Recruiting

Phase 3

NipocalimabA Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Sponsor:

Janssen Research & Development, LLC

Code:

NCT04951622

Conditions

Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nipocalimab

Placebo

Nipocalimab SC-LIV

Study Details

Brief 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.

Conditions

Myasthenia Gravis

Study ID

NCT04951622

Start date

Jul 15, 2021

Status verified date

Jul, 2026

Completion date

Mar 29, 2029

Anticipated

Primary completion date

Nov 17, 2023

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

199 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nipocalimab

Double-blind Placebo-controlled Phase: Participants will receive nipocalimab intravenous (IV) infusions once every 2 weeks (q2w) up to 24 weeks during double-blind placebo-controlled phase.

Open-label Extension (OLE) Phase: Participants who complete the double-blind placebo-controlled phase will enter the OLE phase and will have the option to continue to receive nipocalimab q2w IV infusion till study end or enter the nipocalimab SC substudy.

placebo comparator: Placebo

Double-blind Placebo-controlled Phase: Participants will receive matching placebo of nipocalimab IV infusion q2w up to 24 weeks during double-blind placebo-controlled phase.

experimental: Nipocalimab Subcutaneous (SC)

OLE Phase: Participants from Cohort 1 will receive nipocalimab subcutaneous liquid in vial (SC-LIV) qw until Week 8. Participants with gMG from Cohort 2 who have not received nipocalimab previously, will receive nipocalimab SC-LIV until Week 8. Participants who complete the 8-week treatment period will have the opportunity to continue receiving nipocalimab SC-LIV qw in the Long term extension (LTE) period.

Interventions

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.

Primary outcome measure

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 [ Time Frame: Baseline, Weeks 22, 23, and 24 ]
Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) [ Time Frame: 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) [ Time Frame: From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57) ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210 Participate-In-This-Study1@its.jnj.com

Locations

Neuromuscular Research Center and Clinic

Recruiting

Paradise Valley, Arizona, United States, 85028

Care Access Research

Recruiting

Pasadena, California, United States, 91101

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06519

FM Clinical Research, LLC South Florida Neurology Associates, P. A.

Recruiting

Boca Raton, Florida, United States, 33487

Medsol Clinical Research Center Inc

Recruiting

Port Charlotte, Florida, United States, 33952

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Duke University School of Medicine

Recruiting

Durham, North Carolina, United States, 27710

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44145

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

The Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-07-27.