Home › Trials › NCT04951622

Evaluating Nipocalimab for Adults with Generalized Myasthenia Gravis

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Phase 3 Interventional Janssen Research & Development, LLC · NCT04951622

This study is testing a new drug called nipocalimab to see if it can help adults with generalized myasthenia gravis feel stronger and improve their daily activities compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment199 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsnipocalimab
Locations112 sites (Paradise Valley, Arizona and 111 other locations)
Trial IDNCT04951622 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of nipocalimab, an investigational drug, compared to a placebo in adults diagnosed with generalized myasthenia gravis (gMG). Participants will be evaluated based on their muscle weakness and daily living activities, with the goal of determining if nipocalimab can improve their condition. The study will involve administering the drug through infusion and monitoring participants for any adverse effects. It is designed as a Phase 3 interventional trial, indicating a focus on confirming effectiveness and safety in a larger population.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with generalized myasthenia gravis who exhibit moderate to severe muscle weakness.

Not a fit: Patients with mild myasthenia gravis or those who do not meet the specific clinical criteria for participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve muscle strength and daily functioning for patients with generalized myasthenia gravis.

How similar studies have performed: Previous studies have shown promise with similar approaches in treating myasthenia gravis, but the specific use of nipocalimab is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II a/b, III a/b, or IVa/b at screening
* Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (\>=) 6 at screening and baseline
* Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention
* For the SC Substudy (Cohort 1 and Cohort 2): Has reasonable abdominal skin area for SC administration
* For the SC Substudy (Cohort 1 and Cohort 2): Participants must be willing to comply with maintaining their stable dose of corticosteroids and/or immunosuppressants for the initial 8 weeks of the SC substudy, that is, through the SC Week 8 visit

Exclusion Criteria:

* Has 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
* Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and/or 'burnt out' MG)
* Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study
* Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
* Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening
* For the SC Substudy (Cohort 1): Participants who have undergone a recent tapering of their concomitant MG medication in the OLE
* For the SC Substudy (Cohort 1): Participants deteriorating during the OLE in the month prior to SC Dose 1 of the SC substudy such that they meet the criteria for clinical deterioration
* For the SC Substudy (Cohort 2): History of an unprovoked pulmonary embolism within 1 year prior to screening or history of recurrent deep vein thrombosis (DVT)

Where this trial is running

Paradise Valley, Arizona and 111 other locations

+62 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Myasthenia Gravis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.