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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3

Conditions: Myasthenia Gravis

Treatments: Drug: Efgartigimod; Drug: Nipocalimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07217587

80202135MYG3002 (Other Identifier)

2025-521130-28-00 (Registry Identifier)

Details and patient eligibility

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).

Enrollment: 115 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 3 patient groups

Arm 1: Nipocalimab

Experimental group

Description:

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.

Treatment:

Drug: Nipocalimab

Arm 2: Efgartigimod

Active Comparator group

Description:

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.

Treatment:

Drug: Efgartigimod

Arm 3: Treatment Switch (Nipocalimab)

Experimental group

Description:

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.

Treatment:

Drug: Nipocalimab