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

• 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: Momenta Pharmaceuticals, Inc.
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Part 1 and Part 2: M923	Part 1 and Part 2: EU RPP	Total
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
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

Outcome Measures

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
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

Outcome Measure Data

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
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)

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]

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
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

Outcome Measure Data

Analysis Population Description

PP Analysis Set

Arm/Group Title	Part 1: M923	Part 1: EU RPP
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)

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
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

Outcome Measure Data

Analysis Population Description

PP Analysis Set

Arm/Group Title	Part 1: M923	Part 1: EU RPP
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%

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]

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)
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

PP Analysis Set

Arm/Group Title	Part 1: M923	Part 1: EU RPP
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%

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]

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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Part 1: M923	Part 1: EU RPP
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
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

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Part 1: M923	Part 1: EU RPP
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)
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

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Part 2: M923	Part 2: Transition EU RPP	Part 2: Continuous EU RPP
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
Description	Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Part 1: M923	Part 1: EU RPP
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
Description	Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Part 1: M923	Part 1: EU RPP
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)
Description	Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Part 2: M923	Part 2: Transition EU RPP	Part 2: Continuous EU RPP
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Part 1: M923	Part 1: EU RPP
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
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

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Part 1: M923	Part 1: EU RPP
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
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

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Part 2: M923	Part 2: Transition EU RPP	Part 2: Continuous EU RPP
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)
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

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Part 2: M923	Part 2: Transition EU RPP	Part 2: Continuous EU RPP
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
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)

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Part 1: M923	Part 1: EU RPP
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
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

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Part 1: M923	Part 1: EU RPP
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

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
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: jjin@momentapharma.com

• 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