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Trial record 37 of 762 for:    plaque | "Psoriasis"

Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis

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ClinicalTrials.gov Identifier: NCT02581345
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : September 12, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Chronic Plaque Psoriasis
Psoriasis
Interventions Biological: M923
Biological: Humira
Enrollment 572

Recruitment Details A total of 572 participants were enrolled and randomized equally into M923 and European Union reference protein product (EU RPP) arms. One participant in each arm did not receive any treatment. The 263 participants completing EU RPP treatment in Part 1 were randomized to 1 of 2 treatment arms in Part 2 (Transition and Continuous).
Pre-assignment Details  
Arm/Group Title Part 1 and Part 2: M923 Part 1: EU RPP Part 1: EU RPP; Part 2: Transition Part 1: EU RPP; Part 2: Continous
Hide Arm/Group Description Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 [IgG1] monoclonal antibody specific for human tumor necrosis factor–alpha [TNF-α]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection. Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47). Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Period Title: Part 1: up to Week 16
Started 286 286 0 0
Completed 271 263 0 0
Not Completed 15 23 0 0
Reason Not Completed
Adverse Event             3             8             0             0
Physician Decision             2             4             0             0
Withdrawal by Subject             4             7             0             0
Lost to Follow-up             2             0             0             0
Unspecified Reason             3             3             0             0
Did Not Receive Treatment             1             1             0             0
Period Title: Part 2: Week 17 to Week 47
Started 271 0 132 131
Completed 242 0 117 119
Not Completed 29 0 15 12
Reason Not Completed
Adverse Event             5             0             2             2
Physician Decision             3             0             2             1
Withdrawal by Subject             9             0             7             5
Failure to Achieve at Least a PASI 50             8             0             3             2
Lost to Follow-up             2             0             0             1
Unspecified Reason             2             0             1             1
Arm/Group Title Part 1 and Part 2: M923 Part 1 and Part 2: EU RPP Total
Hide Arm/Group Description Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 [IgG1] monoclonal antibody specific for human tumor necrosis factor–alpha [TNF-α]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 48 as a subcutaneous injection. Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. Participants from this arm were then randomized at Week 16 into either Arm: Continuous EU RPP (continued EU RPP from Weeks 17 to 48 [last dose at Week 47]) or Arm: Transition EU RPP (transition to M923 at Week 17; then to EU RPP at Week 25; and then to M923 at Week 37 [last dose at Week 47]). Total of all reporting groups
Overall Number of Baseline Participants 286 286 572
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) Analysis Set: all consenting participants randomized to study treatment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 286 participants 286 participants 572 participants
44.6  (12.4) 45.5  (12.9) 45.0  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 286 participants 572 participants
Female
95
  33.2%
100
  35.0%
195
  34.1%
Male
191
  66.8%
186
  65.0%
377
  65.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 286 participants 572 participants
American Indian or Alaska Native
0
   0.0%
1
   0.3%
1
   0.2%
Asian
2
   0.7%
1
   0.3%
3
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   1.0%
1
   0.3%
4
   0.7%
White
281
  98.3%
282
  98.6%
563
  98.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   0.3%
1
   0.2%
Psoriasis Area and Severity Index (PASI) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 285 participants 285 participants 570 participants
21.24  (9.27) 20.16  (8.16) 20.70  (8.74)
[1]
Measure Description: The PASI measures the average redness (erythema), thickness (induration), and scaliness [each graded on a scale of 0 (no disease) to 4 (very severe)] of psoriasis lesions, weighted by the area of involvement. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
[2]
Measure Analysis Population Description: Analysis was conducted using the Modified Intent-to-treat (mITT) Analysis Set including all consenting subjects randomized to study treatment (Arm A or Arm B) and contributed post-baseline data for at least one efficacy endpoint.
Number of Participants with the Indicated Static Physician’s Global Assessment (sPGA) Score   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 285 participants 285 participants 570 participants
Moderate
170
  59.6%
182
  63.9%
352
  61.8%
Severe
103
  36.1%
91
  31.9%
194
  34.0%
Very Severe
12
   4.2%
12
   4.2%
24
   4.2%
Clear
0
   0.0%
0
   0.0%
0
   0.0%
Almost Clear
0
   0.0%
0
   0.0%
0
   0.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).
[2]
Measure Analysis Population Description: mITT Analysis Set
1.Primary Outcome
Title Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16
Hide Description The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 75 are defined as having an improvement (reduction) of at least 75% in the Week 16 PASI score compared to the score at Baseline.
Time Frame Baseline; Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) Analysis Set: subgroup of the Intent-To-Treat (ITT) Analysis Set that included all participants who did not have any deviations from the protocol deemed significant enough for exclusion from the efficacy analysis and received at least 1 dose of study drug
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 [IgG1] monoclonal antibody specific for human tumor necrosis factor–alpha [TNF-α]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 267 271
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80.1
(74.9 to 84.8)
79.0
(73.6 to 83.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: M923, Part 1: EU RPP
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Per Food and Drug Administration (FDA), the equivalence testing was made using 90% confidence interval and an equivalence margin of 18%
Method of Estimation Estimation Parameter Difference in proportion (M923 - EU RPP)
Estimated Value 0.014
Confidence Interval (2-Sided) 90%
-0.043 to 0.072
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: M923, Part 1: EU RPP
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Per European Medicines Agency (EMA), the equivalence testing was made using 95% confidence interval and an equivalence margin of 15%
Method of Estimation Estimation Parameter Difference in proportion (M923 - EU RPP)
Estimated Value 0.014
Confidence Interval (2-Sided) 95%
-0.054 to 0.082
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With a Response of Clear or Almost Clear on the Static Physician Global Assessment (sPGA) at Week 16
Hide Description The sPGA response rate was defined as the percentage of participants who had achieved a clear or almost clear response on the 6-point sPGA scale. The sPGA was the physician’s determination of the participant’s psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis was assessed at a given time point on a 6-point scale on which 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 267 271
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68.9
(63.0 to 74.4)
66.1
(60.1 to 71.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: M923, Part 1: EU RPP
Comments [Not Specified]
Type of Statistical Test Other
Comments No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale was calculated using stratified Newcombe method.
Method of Estimation Estimation Parameter Difference in proportion (M923 - EU RPP)
Estimated Value 0.031
Confidence Interval (2-Sided) 95%
-0.048 to 0.110
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Achieving PASI 50 Response at Week 16
Hide Description The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 50 are defined as having an improvement (reduction) of at least 50% compared to Baseline.
Time Frame Baseline; Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 267 271
Measure Type: Count of Participants
Unit of Measure: Participants
243
  91.0%
253
  93.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: M923, Part 1: EU RPP
Comments [Not Specified]
Type of Statistical Test Other
Comments No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: [-0.18;+0.18] for 90% confidence interval.
Method of Estimation Estimation Parameter Difference in proportion (M923 - EU RPP)
Estimated Value -0.022
Confidence Interval (2-Sided) 90%
-0.061 to 0.016
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: M923, Part 1: EU RPP
Comments [Not Specified]
Type of Statistical Test Other
Comments No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: [-0.15;+0.15] for 95% confidence interval.
Method of Estimation Estimation Parameter Difference in proportion (M923 - EU RPP)
Estimated Value -0.022
Confidence Interval (2-Sided) 95%
-0.069 to 0.024
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Achieving PASI 50 Response at Week 52 (Follow-Up Visit)
Hide Description The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 50 are defined as having an improvement (reduction) of at least 50% compared to Baseline.
Time Frame Baseline; Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.
Arm/Group Title Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 258 130 129
Measure Type: Count of Participants
Unit of Measure: Participants
228
  88.4%
111
  85.4%
113
  87.6%
5.Secondary Outcome
Title Number of Participants Achieving PASI 75 Response at Week 52 (Follow-Up Visit)
Hide Description The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 75 are defined as having an improvement (reduction) of at least 75% compared to Baseline.
Time Frame Baseline; Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.
Arm/Group Title Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 258 130 129
Measure Type: Count of Participants
Unit of Measure: Participants
202
  78.3%
96
  73.8%
101
  78.3%
6.Secondary Outcome
Title Number of Participants Achieving PASI 90 Response at Week 16
Hide Description The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 90 are defined as having an improvement (reduction) of at least 90% compared to Baseline.
Time Frame Baseline; Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 267 271
Measure Type: Count of Participants
Unit of Measure: Participants
165
  61.8%
147
  54.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: M923, Part 1: EU RPP
Comments [Not Specified]
Type of Statistical Test Other
Comments No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: [-0.18;+0.18] for 90% confidence interval.
Method of Estimation Estimation Parameter Difference in proportion (M923 - EU RPP)
Estimated Value 0.080
Confidence Interval (2-Sided) 90%
0.010 to 0.149
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: M923, Part 1: EU RPP
Comments [Not Specified]
Type of Statistical Test Other
Comments No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are:[-0.15;+0.15] for 95% confidence interval.
Method of Estimation Estimation Parameter Difference in proportion (M923 - EU RPP)
Estimated Value 0.080
Confidence Interval (2-Sided) 95%
-0.004 to 0.162
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants Achieving PASI 90 Response at Week 52 (Follow-Up Visit)
Hide Description The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 90 are defined as having an improvement (reduction) of at least 90% compared to Baseline.
Time Frame Baseline; Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.
Arm/Group Title Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 258 130 129
Measure Type: Count of Participants
Unit of Measure: Participants
159
  61.6%
71
  54.6%
77
  59.7%
8.Secondary Outcome
Title Absolute PASI Score at Baseline
Hide Description The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using PP Analysis Set including participants with evaluable data for part 1 and part 2 of the study are included in the analyses.
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 267 271
Mean (Standard Deviation)
Unit of Measure: units on a scale
21.34  (9.268) 20.29  (8.266)
9.Secondary Outcome
Title Absolute PASI Score at Week 16
Hide Description The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set. Only those participants contributing data at Week 16 were analyzed.
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 261 263
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.58  (4.092) 2.50  (3.098)
10.Secondary Outcome
Title Absolute PASI Score at Week 52 (Follow-Up Visit)
Hide Description The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score.
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.
Arm/Group Title Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 246 120 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.76  (4.768) 2.85  (4.913) 2.67  (3.919)
11.Secondary Outcome
Title Percent Change From Baseline in PASI Score at Week 16
Hide Description The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Percent change from Baseline was calculated as: (post-Baseline value – Baseline value) / (Baseline value) * 100.
Time Frame Baseline; Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set. Only those participants contributing data at Week 16 were analyzed.
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 261 263
Mean (Standard Deviation)
Unit of Measure: percent change
-86.21  (20.065) -86.79  (15.756)
12.Secondary Outcome
Title Percent Change From Baseline in PASI Score at Week 52 (Follow-Up Visit)
Hide Description The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Percent change from Baseline was calculated as: (post-Baseline value – Baseline value) / (Baseline value) * 100.
Time Frame Baseline; Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.
Arm/Group Title Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 246 120 124
Mean (Standard Deviation)
Unit of Measure: percent change
-86.43  (22.570) -85.53  (21.771) -85.64  (20.968)
13.Secondary Outcome
Title Health-Related Quality of Life During Treatment: Dermatology Life Quality Index (DLQI) Score at Baseline
Hide Description The DLQI score was calculated by summing the individual scores of each question at a given time point, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. For the analysis of responses, the participant's results were assessed on a scoring scale on which 3 = very much or yes (applicable to question 7 only), 2 = a lot, 1 = a little, 0 = not at all or not relevant. Interpretation of DLQI scoring can be taken as 0 – 1 = no effect at all on participant's life, 2 – 5 = small effect on participant's life, 6 – 10 = moderate effect on participant's life, 11 – 20 = very large effect on participant's life, and 21 – 30 = extremely large effect on participant's life.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using PP Analysis Set including participants with evaluable data for part 1 and part 2 of the study.
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 267 271
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.5  (7.13) 10.5  (6.71)
14.Secondary Outcome
Title Health-Related Quality of Life During Treatment: DLQI Score at Week 16
Hide Description The DLQI score was calculated by summing the individual scores of each question at a given time point, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. For the analysis of responses, the participant's results were assessed on a scoring scale on which 3 = very much or yes (applicable to question 7 only), 2 = a lot, 1 = a little, 0 = not at all or not relevant. Interpretation of DLQI scoring can be taken as 0 – 1 = no effect at all on participant's life, 2 – 5 = small effect on participant's life, 6 – 10 = moderate effect on participant's life, 11 – 20 = very large effect on participant's life, and 21 – 30 = extremely large effect on participant's life.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set. Only those participants contributing data at Week 16 were analyzed.
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 258 259
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.4  (4.04) 2.1  (3.50)
15.Secondary Outcome
Title Health-Related Quality of Life During Treatment: DLQI Score at Week 48 (Completion/Termination Visit)
Hide Description The DLQI score was calculated by summing the individual scores of each question at a given time point, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. For the analysis of responses, the participant's results were assessed on a scoring scale on which 3 = very much or yes (applicable to question 7 only), 2 = a lot, 1 = a little, 0 = not at all or not relevant. Interpretation of DLQI scoring can be taken as 0 – 1 = no effect at all on participant's life, 2 – 5 = small effect on participant's life, 6 – 10 = moderate effect on participant's life, 11 – 20 = very large effect on participant's life, and 21 – 30 = extremely large effect on participant's life.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set. Only those participants contributing data at Week 48 were analyzed.
Arm/Group Title Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 232 115 117
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.1  (3.77) 1.6  (2.83) 2.1  (3.97)
16.Secondary Outcome
Title Health-Related Quality of Life During Treatment: EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D-5L) at Baseline
Hide Description The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = "worst health you can imagine" and 100 = "best health you can imagine". Baseline was defined as the last scheduled observation prior to dosing, typically Day 1, predose.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using PP Analysis Set including participants with evaluable data for part 1 and part 2 of the study.
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 267 271
Mean (Standard Deviation)
Unit of Measure: units on a scale
71.3  (18.70) 72.5  (20.27)
17.Secondary Outcome
Title Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 16
Hide Description The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = "worst health you can imagine" and 100 = "best health you can imagine".
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set. Only those participants contributing data at Week 16 were analyzed.
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 258 259
Mean (Standard Deviation)
Unit of Measure: units on a scale
83.7  (12.38) 83.4  (13.92)
18.Secondary Outcome
Title Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 48 (Completion/Termination Visit)
Hide Description The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = "worst health you can imagine" and 100 = "best health you can imagine".
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP Analysis Set. Only those participants contributing data at Week 48 were analyzed.
Arm/Group Title Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 232 115 117
Mean (Standard Deviation)
Unit of Measure: units on a scale
85.3  (13.83) 83.9  (14.92) 84.2  (12.98)
19.Secondary Outcome
Title Number of Participants With Clinically Meaningful Changes in Vital Signs
Hide Description Vital signs included body temperature, respiratory rate, pulse rate, systolic and diastolic blood pressure, and weight. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.
Time Frame Up to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Part 1: M923 Part 1: EU RPP Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 285 285 271 132 131
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
20.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline
Hide Description Laboratory results included hematology [Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes, Eosinophils absolute, and Eosinophils], chemistry (Aspartate transaminase, Alanine transaminase, Gamma glutamyl transferase, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Potassium, Urea, Creatinine, Phosphate, Glucose, and Uric acid) and urinalysis [Specific Gravity] parameters. Laboratory results of a few hematology (Red Blood Cell Count and Monocytes absolute), chemistry (Alkaline Phosphatase, Total bilirubin, Sodium, Chloride, and Albumin), and urinalysis (pH) parameters were not assessed at Baseline and Week 16. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 285 285
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin
0
   0.0%
0
   0.0%
Hematocrit
0
   0.0%
0
   0.0%
Platelet count
0
   0.0%
0
   0.0%
Mean cell volume
0
   0.0%
0
   0.0%
White blood cell count (total leucocytes)
1
   0.4%
1
   0.4%
Neutrophils absolute
2
   0.7%
1
   0.4%
Neutrophils
1
   0.4%
0
   0.0%
Lymphocytes absolute
1
   0.4%
1
   0.4%
Lymphocytes
1
   0.4%
1
   0.4%
Monocytes
0
   0.0%
0
   0.0%
Eosinophils absolute
0
   0.0%
0
   0.0%
Eosinophils
0
   0.0%
0
   0.0%
Aspartate transaminase
0
   0.0%
0
   0.0%
Alanine transaminase
1
   0.4%
1
   0.4%
Gamma glutamyl transferase
1
   0.4%
4
   1.4%
Creatine kinase
2
   0.7%
0
   0.0%
C-reactive protein
6
   2.1%
2
   0.7%
Cholesterol
2
   0.7%
4
   1.4%
Triglycerides
3
   1.1%
2
   0.7%
Total protein
0
   0.0%
1
   0.4%
Potassium
1
   0.4%
0
   0.0%
Urea
1
   0.4%
0
   0.0%
Creatinine
0
   0.0%
0
   0.0%
Phosphate
0
   0.0%
0
   0.0%
Glucose
1
   0.4%
2
   0.7%
Uric acid
2
   0.7%
0
   0.0%
Specific Gravity
0
   0.0%
0
   0.0%
21.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16
Hide Description Laboratory results included hematology [Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes, Eosinophils absolute, and Eosinophils], chemistry (Aspartate transaminase, Alanine transaminase, Gamma glutamyl transferase, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Potassium, Urea, Creatinine, Phosphate, Glucose, and Uric acid) and urinalysis [Specific Gravity] parameters. Laboratory results of a few hematology (Red Blood Cell Count and Monocytes absolute), chemistry (Alkaline Phosphatase, Total bilirubin, Sodium, Chloride, and Albumin), and urinalysis (pH) parameters were not assessed at Baseline and Week 16. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 285 285
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin
1
   0.4%
1
   0.4%
Hematocrit
1
   0.4%
1
   0.4%
Platelet count
0
   0.0%
0
   0.0%
Mean cell volume
0
   0.0%
1
   0.4%
White blood cell count (total leucocytes)
2
   0.7%
0
   0.0%
Neutrophils absolute
1
   0.4%
0
   0.0%
Neutrophils
0
   0.0%
0
   0.0%
Lymphocytes absolute
0
   0.0%
1
   0.4%
Lymphocytes
0
   0.0%
1
   0.4%
Monocytes
0
   0.0%
0
   0.0%
Eosinophils absolute
1
   0.4%
0
   0.0%
Eosinophils
1
   0.4%
0
   0.0%
Aspartate transaminase
2
   0.7%
0
   0.0%
Alanine transaminase
3
   1.1%
1
   0.4%
Gamma glutamyl transferase
3
   1.1%
2
   0.7%
Creatine kinase
2
   0.7%
0
   0.0%
C-reactive protein
1
   0.4%
0
   0.0%
Cholesterol
4
   1.4%
3
   1.1%
Triglycerides
5
   1.8%
3
   1.1%
Total protein
0
   0.0%
1
   0.4%
Potassium
1
   0.4%
0
   0.0%
Urea
0
   0.0%
0
   0.0%
Creatinine
0
   0.0%
0
   0.0%
Phosphate
0
   0.0%
0
   0.0%
Glucose
2
   0.7%
3
   1.1%
Uric acid
1
   0.4%
1
   0.4%
Specific Gravity
0
   0.0%
0
   0.0%
22.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit)
Hide Description Laboratory results included hematology [Red Blood Cell Count, Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes absolute, Monocytes, Eosinophils absolute, and Eosinophils], chemistry (Aspartate transaminase, Alanine transaminase, Alkaline Phosphatase, Gamma glutamyl transferase, Total bilirubin, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Sodium, Potassium, Chloride, Urea, Creatinine, Albumin, Phosphate, Glucose, and Uric acid) and urinalysis [pH and Specific Gravity] parameters. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 271 132 131
Measure Type: Count of Participants
Unit of Measure: Participants
Red Blood Cell Count
1
   0.4%
0
   0.0%
1
   0.8%
Hemoglobin
1
   0.4%
0
   0.0%
1
   0.8%
Hematocrit
1
   0.4%
0
   0.0%
1
   0.8%
Platelet count
1
   0.4%
0
   0.0%
0
   0.0%
Mean cell volume
0
   0.0%
0
   0.0%
1
   0.8%
White blood cell count (total leucocytes)
2
   0.7%
1
   0.8%
1
   0.8%
Neutrophils absolute
3
   1.1%
1
   0.8%
2
   1.5%
Neutrophils
3
   1.1%
0
   0.0%
0
   0.0%
Lymphocytes absolute
0
   0.0%
0
   0.0%
1
   0.8%
Lymphocytes
1
   0.4%
0
   0.0%
0
   0.0%
Monocytes absolute
0
   0.0%
0
   0.0%
0
   0.0%
Monocytes
1
   0.4%
0
   0.0%
0
   0.0%
Eosinophils absolute
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils
2
   0.7%
0
   0.0%
0
   0.0%
Aspartate transaminase
2
   0.7%
0
   0.0%
1
   0.8%
Alanine transaminase
5
   1.8%
0
   0.0%
3
   2.3%
Alkaline Phosphatase
0
   0.0%
0
   0.0%
0
   0.0%
Gamma glutamyl transferase
3
   1.1%
0
   0.0%
3
   2.3%
Total bilirubin
1
   0.4%
0
   0.0%
1
   0.8%
Creatine kinase
0
   0.0%
1
   0.8%
1
   0.8%
C-reactive protein
3
   1.1%
0
   0.0%
0
   0.0%
Cholesterol
7
   2.6%
3
   2.3%
2
   1.5%
Triglycerides
11
   4.1%
4
   3.0%
2
   1.5%
Total protein
0
   0.0%
0
   0.0%
0
   0.0%
Sodium
0
   0.0%
0
   0.0%
0
   0.0%
Potassium
0
   0.0%
0
   0.0%
0
   0.0%
Chloride
0
   0.0%
0
   0.0%
0
   0.0%
Urea
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine
0
   0.0%
0
   0.0%
0
   0.0%
Albumin
0
   0.0%
0
   0.0%
0
   0.0%
Phosphate
0
   0.0%
0
   0.0%
0
   0.0%
Glucose
5
   1.8%
3
   2.3%
0
   0.0%
Uric acid
1
   0.4%
3
   2.3%
3
   2.3%
pH
1
   0.4%
1
   0.8%
0
   0.0%
Specific Gravity
0
   0.0%
0
   0.0%
0
   0.0%
23.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Baseline
Hide Description Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 285 285
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
24.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 16
Hide Description Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 285 285
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.7%
0
   0.0%
25.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 48 (Completion/Termination Visit)
Hide Description Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 271 132 131
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.1%
0
   0.0%
0
   0.0%
26.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Hide Description TEAEs are adverse events that occurred during or after study drug administration. For more details on adverse events please refer the safety section.
Time Frame Up to Week 52
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Safety Analysis Set
Arm/Group Title Part 1: M923 Part 1: EU RPP Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 285 285 271 132 131
Measure Type: Count of Participants
Unit of Measure: Participants
169
  59.3%
194
  68.1%
199
  73.4%
99
  75.0%
103
  78.6%
27.Secondary Outcome
Title Pharmacokinetics: Serum Concentrations by Treatment
Hide Description Serum samples were collected at Baseline (Week 0, perdose), approximately 1 week (peak) after IP administration (Weeks 8 and 16), and 2 weeks after dose administration as a trough sample collected prior to the next dose administration (Weeks 17, 21, 25, 29, 37, 41).
Time Frame Baseline (Week 0), Week 8, 16, 17, 21, 25, 29, 37, and 41
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Hide Analysis Population Description
Pharmacokinetic (PK) Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 measured concentration at a scheduled PK time point after start of dosing. Only participants with evaluable data were analyzed.
Arm/Group Title Part 1: M923 Part 1: EU RPP Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 282 281 267 130 130
Mean (Standard Deviation)
Unit of Measure: nanograms per milliter (ng/mL)
Baseline (Week 0)/Predose Number Analyzed 279 participants 279 participants 0 participants 0 participants 0 participants
302  (16.5) 301  (9.69)
Week 8/Peak Number Analyzed 277 participants 272 participants 0 participants 0 participants 0 participants
9100  (5450) 7640  (4370)
Week 16/Peak Number Analyzed 268 participants 261 participants 0 participants 0 participants 0 participants
8580  (5700) 6990  (5100)
Week 17/Trough Number Analyzed 0 participants 0 participants 267 participants 130 participants 129 participants
6900  (5270) 5840  (4840) 5340  (4050)
Week 21/Trough Number Analyzed 0 participants 0 participants 257 participants 127 participants 130 participants
6630  (4960) 6260  (4960) 5100  (4040)
Week 25/Trough Number Analyzed 0 participants 0 participants 252 participants 126 participants 127 participants
6790  (5210) 6320  (5260) 4970  (3870)
Week 29/Trough Number Analyzed 0 participants 0 participants 248 participants 125 participants 124 participants
5990  (4020) 5330  (4000) 4840  (3480)
Week 37/Trough Number Analyzed 0 participants 0 participants 245 participants 121 participants 120 participants
6120  (4220) 5250  (4190) 4830  (3680)
Week 41/Trough Number Analyzed 0 participants 0 participants 241 participants 119 participants 117 participants
5950  (4230) 5480  (4140) 4740  (3710)
28.Secondary Outcome
Title Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA) at Baseline
Hide Description The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.
Time Frame Baseline (Week 0)
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Safety Analysis Set
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 285 285
Measure Type: Count of Participants
Unit of Measure: Participants
EU Humera
15
   5.3%
11
   3.9%
M923
1
   0.4%
2
   0.7%
Overall Results
16
   5.6%
13
   4.6%
Neutralizing ADA
4
   1.4%
2
   0.7%
29.Secondary Outcome
Title Immunogenicity: Number of Participants With ADA at Week 16
Hide Description The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.
Time Frame Week 16
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Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 285 285
Measure Type: Count of Participants
Unit of Measure: Participants
EU Humera
135
  47.4%
144
  50.5%
M923
4
   1.4%
8
   2.8%
Overall Results
139
  48.8%
152
  53.3%
Neutralizing ADA
28
   9.8%
30
  10.5%
30.Secondary Outcome
Title Immunogenicity: Number of Participants With ADA at Week 25
Hide Description The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.
Time Frame Week 25
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Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 271 132 131
Measure Type: Count of Participants
Unit of Measure: Participants
EU Humera
144
  53.1%
80
  60.6%
92
  70.2%
M923
12
   4.4%
5
   3.8%
5
   3.8%
Overall result
156
  57.6%
85
  64.4%
97
  74.0%
Neutralizing ADA
55
  20.3%
25
  18.9%
32
  24.4%
31.Secondary Outcome
Title Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit)
Hide Description The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 271 132 131
Measure Type: Count of Participants
Unit of Measure: Participants
EU Humera
131
  48.3%
73
  55.3%
80
  61.1%
M923
10
   3.7%
6
   4.5%
7
   5.3%
Overall result
141
  52.0%
79
  59.8%
87
  66.4%
Neutralizing ADA
40
  14.8%
28
  21.2%
23
  17.6%
32.Secondary Outcome
Title Immunogenicity: Number of Participants With ADA and nADA by Titer at Baseline
Hide Description The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.
Time Frame Baseline (Week 0)
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Safety Analysis Set
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 285 285
Measure Type: Count of Participants
Unit of Measure: Participants
No positive result
266
  93.3%
271
  95.1%
Predose positive result
16
   5.6%
13
   4.6%
33.Secondary Outcome
Title Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16
Hide Description The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.
Time Frame Week 16
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Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Part 1: M923 Part 1: EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.
Overall Number of Participants Analyzed 285 285
Measure Type: Count of Participants
Unit of Measure: Participants
Titers ≤ 1:16 (postdose positive ADAs)
16
   5.6%
26
   9.1%
Titers ≤ 1:16 (postdose positive nADAs)
2
   0.7%
2
   0.7%
Titers > 1:16 to ≤ 1:128 (postdose positive ADAs)
90
  31.6%
73
  25.6%
Titers > 1:16 to ≤ 1:128 (postdose positive nADAs)
17
   6.0%
6
   2.1%
Titers >1:128 to ≤ 1:152 (postdose positive ADAs)
27
   9.5%
40
  14.0%
Titers >1:128 to ≤ 1:152 (postdose positive nADAs)
3
   1.1%
11
   3.9%
Titers >1:152 (postdose positive ADAs)
6
   2.1%
13
   4.6%
Titers >1:152 (postdose positive nADAs)
6
   2.1%
11
   3.9%
34.Secondary Outcome
Title Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25
Hide Description The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.
Time Frame Week 25
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Safety Analysis Set
Arm/Group Title Part 1 and Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 48 as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 285 132 131
Measure Type: Count of Participants
Unit of Measure: Participants
Titers ≤ 1:16 (postdose positive ADAs)
24
   8.4%
19
  14.4%
21
  16.0%
Titers ≤ 1:16 (postdose positive nADAs)
6
   2.1%
2
   1.5%
4
   3.1%
Titers > 1:16 to ≤ 1:128 (postdose positive ADAs)
86
  30.2%
37
  28.0%
42
  32.1%
Titers > 1:16 to ≤ 1:128 (postdose positive nADAs)
17
   6.0%
4
   3.0%
7
   5.3%
Titers >1:128 to ≤ 1:152 (postdose positive ADAs)
28
   9.8%
14
  10.6%
22
  16.8%
Titers >1:128 to ≤ 1:152 (postdose positive nADAs)
16
   5.6%
6
   4.5%
10
   7.6%
Titers >1:152 (postdose positive ADAs)
18
   6.3%
15
  11.4%
12
   9.2%
Titers >1:152 (postdose positive nADAs)
16
   5.6%
13
   9.8%
11
   8.4%
35.Secondary Outcome
Title Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit)
Hide Description The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.
Time Frame Week 52
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Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Part 1 and Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 48 as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 285 132 131
Measure Type: Count of Participants
Unit of Measure: Participants
Titers ≤ 1:16 (postdose positive ADAs)
26
   9.1%
11
   8.3%
17
  13.0%
Titers ≤ 1:16 (postdose positive nADAs)
0
   0.0%
2
   1.5%
3
   2.3%
Titers > 1:16 to ≤ 1:128 (postdose positive ADAs)
62
  21.8%
37
  28.0%
38
  29.0%
Titers > 1:16 to ≤ 1:128 (postdose positive nADAs)
13
   4.6%
6
   4.5%
5
   3.8%
Titers >1:128 to ≤ 1:152 (postdose positive ADAs)
23
   8.1%
12
   9.1%
15
  11.5%
Titers >1:128 to ≤ 1:152 (postdose positive nADAs)
9
   3.2%
6
   4.5%
2
   1.5%
Titers >1:152 (postdose positive ADAs)
13
   4.6%
7
   5.3%
10
   7.6%
Titers >1:152 (postdose positive nADAs)
11
   3.9%
6
   4.5%
7
   5.3%
36.Secondary Outcome
Title Median Time to Seroconversion
Hide Description Time to seroconversion (in days) was defined as the time to the observation of the first confirmed positive ADA response. Participants with confirmed positive ADA response at baseline (Week 0 predose) were excluded.
Time Frame Up to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants who had a postdose seroconversion time were analyzed.
Arm/Group Title Part 1 and Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description:
Participants received 80 mg M923 at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 48 as a subcutaneous injection.
At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).
Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Overall Number of Participants Analyzed 216 106 120
Median (Full Range)
Unit of Measure: days
113.0
(52 to 372)
113.0
(51 to 375)
112.0
(54 to 373)
Time Frame Up to Week 52
Adverse Event Reporting Description Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product [EU RPP]).
 
Arm/Group Title Part 1: M923 Part 1: EU RPP Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Hide Arm/Group Description Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 [IgG1] monoclonal antibody specific for human tumor necrosis factor–alpha [TNF-α]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection. At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47). Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
All-Cause Mortality
Part 1: M923 Part 1: EU RPP Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/285 (0.00%)   0/285 (0.00%)   0/271 (0.00%)   0/132 (0.00%)   0/131 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Part 1: M923 Part 1: EU RPP Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/285 (1.40%)   7/285 (2.46%)   10/271 (3.69%)   10/132 (7.58%)   8/131 (6.11%) 
Cardiac disorders           
Acute Myocardial Infarction  1  0/285 (0.00%)  1/285 (0.35%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Myocardial ischaemia  1  0/285 (0.00%)  1/285 (0.35%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Angina pectoris  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  0/131 (0.00%) 
Cardiac failure  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  0/131 (0.00%) 
Cardiomyopathy  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  1/131 (0.76%) 
Hypertensive cardiomyopathy  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  0/131 (0.00%) 
Left ventricular failure  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  1/131 (0.76%) 
Supraventricular tachycardia  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  0/131 (0.00%) 
Ear and labyrinth disorders           
Vertigo  1  1/285 (0.35%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
General disorders           
Non-cardiac chest pain  1  0/285 (0.00%)  1/285 (0.35%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Hepatobiliary disorders           
Drug-induced liver injury  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  1/131 (0.76%) 
Immune system disorders           
Hypersensitivity  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  1/131 (0.76%) 
Infections and infestations           
Appendicitis  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  1/131 (0.76%) 
Peritonitis bacterial  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  1/132 (0.76%)  0/131 (0.00%) 
Peritonsillar abscess  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  1/131 (0.76%) 
Pyelonephritis  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  1/132 (0.76%)  0/131 (0.00%) 
Injury, poisoning and procedural complications           
Brain contusion  1  0/285 (0.00%)  1/285 (0.35%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Joint injury  1  1/285 (0.35%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Facial bones fracture  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  1/132 (0.76%)  0/131 (0.00%) 
Hip fracture  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  1/131 (0.76%) 
Meniscus injury  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  1/132 (0.76%)  1/131 (0.76%) 
Lumbar vertebral fracture  1  0/285 (0.00%)  1/285 (0.35%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Skull fractured base  1  0/285 (0.00%)  1/285 (0.35%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Investigations           
Ejection fraction decreased  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  1/131 (0.76%) 
Blood creatine phosphokinase increased  1  1/285 (0.35%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Musculoskeletal and connective tissue disorders           
Intervertebral disc protrusion  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  1/132 (0.76%)  0/131 (0.00%) 
Synovitis  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  1/132 (0.76%)  0/131 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Bladder papilloma  1  1/285 (0.35%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Bladder transitional cell carcinoma  1  1/285 (0.35%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Gastric adenoma  1  1/285 (0.35%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Benign ovarian tumor  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  0/131 (0.00%) 
Meningioma  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  0/131 (0.00%) 
Nodular melanoma  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  1/132 (0.76%)  0/131 (0.00%) 
Nervous system disorders           
Cerebral haemorrhage  1  0/285 (0.00%)  1/285 (0.35%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Epilepsy  1  0/285 (0.00%)  1/285 (0.35%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Cervical myelopathy  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  1/132 (0.76%)  0/131 (0.00%) 
Headache  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  1/132 (0.76%)  0/131 (0.00%) 
Syncope  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  0/131 (0.00%) 
Product Issues           
Device loosening  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  0/131 (0.00%) 
Psychiatric disorders           
Suicide attempt  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  0/131 (0.00%) 
Renal and urinary disorders           
Ureterolithiasis  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  1/131 (0.76%) 
Acute kidney injury  1  0/285 (0.00%)  1/285 (0.35%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Reproductive system and breast disorders           
Cervical dysplasia  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  1/132 (0.76%)  0/131 (0.00%) 
Endometrial hyperplasia  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  0/131 (0.00%) 
Genital prolapse  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  0/131 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Nasal septum deviation  1  0/285 (0.00%)  1/285 (0.35%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Skin and subcutaneous tissue disorders           
Rash generalised  1  0/285 (0.00%)  0/285 (0.00%)  0/271 (0.00%)  1/132 (0.76%)  0/131 (0.00%) 
Pruritus  1  0/285 (0.00%)  1/285 (0.35%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Pustular psoriasis  1  0/285 (0.00%)  1/285 (0.35%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Rash  1  0/285 (0.00%)  1/285 (0.35%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
Vascular disorders           
Arteriosclerosis  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  0/131 (0.00%) 
Peripheral vascular disorder  1  0/285 (0.00%)  0/285 (0.00%)  1/271 (0.37%)  0/132 (0.00%)  0/131 (0.00%) 
Hypertension  1  1/285 (0.35%)  0/285 (0.00%)  0/271 (0.00%)  0/132 (0.00%)  0/131 (0.00%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: M923 Part 1: EU RPP Part 2: M923 Part 2: Transition EU RPP Part 2: Continuous EU RPP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   92/285 (32.28%)   104/285 (36.49%)   96/271 (35.42%)   47/132 (35.61%)   63/131 (48.09%) 
General disorders           
Injection site reaction  1  68/285 (23.86%)  79/285 (27.72%)  27/271 (9.96%)  15/132 (11.36%)  19/131 (14.50%) 
Infections and infestations           
Nasopharyngitis  1  19/285 (6.67%)  17/285 (5.96%)  40/271 (14.76%)  16/132 (12.12%)  20/131 (15.27%) 
Upper respiratory tract infection  1  9/285 (3.16%)  6/285 (2.11%)  15/271 (5.54%)  6/132 (4.55%)  11/131 (8.40%) 
Nervous system disorders           
Headache  1  9/285 (3.16%)  10/285 (3.51%)  2/271 (0.74%)  7/132 (5.30%)  5/131 (3.82%) 
Skin and subcutaneous tissue disorders           
Psoriasis  1  8/285 (2.81%)  8/285 (2.81%)  28/271 (10.33%)  14/132 (10.61%)  21/131 (16.03%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Jim Jin
Organization: Momenta
Phone: +16173954905
Responsible Party: Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02581345     History of Changes
Other Study ID Numbers: 911401
First Submitted: October 19, 2015
First Posted: October 21, 2015
Results First Submitted: May 18, 2018
Results First Posted: September 12, 2018
Last Update Posted: October 17, 2018