MedTrace Logo

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

NCT02581345 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2018-10-17

Study results available
· View outcomes & findings →

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

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)

Sponsors & Collaborators

  • Momenta Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • John Caminis, MD · Shire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-04-04
Completion
2017-04-04

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • Estonia
  • Germany
  • Latvia
  • Poland
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02581345 on ClinicalTrials.gov