At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 572 enrolled
Drug / intervention
M923 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating M923 and Humira for Chronic Plaque Psoriasis and Psoriasis. Completed, enrolled 572 participants across 90 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Plaque Psoriasis, Psoriasis
CountriesBulgaria, Canada, Czechia, Estonia, Germany, Latvia, Poland, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
First PostedOct 2015
Primary CompletionApr 2017
TodayJul 2026
First PostedOct 21, 2015
Enrollment StartSep 1, 2015
Primary CompletionApr 4, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.7 years ago
Interventions
M923biological
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
Humirabiological
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)