Trials / Completed
CompletedNCT02581345
Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis
A Phase 3 Randomized, Double-blind, Multicenter Study to Evaluate Efficacy, Safety, and Immunogenicity of an Adalimumab Biosimilar (M923) and Humira® in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 572 (actual)
- Sponsor
- Momenta Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | M923 | Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α) |
| BIOLOGICAL | Humira | Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α) |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2017-04-04
- Completion
- 2017-04-04
- First posted
- 2015-10-21
- Last updated
- 2018-10-17
- Results posted
- 2018-09-12
Locations
90 sites across 9 countries: United States, Bulgaria, Canada, Czechia, Estonia, Germany, Latvia, Poland, Slovakia
Source: ClinicalTrials.gov record NCT02581345. Inclusion in this directory is not an endorsement.