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Recruiting Phase 3

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

NCT07217587 · tracked via the Priya Life Science Israel tracker
Phase
Phase 3
Started
2026-01-05
Last updated
2026-09-25

Condition(s) studied

Myasthenia Gravis

Investigational drug(s) / intervention(s)

Nipocalimab →Efgartigimod →

Nipocalimab: Nipocalimab will be administered intravenously.

Efgartigimod: Efgartigimod will be administered intravenously.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12 — Baseline, Weeks 8, 10 and 12
    Average mean percent change from baseline in total IgG levels over Weeks 8 , 10 and 12 will be reported.

Trial sites (19)

FacilityCityRegionStatus
Neurology Center of North Orange County Fullerton California Recruiting
The Neurology Group Pomona California Recruiting
Advanced Neurology of Colorado Fort Collins Colorado Completed
University of Connecticut Farmington Connecticut Recruiting
SFM Clinical Research LLC Boca Raton Florida Recruiting
HSHS St. Elizabeth's Hospital O'Fallon Illinois Recruiting
Josephson Wallack Munshower Neurology, PC Indianapolis Indiana Recruiting
Tulane Center for Clinical Research New Orleans Louisiana Recruiting
Neurology Center Of New England PC Foxborough Massachusetts Recruiting
Henry Ford Hospital Detroit Michigan Recruiting
Equity Medical New York New York Recruiting
Velocity Clinical Research, Inc. Raleigh North Carolina Recruiting
Atrium Health Wake Forest Baptist Winston-Salem North Carolina Recruiting
Neurology Clinic, PC Cordova Tennessee Recruiting
Austin Neuromuscular Center Austin Texas Recruiting
Texas Neurology Dallas Texas Recruiting
Rambam Medical Center Haifa Israel Recruiting
Sourasky Medical Center Tel Aviv Israel Recruiting
HOCH Health Ostschweiz Kantonsspital St.Gallen Sankt Gallen Switzerland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07217587 on ClinicalTrials.gov ↗ ← All trials in Israel