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Nipocalimab and Efgartigimod for Generalized Myasthenia Gravis

This study is comparing two medications, nipocalimab and efgartigimod, to see how well they work for people with generalized myasthenia gravis (gMG). gMG is a condition where your body's immune system mistakenly attacks the connections between your nerves and muscles, causing muscle weakness. Both nipocalimab and efgartigimod are given through an IV. The main goal is to see how much these drugs change the levels of a specific antibody (Total Immunoglobulin G, or IgG) in your body over 12 weeks. You may be able to join if you are between 18 and 74 years old, have a diagnosis of gMG, and are otherwise medically stable. The current status of this study is unclear, and it plans to enroll 115 participants.

Study design
This interventional study is comparing two different medications. It plans to enroll 115 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured up to 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07217587

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

Recruiting
PHASE3Ages 18–74InterventionalTreatment
Janssen Research & Development, LLC
~115 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:NipocalimabEfgartigimod

At a glance

Recruiting sites
16 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12
Measured over Baseline, Weeks 8, 10 and 12

Conditions

Myasthenia Gravis

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Myasthenia GravisAcetylcholine Receptor

Where it's being run

17 sites across 14 states
California2
North Carolina2
Israel2
Colorado1
Connecticut1
Florida1
Illinois1
Indiana1

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

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

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