A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Description

The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG).

Conditions

Myasthenia Gravis

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Study Overview

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Study Details

Study overview

The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG).

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

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Condition
Myasthenia Gravis
Intervention / Treatment

-

Contacts and Locations

Paradise Valley

Neuromuscular Research Center and Clinic, Paradise Valley, Arizona, United States, 85028

Scottsdale

HonorHealth Neurology, Scottsdale, Arizona, United States, 85251

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Pasadena

Care Access Research, Pasadena, California, United States, 91101

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

New Haven

Yale New Haven Hospital, New Haven, Connecticut, United States, 06519

Boca Raton

FM Clinical Research, LLC South Florida Neurology Associates, P. A., Boca Raton, Florida, United States, 33487

Jacksonville

University of Florida Health Jacksonville, Jacksonville, Florida, United States, 32209

Port Charlotte

Medsol Clinical Research Center Inc, Port Charlotte, Florida, United States, 33952

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II a/b, III a/b, or IVa/b at screening
  • * Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (\>=) 6 at screening and baseline
  • * Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
  • * A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention
  • * A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention
  • * Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
  • * Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and/or 'burnt out' MG)
  • * Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study
  • * Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
  • * Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2026-04-17