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NCT07217587Recruiting

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

Official recordSimplified version

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).

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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 3
Study type
Interventional
Countries
Switzerland, United States, Israel
Sponsor
Janssen Research & Development, LLC(Industry)
Protocol no.
80202135MYG3002
Conditions
Myasthenia Gravis
Interventions
Drug

Treatments studied

  • Nipocalimab
  • Efgartigimod

Locations · 18

  • Sankt Gallen, SwitzerlandHOCH Health Ostschweiz Kantonsspital St.GallenRecruiting at this site
  • Fullerton, United StatesNeurology Center of North Orange CountyRecruiting at this site
  • Pomona, United StatesThe Neurology GroupRecruiting at this site
  • Farmington, United StatesUniversity of ConnecticutRecruiting at this site
  • Boca Raton, United StatesSFM Clinical Research LLCRecruiting at this site
  • O'Fallon, United StatesHSHS St. Elizabeth's HospitalRecruiting at this site
  • Indianapolis, United StatesJosephson Wallack Munshower Neurology, PCRecruiting at this site
  • New Orleans, United StatesTulane Center for Clinical ResearchRecruiting at this site
  • Foxborough, United StatesNeurology Center Of New England PCRecruiting at this site
  • Detroit, United StatesHenry Ford HospitalRecruiting at this site
  • New York, United StatesEquity MedicalRecruiting at this site
  • Raleigh, United StatesVelocity Clinical Research, Inc.Recruiting at this site
  • Winston-Salem, United StatesAtrium Health Wake Forest BaptistRecruiting at this site
  • Cordova, United StatesNeurology Clinic, PCRecruiting at this site
  • Austin, United StatesAustin Neuromuscular CenterRecruiting at this site
  • Dallas, United StatesTexas NeurologyRecruiting at this site
  • Haifa, IsraelRambam Medical CenterRecruiting at this site
  • Tel Aviv, IsraelSourasky Medical CenterRecruiting at this site

In total, worldwide, 18 of the 19 sites listed in the registry are recruiting; the other one is not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: September 25, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

Other identifiers

  • 80202135MYG3002 · other identifier
  • 2025-521130-28-00 · other registry
  • 2025 · NIH grant

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.