Status:
RECRUITING
Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Myasthenia Gravis
Eligibility:
All Genders
18-74 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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 local label
- 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
Exclusion
Key Trial Info
Start Date :
November 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 4 2028
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT07217587
Start Date
November 28 2025
End Date
September 4 2028
Last Update
December 5 2025
Active Locations (2)
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1
SFM Clinical Research LLC
Boca Raton, Florida, United States, 33487
2
HSHS St. Elizabeth's Hospital
O'Fallon, Illinois, United States, 62269