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NCT05379634 · ClinicalTrials.gov registry record · Phase 2
A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
A Phase 2 study of Myositis, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 20
- Study locations
NCT05379634: Active Phase 2 study of Myositis, sponsored by Janssen Research & Development.
NCT05379634 is a Phase 2 study of Myositis that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 36 participants, below the 257-participant average among 8 other Myositis trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05379634, a Phase 2 study of Myositis, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
Primary Outcome
Percentage of participants who achieve at least minimal improvement (\>=20) in IMACS TIS at Week 52 and on \<=5 mg/day of oral prednisone (or equivalent) from Week 44 through Week 52 will be reported. International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with idiopathic inflammatory myopathies (IIM). Minimal improvement is defined as I
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Nipocalimab
- DRUG Glucocorticoids
Study Locations (20)
California
- Attune Health Autoimmune and Inflamation Care and Research - Beverly Hills
- University of California Irvine Medical Center - Orange
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
Florida
- FM Clinical Research, LLC South Florida Neurology Associates, P. A. - Boca Raton
- Integral Rheumatology And Immunology Specialists - Plantation
- University of South Florida - Tampa
Arizona
- Arizona Arthritis and Rheumatology Research PLLC - Phoenix
- HonorHealth Neurology - Scottsdale
Texas
- Nervie and Muscle Center of Texas - Houston
- University of Texas at Houston Medical School - Houston
Georgia
- Augusta University - Augusta
Kansas
- University of Kansas Medical Center - Kansas City
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- The Brigham and Women's Hospital, Inc. - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-07-05 |
| Est. Completion | 2026-09-16 |
| Phase | Phase 2 |
What the registry record for NCT05379634 still lists
NCT05379634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 257-participant average among 8 other Myositis trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Myositis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05379634 names 20 study sites across 14 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05379634 about?
NCT05379634 is a clinical study titled "A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies". The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
What is the current status of trial NCT05379634?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2022-07-05. Estimated completion is 2026-09-16.
What conditions does trial NCT05379634 study?
This clinical trial studies the following conditions: Myositis.
What interventions are being tested in trial NCT05379634?
The interventions under investigation include: Placebo (OTHER), Nipocalimab (DRUG), Glucocorticoids (DRUG).
Who is sponsoring clinical trial NCT05379634?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05379634 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05379634's enrollment target sits among peer trials
36 7th of 8 higher than 2 of 8 other Myositis trials
participants (enrollment target), bucketed by value
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