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NCT07217587PHASE3Recruiting

Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

Janssen Research & Development, LLC

Start Date

1/5/2026

Completion Date

1/29/2029

Summary

The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).

Eligibility Criteria

Age Range: 18 years to 74 years

Inclusion criteria: For all arms: * Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening * Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized MG (gMG) as defined by the Myasthenia gravis foundation of America (MGFA) clinical classification class II a/b, III a/b, or IV a/b at screening and positive for acetylcholine receptor (AChR) antibodies * Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of greater than or equal to (\>=) 5 with less than (\<) 50% of symptoms coming from ocular MG-ADL sub-scores at study screening and baseline (Day 1) visits Criteria specific to Arms 1 and 2 only: \- Has suboptimal response to current stable therapy for gMG according to the investigator or has discontinued corticosteroids and/or immunosuppressants/immunomodulators including eculizumab or other novel approved immune agents at least 4 weeks prior to baseline due to intolerance or lack of efficacy Criteria specific to Arm 3: \- Treatment with efgartigimod IV or subcutaneous (SC) for \>=1 cycle, and the final cycle is consistent with product information Exclusion criteria: * 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 * Had a thymectomy within 1 year prior to baseline, or thymectomy is planned during the study * Currently has a malignancy or has a history of malignancy within 3 years before baseline Criteria specific to Arms 1 and 2 only: \- Has received treatment for MG with an FcRn-targeting therapy Criteria specific to Arm 3 only: \- Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, with the exception of efgartigimod

Interventions

DRUG

Nipocalimab

DRUG

Efgartigimod

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Conditions

Myasthenia Gravis

Locations

Neurology Center of North Orange County

Fullerton, California 92835

United States

The Neurology Group

Pomona, California 91767

United States

Advanced Neurology of Colorado

Fort Collins, Colorado 80528

United States

University of Connecticut

Farmington, Connecticut 06030

United States

SFM Clinical Research LLC

Boca Raton, Florida 33487

United States

HSHS St. Elizabeth's Hospital

O'Fallon, Illinois 62269

United States

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana 46256

United States

Tulane Center for Clinical Research

New Orleans, Louisiana 70112

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

Equity Medical

New York, New York 10023

United States

Velocity Clinical Research, Inc.

Raleigh, North Carolina 27607 6010

United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina 27157

United States

Neurology Clinic, PC

Cordova, Tennessee 38018

United States

Texas Neurology

Dallas, Texas 75206

United States

Rambam Medical Center

Haifa, 3109601

Israel

Sourasky Medical Center

Tel Aviv, 6423906

Israel

HOCH Health Ostschweiz Kantonsspital St.Gallen

Sankt Gallen, 9007

Switzerland