of Participants Analyzed 329 334
Measure Type: Number
Unit of Measure: percentage of participants
73.3 49.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab, Adalimumab
Comments p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments non-inferiority margin= 10.0%
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method MH Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 24.1
Confidence Interval (2-Sided) 95%
17.0 to 31.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Guselkumab, Adalimumab
Comments p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Arm/Group Title Guselkumab Adalimumab
Hide Arm/Group Description:
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 15 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12.
Overall Number of Participants Analyzed 329 334
Measure Type: Number
Unit of Measure: percentage of participants
91.2 73.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab, Adalimumab
Comments p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments non-inferiority margin= 10%
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method MH Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 18.0
Confidence Interval (2-Sided) 95%
12.4 to 23.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Guselkumab, Adalimumab
Comments p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group
Hide Description The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
Time Frame Week 16
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Hide Analysis Population Description
Population analyzed included only randomized participants at Week 0 who had an ss-IGA score greater than or equal to (>=) 2 at baseline.
Arm/Group Title Placebo Guselkumab
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Overall Number of Participants Analyzed 145 277
Measure Type: Number
Unit of Measure: percentage of participants
14.5 83.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab
Comments p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
Hide Description The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
Time Frame Baseline and Week 16
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Hide Analysis Population Description
PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit.
Arm/Group Title Placebo Guselkumab
Hide Arm/Group Description:
Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Overall Number of Participants Analyzed 129 249
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.0  (19.56) -41.9  (24.61)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guselkumab
Comments p value is based on ANOVA model stratified by investigator site (pooled).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24
Hide Description The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0.
Arm/Group Title Guselkumab Adalimumab
Hide Arm/Group Description:
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
Overall Number of Participants Analyzed 248 273
Measure Type: Number
Unit of Measure: percentage of participants
36.3 21.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guselkumab, Adalimumab
Comments p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Time Frame Baseline (Week 0) up to Week 48
Adverse Event Reporting Description Safety analysis included all participants who were randomized at Week 0, received at least 1 dose of study agent. Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both the periods for safety data.
 
Arm/Group Title Placebo (PCP) Guselkumab 100 mg (PCP) Adalimumab (PCP) Placebo Then Guselkumab 100 mg (ACP) Guselkumab 100 mg (ACP) Adalimumab (ACP)
Hide Arm/Group Description Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period. Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period. Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Week 1 and once every other week thereafter through Week 15 during the placebo controlled period. Participants initially randomized to placebo crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 in the active controlled period (ACP). Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47. Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
All-Cause Mortality
Placebo (PCP) Guselkumab 100 mg (PCP) Adalimumab (PCP) Placebo Then Guselkumab 100 mg (ACP) Guselkumab 100 mg (ACP) Adalimumab (ACP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo (PCP) Guselkumab 100 mg (PCP) Adalimumab (PCP) Placebo Then Guselkumab 100 mg (ACP) Guselkumab 100 mg (ACP) Adalimumab (ACP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/174 (1.72%)   8/329 (2.43%)   6/333 (1.80%)   5/165 (3.03%)   8/324 (2.47%)   10/326 (3.07%) 
Cardiac disorders             
Acute Myocardial Infarction * 1  0/174 (0.00%)  0/329 (0.00%)  1/333 (0.30%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Cardiac Failure * 1  0/174 (0.00%)  0/329 (0.00%)  1/333 (0.30%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Myocardial Infarction * 1  0/174 (0.00%)  1/329 (0.30%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Myocardial Ischaemia * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  1/326 (0.31%) 
Sinus Node Dysfunction * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  1/165 (0.61%)  0/324 (0.00%)  0/326 (0.00%) 
Congenital, familial and genetic disorders             
Dermoid Cyst * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  1/324 (0.31%)  0/326 (0.00%) 
Gastrointestinal disorders             
Gastritis * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  1/324 (0.31%)  0/326 (0.00%) 
Haemorrhoids * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  1/165 (0.61%)  0/324 (0.00%)  0/326 (0.00%) 
Umbilical Hernia * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  1/324 (0.31%)  0/326 (0.00%) 
General disorders             
Non-Cardiac Chest Pain * 1  0/174 (0.00%)  1/329 (0.30%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Hepatobiliary disorders             
Cholecystitis * 1  0/174 (0.00%)  1/329 (0.30%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Cholelithiasis * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  1/326 (0.31%) 
Ischaemic Hepatitis * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  1/326 (0.31%) 
Infections and infestations             
Abdominal Abscess * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  1/326 (0.31%) 
Abscess * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  1/324 (0.31%)  0/326 (0.00%) 
Anal Abscess * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  1/165 (0.61%)  0/324 (0.00%)  0/326 (0.00%) 
Appendicitis * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  2/326 (0.61%) 
Cellulitis * 1  0/174 (0.00%)  0/329 (0.00%)  2/333 (0.60%)  0/165 (0.00%)  1/324 (0.31%)  0/326 (0.00%) 
Pneumonia Staphylococcal * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  1/326 (0.31%) 
Postoperative Wound Infection * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  1/324 (0.31%)  0/326 (0.00%) 
Injury, poisoning and procedural complications             
Cervical Vertebral Fracture * 1  0/174 (0.00%)  0/329 (0.00%)  1/333 (0.30%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Clavicle Fracture * 1  0/174 (0.00%)  1/329 (0.30%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Joint Dislocation * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  1/326 (0.31%) 
Meniscus Injury * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  1/165 (0.61%)  0/324 (0.00%)  0/326 (0.00%) 
Post Procedural Fistula * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  1/326 (0.31%) 
Radius Fracture * 1  0/174 (0.00%)  0/329 (0.00%)  1/333 (0.30%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back Pain * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  1/326 (0.31%) 
Meniscal Degeneration * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  1/165 (0.61%)  0/324 (0.00%)  0/326 (0.00%) 
Osteoarthritis * 1  1/174 (0.57%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Spondylolisthesis * 1  0/174 (0.00%)  1/329 (0.30%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Invasive Papillary Breast Carcinoma * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  1/324 (0.31%)  0/326 (0.00%) 
Nervous system disorders             
Paraesthesia * 1  0/174 (0.00%)  1/329 (0.30%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Psychiatric disorders             
Anxiety * 1  1/174 (0.57%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Psychotic Disorder * 1  0/174 (0.00%)  1/329 (0.30%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Suicide Attempt * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  1/326 (0.31%) 
Renal and urinary disorders             
Acute Kidney Injury * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  1/324 (0.31%)  0/326 (0.00%) 
Calculus Ureteric * 1  0/174 (0.00%)  1/329 (0.30%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Urinary Retention * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  1/324 (0.31%)  0/326 (0.00%) 
Skin and subcutaneous tissue disorders             
Erythrodermic Psoriasis * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  1/326 (0.31%) 
Lichen Planus * 1  0/174 (0.00%)  0/329 (0.00%)  0/333 (0.00%)  1/165 (0.61%)  0/324 (0.00%)  0/326 (0.00%) 
Psoriasis * 1  1/174 (0.57%)  0/329 (0.00%)  0/333 (0.00%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
Vascular disorders             
Peripheral Artery Stenosis * 1  0/174 (0.00%)  0/329 (0.00%)  1/333 (0.30%)  0/165 (0.00%)  0/324 (0.00%)  0/326 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (PCP) Guselkumab 100 mg (PCP) Adalimumab (PCP) Placebo Then Guselkumab 100 mg (ACP) Guselkumab 100 mg (ACP) Adalimumab (ACP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   39/174 (22.41%)   69/329 (20.97%)   62/333 (18.62%)   51/165 (30.91%)   103/324 (31.79%)   102/326 (31.29%) 
Infections and infestations             
Nasopharyngitis * 1  17/174 (9.77%)  30/329 (9.12%)  35/333 (10.51%)  34/165 (20.61%)  65/324 (20.06%)  57/326 (17.48%) 
Upper Respiratory Tract Infection * 1  9/174 (5.17%)  25/329 (7.60%)  16/333 (4.80%)  17/165 (10.30%)  31/324 (9.57%)  33/326 (10.12%) 
Nervous system disorders             
Headache * 1  7/174 (4.02%)  12/329 (3.65%)  13/333 (3.90%)  1/165 (0.61%)  7/324 (2.16%)  17/326 (5.21%) 
Skin and subcutaneous tissue disorders             
Pruritus * 1  10/174 (5.75%)  5/329 (1.52%)  7/333 (2.10%)  0/165 (0.00%)  3/324 (0.93%)  6/326 (1.84%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.1
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.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Research & Development, LLC
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02207231    
Other Study ID Numbers: CR105047
CNTO1959PSO3001 ( Other Identifier: Janssen Research & Development, LLC )
2014-000719-15 ( EudraCT Number )
First Submitted: July 31, 2014
First Posted: August 4, 2014
Results First Submitted: July 25, 2017
Results First Posted: October 19, 2017
Last Update Posted: August 13, 2020