Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05379634
The ClinicalTrials.gov registry entry for NCT05379634 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 257-participant average among 8 other Myositis trials with a reported enrollment target (86% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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
Similar trials for Myositis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.
RECRUITING · Phase 2
-
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
ACTIVE NOT RECRUITING · Phase 2
-
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
ACTIVE NOT RECRUITING · Phase 2
-
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
RECRUITING · Phase 1
-
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
RECRUITING · Phase 3
-
MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS)
RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.