Evaluating Nipocalimab for Adults with Generalized Myasthenia Gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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. Reminder that increasing the dose of existing MG therapy or starting new MG therapy anytime throughout study conduct is prohibited.
* 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 it's running

• Neuromuscular Research Center and Clinic
  Paradise Valley, Arizona, United States Recruiting
• Care Access Research
  Pasadena, California, United States Recruiting
• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• FM Clinical Research, LLC South Florida Neurology Associates, P. A.
  Boca Raton, Florida, United States Recruiting
• Medsol Clinical Research Center Inc
  Port Charlotte, Florida, United States Recruiting

+62 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nipocalimab versus efgartigimod for generalized myasthenia gravis

  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.

  Recruiting at 30 sites Phase 3 Janssen Research & Development, LLC · Fullerton, California and 30 other locations · NCT07217587

• Nipocalimab treatment for children with generalized myasthenia gravis

  This study is testing a new treatment called nipocalimab to see if it can help children with generalized myasthenia gravis who haven't responded well to other therapies.

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• MG patient registry to track long-term experiences and treatment patterns

  This registry collects information from adults with myasthenia gravis to see how symptoms and quality of life change over time and how treatments relate to those changes.

  Recruiting Autoimmune Neurology Alliance · Framingham, Massachusetts · NCT07761026

• Ublituximab maintenance after efgartigimod response in myasthenia gravis

  This study tests whether giving ublituximab as maintenance after a positive response to efgartigimod helps adults with myasthenia gravis.

  Recruiting at 7 sites Phase 2 TG Therapeutics, Inc. · Colorado Springs, Colorado and 6 other locations · NCT07673744

• Nipocalimab in breast milk after a single IV dose in healthy lactating women

  This study tests how much nipocalimab shows up in breast milk after a single IV dose in healthy breastfeeding women.

  Recruiting Phase 1 Janssen Research & Development, LLC · Salt Lake City, Utah · NCT07669077

• Pregnant Women with Neuroimmune Diseases: A long-term follow-up study

  This study follows women with neuroimmune diseases and healthy controls through pregnancy and up to ten years to see how pregnancy affects disease activity and outcomes for both mother and baby.

  Recruiting Third Affiliated Hospital, Sun Yat-Sen University · Guangzhou, Guangdong · NCT07653984

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.