Nipocalimab versus efgartigimod for generalized myasthenia gravis

Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab

This trial will test whether nipocalimab or efgartigimod works better to reduce muscle weakness in adults with AChR-positive generalized myasthenia gravis who have meaningful symptoms despite stable therapy.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 115 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: Janssen Research & Development, LLC (industry)
• Drugs / interventions: eculizumab, nipocalimab
• Locations: 12 sites (Pomona, California and 11 other locations)
• Trial ID: NCT07217587 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized head-to-head comparison enrolls adults with AChR-antibody positive generalized myasthenia gravis (MGFA class II–IV) and an MG-ADL score >= 5. Eligible participants are medically stable and may have a suboptimal response to current therapies or have discontinued certain immunosuppressants. Participants are assigned to receive either nipocalimab or efgartigimod and are followed for changes in muscle strength and daily functioning. The study is conducted at regional neurology centers in the United States.

Who should consider this trial

Good fit: Adults with generalized, AChR-antibody positive myasthenia gravis (MGFA class II–IV) who are medically stable, have MG-ADL >= 5 with less than half the score from ocular symptoms, and can attend visits at a participating U.S. site.

Not a fit: People without AChR antibodies, those with primarily ocular MG, or those unable to travel to the listed U.S. sites are unlikely to be eligible or to benefit from this comparison.

Why it matters

Potential benefit: If one drug proves superior, patients could get clearer guidance on which therapy reduces weakness faster or more substantially and improves daily function.

How similar studies have performed: Efgartigimod is already approved for gMG and FcRn-targeting approaches have shown clinical benefit, but direct head-to-head comparisons remain limited.

Eligibility 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

Where this trial is running

Pomona, California and 11 other locations

• The Neurology Group — Pomona, California, United States (RECRUITING)
• Advanced Neurology of Colorado — Fort Collins, Colorado, United States (RECRUITING)
• University of Connecticut — Farmington, Connecticut, United States (RECRUITING)
• SFM Clinical Research LLC — Boca Raton, Florida, United States (RECRUITING)
• HSHS St. Elizabeth's Hospital — O'Fallon, Illinois, United States (RECRUITING)
• Henry Ford Hospital — Detroit, Michigan, United States (RECRUITING)
• Velocity Clinical Research, Inc. — Raleigh, North Carolina, United States (RECRUITING)
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (RECRUITING)
• Texas Neurology — Dallas, Texas, United States (RECRUITING)
• Rambam Medical Center — Haifa, Israel (RECRUITING)
• Sourasky Medical Center — Tel Aviv, Israel (RECRUITING)
• HOCH Health Ostschweiz Kantonsspital St.Gallen — Sankt Gallen, Switzerland (RECRUITING)

Study contacts

• Study coordinator: Study Contact

Conditions: Myasthenia Gravis