ACTIVE_NOT_RECRUITING

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 U.S. 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.

Official Title

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Quick Facts

Study Start:2021-07-15

Study Completion:2026-04-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04951622

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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): Has reasonable abdominal skin area for SC administration * For the SC Substudy (Cohort 1): 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	* 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 actively deteriorating at the SC Dose 1 visit for the SC substudy such that they meet the criteria for Clinical Deterioration

Inclusion Criteria

Exclusion 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): Has reasonable abdominal skin area for SC administration
* For the SC Substudy (Cohort 1): 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

* 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 actively deteriorating at the SC Dose 1 visit for the SC substudy such that they meet the criteria for Clinical Deterioration

Contacts and Locations

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

STUDY_DIRECTOR

Janssen Research & Development, LLC

Study Locations (Sites)

Neuromuscular Research Center and Clinic

Paradise Valley, Arizona, 85028

United States

HonorHealth Neurology

Scottsdale, Arizona, 85251

United States

University of Southern California

Los Angeles, California, 90033

United States

Stanford University

Palo Alto, California, 94304

United States

Care Access Research

Pasadena, California, 91101

United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Yale New Haven Hospital

New Haven, Connecticut, 06519

United States

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

Boca Raton, Florida, 33487

United States

University of Florida Health Jacksonville

Jacksonville, Florida, 32209

United States

Medsol Clinical Research Center Inc

Port Charlotte, Florida, 33952

United States

University of South Florida

Tampa, Florida, 33612

United States

Augusta University

Augusta, Georgia, 30912-3125

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

St. Elizabeth Medical Center

Boston, Massachusetts, 02135

United States

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805

United States

Washington University School Of Medicine

St Louis, Missouri, 63110

United States

Duke University School of Medicine

Durham, North Carolina, 27710

United States

University of Cincinnati

Cincinnati, Ohio, 45219

United States

Cleveland Clinic

Cleveland, Ohio, 44145

United States

The Ohio State University

Columbus, Ohio, 43210

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Wesley Neurology

Cordova, Tennessee, 38018

United States

UT Southwestern Medical Center

Dallas, Texas, 75390

United States

University of Vermont

Burlington, Vermont, 05401

United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-15

Study Completion Date2026-04-17

Study Record Updates

Study Start Date2021-07-15

Study Completion Date2026-04-17

Terms related to this study

Additional Relevant MeSH Terms

Myasthenia Gravis