Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
Janssen Research & Development, LLC · NCT07217587
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–74 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 115
- US sites recruiting
- 15
- Study start
- January 5, 2026
- Record last updated
- September 25, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: Nipocalimab; Efgartigimod
Conditions: Myasthenia Gravis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Neurology Center of North Orange County
Fullerton, CA 92835
The Neurology Group
Pomona, CA 91767
University of Connecticut
Farmington, CT 06030
SFM Clinical Research LLC
Boca Raton, FL 33487
HSHS St. Elizabeth's Hospital
O'Fallon, IL 62269
Josephson Wallack Munshower Neurology, PC
Indianapolis, IN 46256
Tulane Center for Clinical Research
New Orleans, LA 70112
Neurology Center Of New England PC
Foxborough, MA 02035
Henry Ford Hospital
Detroit, MI 48202
Equity Medical
New York, NY 10023
Velocity Clinical Research, Inc.
Raleigh, NC 27607 6010
Atrium Health Wake Forest Baptist
Winston-Salem, NC 27157
Neurology Clinic, PC
Cordova, TN 38018
Austin Neuromuscular Center
Austin, TX 78759
Texas Neurology
Dallas, TX 75206
Study contacts (from the official record)
- Study Contact · 844-434-4210 · Participate-In-This-Study1@its.jnj.com