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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 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.

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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.

Conditions Studied

Myasthenia Gravis

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

FieldValue
Enrollment Target 199 participants
Start Date 2021-07-15
Est. Completion 2029-03-30
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

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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, categorized as Phase 3. The registered enrollment target is 199 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 185-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.