Recruiting
Phase 3

Nipocalimab vs. Efgartigimod

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07217587

Conditions

Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Nipocalimab

Efgartigimod

Study Details

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 attacks and damages the connection between nerves and muscles causing muscle weakness).

Conditions

Myasthenia Gravis

Study ID

NCT07217587

Start date

Jan 5, 2026

Status verified date

Aug, 2026

Completion date

Jan 29, 2029

Anticipated

Primary completion date

Sep 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

115 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Nipocalimab

Nipocalimab will be administered intravenously.

Efgartigimod

Efgartigimod will be administered intravenously.

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 and Locations

Locations

Neurology Center of North Orange County

Recruiting

Fullerton, California, United States, 92835

The Neurology Group

Recruiting

Pomona, California, United States, 91767

University of Connecticut

Recruiting

Farmington, Connecticut, United States, 06030

SFM Clinical Research LLC

Recruiting

Boca Raton, Florida, United States, 33487

HSHS St. Elizabeth's Hospital

Recruiting

O'Fallon, Illinois, United States, 62269

Josephson Wallack Munshower Neurology, PC

Recruiting

Indianapolis, Indiana, United States, 46256

Tulane Center for Clinical Research

Recruiting

New Orleans, Louisiana, United States, 70112

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Equity Medical

Recruiting

New York, New York, United States, 10023

Velocity Clinical Research, Inc.

Recruiting

Raleigh, North Carolina, United States, 27607 6010

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Neurology Clinic, PC

Recruiting

Cordova, Tennessee, United States, 38018

Texas Neurology

Recruiting

Dallas, Texas, United States, 75206

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.