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Clinical Trials in the USA / NCT04951622
Recruiting Phase 3

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

NCT04951622 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2021-07-15
Last updated
2026-07-27

Condition(s) studied

Myasthenia Gravis

Investigational drug(s) / intervention(s)

Nipocalimab →PlaceboNipocalimab SC-LIV

Nipocalimab: Nipocalimab will be administered as an IV infusion.

Placebo: Matching placebo will be administered as an IV infusion.

Nipocalimab SC-LIV: Nipocalimab will be administered subcutaneously.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (112)

FacilityCityRegionStatus
Neuromuscular Research Center and Clinic Paradise Valley Arizona Recruiting
HonorHealth Neurology Scottsdale Arizona Completed
University of Southern California Los Angeles California Completed
Stanford University Palo Alto California Completed
Care Access Research Pasadena California Recruiting
University of Colorado Anschutz Medical Campus Aurora Colorado Recruiting
Yale New Haven Hospital New Haven Connecticut Recruiting
FM Clinical Research, LLC South Florida Neurology Associates, P. A. Boca Raton Florida Recruiting
University of Florida Health Jacksonville Jacksonville Florida Completed
Medsol Clinical Research Center Inc Port Charlotte Florida Recruiting
University of South Florida Tampa Florida Recruiting
Augusta University Augusta Georgia Completed
University of Kansas Medical Center Kansas City Kansas Recruiting
St. Elizabeth Medical Center Boston Massachusetts Completed
Lahey Hospital & Medical Center Burlington Massachusetts Completed
Washington University School Of Medicine St Louis Missouri Completed
Duke University School of Medicine Durham North Carolina Recruiting
University of Cincinnati Cincinnati Ohio Completed
Cleveland Clinic Cleveland Ohio Recruiting
The Ohio State University Columbus Ohio Completed
Medical University of South Carolina Charleston South Carolina Recruiting
Wesley Neurology Cordova Tennessee Completed
UT Southwestern Medical Center Dallas Texas Completed
University of Vermont Burlington Vermont Completed
Melbourne Neurology Group North Melbourne Australia Completed
Gold Coast University Hospital Southport Australia Recruiting
ULB Hôpital Erasme Anderlecht Belgium Recruiting
AZ Sint Jan Brugge Oostende AV Bruges Belgium Recruiting
Cliniques Universitaires Saint Luc Brussels Belgium Recruiting
AZ Sint-Lucas Ghent Belgium Recruiting
University Hospitals Leuven Leuven Belgium Recruiting
The Ottawa Hospital Research Institute Ottawa Ontario Recruiting
Toronto General Hospital Toronto Ontario Recruiting
McGill University Montreal Quebec Completed
Beijing Tiantan Hospital, Capital Medical University Beijing China Recruiting
Xuanwu Hospital ,Capital Medical University Beijing China Completed
Beijing Hospital Beijing China Recruiting
The First Bethune Hospital of Jilin University Changchun China Recruiting
Xiangya Hospital Central South University Changsha China Recruiting
West China Hospital of Sichuan University Chengdu China Completed

+ 72 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04951622 on ClinicalTrials.gov ↗ ← All trials in the USA