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A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
NCT04951622 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic \[PD\]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nipocalimab
- DRUG Nipocalimab SC-LIV
Study Locations (20)
Florida
- FM Clinical Research, LLC South Florida Neurology Associates, P. A. — Boca Raton
- University of Florida Health Jacksonville — Jacksonville
- Medsol Clinical Research Center Inc — Port Charlotte
- University of South Florida — Tampa
California
- University of Southern California — Los Angeles
- Stanford University — Palo Alto
- Care Access Research — Pasadena
Ohio
- University of Cincinnati — Cincinnati
- Cleveland Clinic — Cleveland
- The Ohio State University — Columbus
Arizona
- Neuromuscular Research Center and Clinic — Paradise Valley
- HonorHealth Neurology — Scottsdale
Massachusetts
- St. Elizabeth Medical Center — Boston
- Lahey Hospital & Medical Center — Burlington
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
Connecticut
- Yale New Haven Hospital — New Haven
Georgia
- Augusta University — Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2021-07-15 |
| Est. Completion | 2029-03-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04951622
The ClinicalTrials.gov registry entry for NCT04951622 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 199 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 Myasthenia Gravis 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: NCT04951622 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Ohio. 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 NCT04951622 about?
NCT04951622 is a clinical study titled "A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis". The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic \[PD\]) when given as an injection unde...
What is the current status of trial NCT04951622?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 199 participants. The study started on 2021-07-15. Estimated completion is 2029-03-30.
What conditions does trial NCT04951622 study?
This clinical trial studies the following conditions: Myasthenia Gravis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04951622?
The interventions under investigation include: Placebo (DRUG), Nipocalimab (DRUG), Nipocalimab SC-LIV (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04951622?
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 NCT04951622 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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