Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
NCT ID: NCT07217587
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
115 participants
INTERVENTIONAL
2026-01-05
2028-09-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Nipocalimab
Participants will receive nipocalimab intravenously (IV), at a loading dose on Day 1 followed by maintenance dosing once every 2 weeks (q2w) until Week 12.
Nipocalimab
Nipocalimab will be administered intravenously.
Arm 2: Efgartigimod
Participants will receive efgartigimod IV, once a week for 4 weeks starting from Day 1. Eligible participants will be given the option to switch to Arm 3 between Week 4 and Week 12.
Efgartigimod
Efgartigimod will be administered intravenously.
Arm 3: Treatment Switch (Nipocalimab)
Participants previously treated with efgartigimod, who are directly enrolled in this arm, and eligible participants switching from Arm 2 will receive nipocalimab IV at a loading dose on Switch Day 1 followed by maintenance dosing q2w until Switch Week 12.
Nipocalimab
Nipocalimab will be administered intravenously.
Interventions
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Nipocalimab
Nipocalimab will be administered intravenously.
Efgartigimod
Efgartigimod will be administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
74 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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SFM Clinical Research LLC
Boca Raton, Florida, United States
HSHS St. Elizabeth's Hospital
O'Fallon, Illinois, United States
Henry Ford Hospital
Detroit, Michigan, United States
Rambam Medical Center
Haifa, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Other Identifiers
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80202135MYG3002
Identifier Type: OTHER
Identifier Source: secondary_id
2025-521130-28-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
80202135MYG3002
Identifier Type: -
Identifier Source: org_study_id
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