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)
Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24 — Baseline, Weeks 22, 23, and 24 Average change from baseline over multiple timepoints (Weeks 22, 23, and 24) was reported in this outcome measure. The MG-ADL provided a rapid assessment of the participant's MG symptom severity of eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) rated on a 4-point scale ranging from 0 (normal) to 3 (severe). MG-ADL total score was sum of 8 individual items, which ranging from 0 to 24. A higher score indicated greater symptom severity. Baseline was defined as the average of the screening and Day 1 total scores.
Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) — From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)
Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) — From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)
Trial sites (112)
Facility
City
Region
Status
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
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.
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