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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