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A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
NCT05379634 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05379634 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05379634?
The interventions under investigation include: Placebo (OTHER), Nipocalimab (DRUG), Glucocorticoids (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05379634?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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