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
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Sponsor:
Momenta Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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Intent-to-Treat (ITT) Analysis Set: all consenting participants randomized to study treatment
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 286 participants | 286 participants | 572 participants | |
Female |
95 33.2%
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100 35.0%
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195 34.1%
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Male |
191 66.8%
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186 65.0%
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377 65.9%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 286 participants | 286 participants | 572 participants | |
American Indian or Alaska Native |
0 0.0%
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1 0.3%
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1 0.2%
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Asian |
2 0.7%
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1 0.3%
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3 0.5%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
3 1.0%
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1 0.3%
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4 0.7%
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White |
281 98.3%
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282 98.6%
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563 98.4%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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1 0.3%
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1 0.2%
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Psoriasis Area and Severity Index (PASI) Score
[1] [2] Mean (Standard Deviation) Unit of measure: Units on a scale |
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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.
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Number of Participants with the Indicated Static Physician's Global Assessment (sPGA) Score
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 285 participants | 285 participants | 570 participants | |
Moderate |
170 59.6%
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182 63.9%
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352 61.8%
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Severe |
103 36.1%
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91 31.9%
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194 34.0%
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Very Severe |
12 4.2%
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12 4.2%
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24 4.2%
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Clear |
0 0.0%
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0 0.0%
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0 0.0%
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Almost Clear |
0 0.0%
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0 0.0%
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0 0.0%
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Mild |
0 0.0%
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0 0.0%
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0 0.0%
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[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
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |
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 |