A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Myasthenia Gravis

In brief

The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic \[PD\]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG.

Key facts

Study ID

NCT04951622

Run by

Janssen Research & Development, LLC

People needed

199

Starts

2021-07-15

Expected to finish

2029-03-29

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• The Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (enrolling)
• The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine — Guangzhou, China (enrolling)
• AZ Sint Jan Brugge Oostende AV — Bruges, Belgium (enrolling)
• University Hospitals Leuven — Leuven, Belgium (enrolling)
• Beijing Hospital — Beijing, China (enrolling)
• Xiangya Hospital Central South University — Changsha, China (enrolling)
• Gold Coast University Hospital — Southport, Australia (enrolling)
• ULB Hôpital Erasme — Anderlecht, Belgium (enrolling)
• Care Access Research — Pasadena, California, United States (enrolling)
• AZ Sint-Lucas — Ghent, Belgium (enrolling)
• Beijing Tiantan Hospital, Capital Medical University — Beijing, China (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• The First Bethune Hospital of Jilin University — Changchun, China (enrolling)
• FM Clinical Research, LLC South Florida Neurology Associates, P. A. — Boca Raton, Florida, United States (enrolling)
• Duke University School of Medicine — Durham, North Carolina, United States (enrolling)
• Neuromuscular Research Center and Clinic — Paradise Valley, Arizona, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Medsol Clinical Research Center Inc — Port Charlotte, Florida, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Cliniques Universitaires Saint Luc — Brussels, Belgium (enrolling)
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• Toronto General Hospital — Toronto, Ontario, Canada (enrolling)
• Qianfoshan hospital of Shandong Province — Jinan, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.