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NCT04951622PHASE3Recruiting

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Janssen Research & Development, LLC

Start Date

7/15/2021

Completion Date

3/29/2029

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 Criteria

Age Range: 18 years to No maximum

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)

Interventions

DRUG

Nipocalimab

DRUG

Placebo

DRUG

Nipocalimab SC-LIV

Interested in This Trial?

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Conditions

Myasthenia Gravis

Locations

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

Melbourne Neurology Group

North Melbourne, 3051

Australia

Gold Coast University Hospital

Southport, 4215

Australia

ULB Hôpital Erasme

Anderlecht, 1070

Belgium

AZ Sint Jan Brugge Oostende AV

Bruges, 8000

Belgium

Cliniques Universitaires Saint Luc

Brussels, 1200

Belgium

AZ Sint-Lucas

Ghent, 9000

Belgium

University Hospitals Leuven

Leuven, 3000

Belgium

The Ottawa Hospital Research Institute

Ottawa, Ontario K1Y 4E9

Canada

Toronto General Hospital

Toronto, Ontario M5G 2C4

Canada

McGill University

Montreal, Quebec H3A 2B4

Canada

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100050

China

Xuanwu Hospital ,Capital Medical University

Beijing, 100053

China

Beijing Hospital

Beijing, 100730

China

The First Bethune Hospital of Jilin University

Changchun, 130021

China

Xiangya Hospital Central South University

Changsha, 410008

China

West China Hospital of Sichuan University

Chengdu, 610041

China

Fujian Medical University Union Hospital

Fuzhou, 350001

China

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, 510405

China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310020

China

Qianfoshan hospital of Shandong Province

Jinan, 250014

China

Qilu Hospital of Shandong University

Jinan, 250014

China

Huashan Hospital Fudan University

Shanghai, 200040

China

Tianjin Medical University General Hospital

Tianjin, 300052

China

The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital

Xi'an, 710038

China

Neurologie a rehabilitace Skopalíkova

Brno, 615 00

Czechia

Fakultni nemocnice Brno

Brno, 625 00

Czechia

Vseobecna Fakultní Nemocnice

Prague, 12808

Czechia

Aalborg University Hospital

Aalborg, 9000

Denmark

Rigshospitalet

København Ø, 2100

Denmark

Hopital Pierre Wertheimer

Bron, 69500

France

CHU Grenoble

Grenoble, 38043

France

Hopital de la Pitie Salpetriere

Paris, 75013

France

Hopital Pasteur 1

Provence-Alpes-Côte d'Azur, 06000

France

Hopital PASTEUR

Provence-Alpes-Côte d'Azur, 06000

France

NeuroCure Clinical Research Center

Berlin, 10117

Germany

Universitatsmedizin Gottingen

Göttingen, 37075

Germany

Universitaetsklinikum Leipzig

Leipzig, 04103

Germany

Universitatsklinikum Schleswig Holstein Campus Lubeck

Lübeck, 23538

Germany

Universitatsklinikum Ulm

Ulm, 89081

Germany

DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie

Wiesbaden, 65191

Germany

U.O.P.I. di Psichiatria

Catania, 95100

Italy

Fondazione Istituto G. Giglio

Cefalù, 90015

Italy

Istituto Neurologico Carlo Besta

Milan, 20133

Italy

Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli

Naples, 80138

Italy

IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione

Pavia, 27100

Italy

Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza

Roma, 00189

Italy

Policlinico Universitario Agostino Gemelli

Roma, 168

Italy

Chiba University Hospital

Chiba, 260 8677

Japan

General Hanamaki Hospital

Hanamaki, 025-0082

Japan

Hiroshima University Hospital

Hiroshima, 734 8551

Japan

Teikyo University Hospital

Itabashi Ku, 173 8606

Japan

St Marianna University Hospital

Kawasaki Shi, 216 8511

Japan

Kagawa University Hospital

Kita Gun, 761 0793

Japan

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

National Hospital Organization Nagoya Medical Center

Nagoya, 460-0001

Japan

Niigata City General Hospital

Niigata, 950-1197

Japan

Hyogo College of Medicine Hospital

Nishinomiya-Shi, 663-8501

Japan

Sapporo Medical University Hospital

Sapporo, 0608556

Japan

Hokkaido Medical Center

Sapporo, 063 0005

Japan

National Hospital Organization Sendai Medical Center

Sendai, 983-8520

Japan

Iwate Medical University Hospital

Shiwa-gun, 028-3695

Japan

Tokushima University Hospital

Tokushima, 770-8503

Japan

Tokyo Medical University Hospital

Tokyo, 160-0023

Japan

iBiomed Research Unit

Aguascalientes, 20010

Mexico

Consultorio Dr. Miguel Cortes

Cuernavaca, 62448

Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, 44280

Mexico

Neurocentrum Bydgoszcz Sp Z O O

Bydgoszcz, 85 796

Poland

Neurologia Slaska Centrum Medyczne

Katowice, 40-689

Poland

Centrum Neurologii Klinicznej Krakowska Akademia Neurologii

Krakow, 31 505

Poland

Prywatny Gabinet Lekarski

Lublin, 20 093

Poland

Centrum Medyczne NeuroProtect

Warsaw, 01-684

Poland

Pusan National University Hospital

Busan, 49241

South Korea

Kyungpook National University Chilgok Hospital

Daegu, 41404

South Korea

Kyungpook National University Hospital

Daegu, 41944

South Korea

Severance Hospital Yonsei University Health System

Seoul, 120-752

South Korea

Hosp. Gral. Univ. de Alicante

Alicante, 03010

Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08025

Spain

Hosp Univ Vall D Hebron

Barcelona, 08035

Spain

Hosp Clinic de Barcelona

Barcelona, 8036

Spain

Hosp. Univ. de Basurto

Bilbao, 48013

Spain

Hosp. Virgen Macarena

Seville, 41009

Spain

Hosp. Virgen Del Rocio

Seville, 41013

Spain

Hosp. Univ. I Politecni La Fe

Valencia, 46026

Spain

Karlstad Central Hospital

Karlstad, 651 85

Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, 171 76

Sweden

China Medical University Hospital

Taichung, 40447

Taiwan

Shin Kong Wu Ho Su Memorial Hospital

Taipei, 111

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan