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NCT04951622 · ClinicalTrials.gov registry record · Phase 3
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
A Phase 3 study of Myasthenia Gravis, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 199
- Enrollment target
- 20
- Study locations
NCT04951622: Recruiting Phase 3 study of Myasthenia Gravis, sponsored by Janssen Research & Development.
NCT04951622 is a Phase 3 study of Myasthenia Gravis that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 199 participants, roughly in line with the 185-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target. The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04951622, a Phase 3 study of Myasthenia Gravis, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 199 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Average change from baseline over multiple timepoints (Weeks 22, 23, and 24) was reported in this outcome measure. The MG-ADL provided a rapid assessment of the participant's MG symptom severity of eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) rated on a 4-point scale ranging from 0 (normal) to 3 (severe). MG-ADL total score was sum of 8 individual items, which
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 |
What NCT04951622 shows while recruiting
NCT04951622 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 185-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target.
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.
NCT04951622 names 20 study sites across 11 states, led by Florida, California, Ohio.
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.
What interventions are being tested in trial NCT04951622?
The interventions under investigation include: Placebo (DRUG), Nipocalimab (DRUG), Nipocalimab SC-LIV (DRUG).
Who is sponsoring clinical trial NCT04951622?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04951622's enrollment target sits among peer trials
199 10th of 32 higher than 23 of 32 other Myasthenia Gravis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myasthenia Gravis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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