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

NCT07217587 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: 80202135MYG30022025-521130-28-00
• Study Type: interventional
• Target: 115
• Locations: 2 countries
• Sites: 8

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

Outcome Measures

Primary Outcomes (1)

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

  Average mean percent change from baseline in total IgG levels over Weeks 8 , 10 and 12 will be reported.

  Baseline, Weeks 8, 10 and 12

Secondary Outcomes (20)

• Arms 1 and 2: Averaged Mean Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score Over Weeks 8, 10 and 12

  Baseline, Weeks 8, 10 and 12

• Arms 1 and 2: Mean Percent Change from Baseline in Total IgG Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation

  Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12

• Arms 1 and 2: Mean Percent Change from Baseline in MG-ADL Total Score Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation

  Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12

• Arms 1 and 2: Mean Percent Change from Baseline in Total IgG Levels at Week 8

  Baseline and Week 8

• Arms 1 and 2: Mean Change from Baseline in MG-ADL Total Score at Week 8

  Baseline and Week 8

Study Arms (3)

Arm 1: Nipocalimab

EXPERIMENTAL

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.

Drug: Nipocalimab

Arm 2: Efgartigimod

ACTIVE COMPARATOR

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.

Drug: Efgartigimod

Arm 3: Treatment Switch (Nipocalimab)

EXPERIMENTAL

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.

Drug: Nipocalimab

Interventions

Nipocalimab DRUG

Nipocalimab will be administered intravenously.

Also known as: JNJ-80202135, JNJ-86507083

Arm 1: Nipocalimab; Arm 3: Treatment Switch (Nipocalimab)

Efgartigimod DRUG

Efgartigimod will be administered intravenously.

Arm 2: Efgartigimod

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (8)

University of Connecticut

Farmington, Connecticut, 06030, United States

RECRUITING

SFM Clinical Research LLC

Boca Raton, Florida, 33487, United States

RECRUITING

HSHS St. Elizabeth's Hospital

O'Fallon, Illinois, 62269, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Texas Neurology

Dallas, Texas, 75206, United States

RECRUITING

Rambam Medical Center

Haifa, 3109601, Israel

RECRUITING

Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

efgartigimod alfa

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 16, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): September 28, 2027
• Study Completion (Estimated): December 11, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (6); IL (2)