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

Part of paid clinical trials in Fullerton, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07217587
Phase
PHASE3
Status
Recruiting
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Conditions

  • Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Nipocalimab — DRUG
    Nipocalimab will be administered intravenously.
  • Efgartigimod — DRUG
    Efgartigimod will be administered intravenously.

Study Details

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).

Key Dates

Start date
Jan 5, 2026
Status verified
Jun 2026
Primary completion
Sep 28, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
115 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12 [ Time Frame: Baseline, Weeks 8, 10 and 12 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Neurology Center of North Orange CountyFullertonCalifornia92835-
The Neurology GroupPomonaCalifornia91767-
Advanced Neurology of ColoradoFort CollinsColorado80528-
University of ConnecticutFarmingtonConnecticut06030-
SFM Clinical Research LLCBoca RatonFlorida33487-
HSHS St. Elizabeth's HospitalO'FallonIllinois62269-
Josephson Wallack Munshower Neurology, PCIndianapolisIndiana46256-
Henry Ford HospitalDetroitMichigan48202-
Velocity Clinical Research, Inc.RaleighNorth Carolina27607 6010-
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157-
Texas NeurologyDallasTexas75206-

Find similar trials in Fullerton, CA

By research site
Neurology Center of North Orange County· Fullerton, CAThe Neurology Group· Pomona, CAAdvanced Neurology of Colorado· Fort Collins, COUniversity of Connecticut· Farmington, CTSFM Clinical Research LLC· Boca Raton, FLHSHS St. Elizabeth's Hospital· O'Fallon, IL

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