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

Recruiting now · Phase 3

Conditions studied: Myasthenia Gravis

In brief

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).

Key facts

Study ID

NCT07217587

Run by

Janssen Research & Development, LLC

People needed

115

Starts

2026-01-05

Expected to finish

2029-01-29

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Neurology Center of North Orange County — Fullerton, California, United States (enrolling)
• The Neurology Group — Pomona, California, United States (enrolling)
• Advanced Neurology of Colorado — Fort Collins, Colorado, United States (enrolling)
• University of Connecticut — Farmington, Connecticut, United States (enrolling)
• SFM Clinical Research LLC — Boca Raton, Florida, United States (enrolling)
• HSHS St. Elizabeth's Hospital — O'Fallon, Illinois, United States (enrolling)
• Josephson Wallack Munshower Neurology, PC — Indianapolis, Indiana, United States (enrolling)
• Tulane Center for Clinical Research — New Orleans, Louisiana, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Equity Medical — New York, New York, United States (enrolling)
• Velocity Clinical Research, Inc. — Raleigh, North Carolina, United States (enrolling)
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (enrolling)
• Neurology Clinic, PC — Cordova, Tennessee, United States (enrolling)
• Texas Neurology — Dallas, Texas, United States (enrolling)
• Rambam Medical Center — Haifa, Israel (enrolling)
• Sourasky Medical Center — Tel Aviv, Israel (enrolling)
• HOCH Health Ostschweiz Kantonsspital St.Gallen — Sankt Gallen, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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