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A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

NCT04951622 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2026-03-03

Study results available
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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

Interventions

DRUG

Placebo

Matching placebo will be administered as an IV infusion.

DRUG

Nipocalimab SC-LIV

Nipocalimab will be administered subcutaneously.

DRUG

Nipocalimab

Nipocalimab will be administered as an IV infusion.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2023-11-17
Completion
2029-03-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Mexico
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04951622 on ClinicalTrials.gov