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NCT02581345 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis
A Phase 3 study, sponsored by Momenta Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 572
- Enrollment target
NCT02581345: Completed Phase 3 study, sponsored by Momenta Pharmaceuticals.
NCT02581345 is a Phase 3 study that has completed, run by Momenta Pharmaceuticals. The registered enrollment target is 572 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02581345, a Phase 3 study, has completed, sponsored by Momenta Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 572 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (M923) and Humira in participants with moderate to severe chronic plaque-type psoriasis.
Primary Outcome
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 s
Interventions
- BIOLOGICAL M923
- BIOLOGICAL Humira
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 572 participants |
| Start Date | 2015-09 |
| Est. Completion | 2017-04-04 |
| Phase | Phase 3 |
What the finished NCT02581345 record still lists
NCT02581345 is an interventional study that assigns participants to a tested intervention. The registered 572 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which M923 is the first listed.
NCT02581345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02581345 about?
NCT02581345 is a clinical study titled "Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis". The purpose of the study is to evaluate efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (M923) and Humira in participants with moderate to severe chronic plaque-type psoriasis.
What is the current status of trial NCT02581345?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 572 participants. The study started on 2015-09. Estimated completion is 2017-04-04.
What interventions are being tested in trial NCT02581345?
The interventions under investigation include: M923 (BIOLOGICAL), Humira (BIOLOGICAL).
Who is sponsoring clinical trial NCT02581345?
This trial is sponsored by Momenta Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02581345's enrollment target sits among peer trials
572 663rd of 2000 higher than 1,336 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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