A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

ClinicalTrials.gov ID: NCT04951622

Public ClinicalTrials.gov record NCT04951622. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 7, 2026, 3:31 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04951622
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Janssen Research & Development, LLC; Industry
Enrollment: 199 participants

Conditions and interventions

Conditions

Myasthenia Gravis

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 14, 2021
Primary completion: Nov 16, 2023
Completion: Mar 28, 2029
Last update posted: Jul 26, 2026

2021 – 2029

United States locations

U.S. sites: 24
U.S. states: 15
U.S. cities: 24

Facility	City	State	ZIP	Site status
Neuromuscular Research Center and Clinic	Paradise Valley	Arizona	85028	Recruiting
HonorHealth Neurology	Scottsdale	Arizona	85251	Completed
University of Southern California	Los Angeles	California	90033	Completed
Stanford University	Palo Alto	California	94304	Completed
Care Access Research	Pasadena	California	91101	Recruiting
University of Colorado Anschutz Medical Campus	Aurora	Colorado	80045	Recruiting
Yale New Haven Hospital	New Haven	Connecticut	06519	Recruiting
FM Clinical Research, LLC South Florida Neurology Associates, P. A.	Boca Raton	Florida	33487	Recruiting
University of Florida Health Jacksonville	Jacksonville	Florida	32209	Completed
Medsol Clinical Research Center Inc	Port Charlotte	Florida	33952	Recruiting
University of South Florida	Tampa	Florida	33612	Recruiting
Augusta University	Augusta	Georgia	30912-3125	Completed
University of Kansas Medical Center	Kansas City	Kansas	66160	Recruiting
St. Elizabeth Medical Center	Boston	Massachusetts	02135	Completed
Lahey Hospital & Medical Center	Burlington	Massachusetts	01805	Completed
Washington University School Of Medicine	St Louis	Missouri	63110	Completed
Duke University School of Medicine	Durham	North Carolina	27710	Recruiting
University of Cincinnati	Cincinnati	Ohio	45219	Completed
Cleveland Clinic	Cleveland	Ohio	44145	Recruiting
The Ohio State University	Columbus	Ohio	43210	Completed
Medical University of South Carolina	Charleston	South Carolina	29425	Recruiting
Wesley Neurology	Cordova	Tennessee	38018	Completed
UT Southwestern Medical Center	Dallas	Texas	75390	Completed
University of Vermont	Burlington	Vermont	05401	Completed

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 88 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04951622, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 26, 2026 · Synced Sep 7, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04951622 live on ClinicalTrials.gov.

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