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NCT07217587From ClinicalTrials.govRecruiting

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

Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab

  • Myasthenia Gravis

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
115
Started
5 January 2026
Main results due
28 September 2027
Study sites
19
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 74 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(19)

  • Neurology Center of North Orange County

    Fullerton, California, United States

    Recruiting

  • The Neurology Group

    Pomona, California, United States

    Recruiting

  • Advanced Neurology of Colorado

    Fort Collins, Colorado, United States

    Completed

  • University of Connecticut

    Farmington, Connecticut, United States

    Recruiting

  • SFM Clinical Research LLC

    Boca Raton, Florida, United States

    Recruiting

  • HSHS St. Elizabeth's Hospital

    O'Fallon, Illinois, United States

    Recruiting

  • Josephson Wallack Munshower Neurology, PC

    Indianapolis, Indiana, United States

    Recruiting

  • Tulane Center for Clinical Research

    New Orleans, Louisiana, United States

    Recruiting

  • Neurology Center Of New England PC

    Foxborough, Massachusetts, United States

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, United States

    Recruiting

  • Equity Medical

    New York, New York, United States

    Recruiting

  • Velocity Clinical Research, Inc.

    Raleigh, North Carolina, United States

    Recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, United States

    Recruiting

  • Neurology Clinic, PC

    Cordova, Tennessee, United States

    Recruiting

  • Austin Neuromuscular Center

    Austin, Texas, United States

    Recruiting

  • Texas Neurology

    Dallas, Texas, United States

    Recruiting

  • Rambam Medical Center

    Haifa, Israel

    Recruiting

  • Sourasky Medical Center

    Tel Aviv, Israel

    Recruiting

  • HOCH Health Ostschweiz Kantonsspital St.Gallen

    Sankt Gallen, Switzerland

    Recruiting

Showing 19 of 19 sites. 18 of the 19 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07217587. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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