RecruitingPhase 3NCT04951622

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

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


Sponsor

Janssen Research & Development, LLC

Enrollment

199 participants

Start Date

Jul 15, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Nipocalimab, a drug called Nipocalimab SC-LIV, and others for people with myasthenia gravis. The study is currently recruiting participants at 112 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNipocalimab

Nipocalimab will be administered as an IV infusion.

DRUGPlacebo

Matching placebo will be administered as an IV infusion.

DRUGNipocalimab SC-LIV

Nipocalimab will be administered subcutaneously.


Locations(112)

Neuromuscular Research Center and Clinic

Paradise Valley, Arizona, United States

HonorHealth Neurology

Scottsdale, Arizona, United States

University of Southern California

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

Care Access Research

Pasadena, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

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

Boca Raton, Florida, United States

University of Florida Health Jacksonville

Jacksonville, Florida, United States

Medsol Clinical Research Center Inc

Port Charlotte, Florida, United States

University of South Florida

Tampa, Florida, United States

Augusta University

Augusta, Georgia, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

St. Elizabeth Medical Center

Boston, Massachusetts, United States

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Duke University School of Medicine

Durham, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Wesley Neurology

Cordova, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

University of Vermont

Burlington, Vermont, United States

Melbourne Neurology Group

North Melbourne, Australia

Gold Coast University Hospital

Southport, Australia

ULB Hôpital Erasme

Anderlecht, Belgium

AZ Sint Jan Brugge Oostende AV

Bruges, Belgium

Cliniques Universitaires Saint Luc

Brussels, Belgium

AZ Sint-Lucas

Ghent, Belgium

University Hospitals Leuven

Leuven, Belgium

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

McGill University

Montreal, Quebec, Canada

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Xuanwu Hospital ,Capital Medical University

Beijing, China

Beijing Hospital

Beijing, China

The First Bethune Hospital of Jilin University

Changchun, China

Xiangya Hospital Central South University

Changsha, China

West China Hospital of Sichuan University

Chengdu, China

Fujian Medical University Union Hospital

Fuzhou, China

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, China

Qianfoshan hospital of Shandong Province

Jinan, China

Qilu Hospital of Shandong University

Jinan, China

Huashan Hospital Fudan University

Shanghai, China

Tianjin Medical University General Hospital

Tianjin, China

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

Xi'an, China

Neurologie a rehabilitace Skopalíkova

Brno, Czechia

Fakultni nemocnice Brno

Brno, Czechia

Vseobecna Fakultní Nemocnice

Prague, Czechia

Aalborg University Hospital

Aalborg, Denmark

Rigshospitalet

København Ø, Denmark

Hopital Pierre Wertheimer

Bron, France

CHU Grenoble

Grenoble, France

Hopital de la Pitie Salpetriere

Paris, France

Hopital Pasteur 1

Provence-Alpes-Côte d'Azur, France

Hopital PASTEUR

Provence-Alpes-Côte d'Azur, France

NeuroCure Clinical Research Center

Berlin, Germany

Universitatsmedizin Gottingen

Göttingen, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Universitatsklinikum Schleswig Holstein Campus Lubeck

Lübeck, Germany

Universitatsklinikum Ulm

Ulm, Germany

DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie

Wiesbaden, Germany

U.O.P.I. di Psichiatria

Catania, Italy

Fondazione Istituto G. Giglio

Cefalù, Italy

Istituto Neurologico Carlo Besta

Milan, Italy

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

Naples, Italy

IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione

Pavia, Italy

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

Roma, Italy

Policlinico Universitario Agostino Gemelli

Roma, Italy

Chiba University Hospital

Chiba, Japan

General Hanamaki Hospital

Hanamaki, Japan

Hiroshima University Hospital

Hiroshima, Japan

Teikyo University Hospital

Itabashi Ku, Japan

St Marianna University Hospital

Kawasaki Shi, Japan

Kagawa University Hospital

Kita Gun, Japan

Kumamoto University Hospital

Kumamoto, Japan

National Hospital Organization Nagoya Medical Center

Nagoya, Japan

Niigata City General Hospital

Niigata, Japan

Hyogo College of Medicine Hospital

Nishinomiya-Shi, Japan

Sapporo Medical University Hospital

Sapporo, Japan

Hokkaido Medical Center

Sapporo, Japan

National Hospital Organization Sendai Medical Center

Sendai, Japan

Iwate Medical University Hospital

Shiwa-gun, Japan

Tokushima University Hospital

Tokushima, Japan

Tokyo Medical University Hospital

Tokyo, Japan

iBiomed Research Unit

Aguascalientes, Mexico

Consultorio Dr. Miguel Cortes

Cuernavaca, Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Mexico

Neurocentrum Bydgoszcz Sp Z O O

Bydgoszcz, Poland

Neurologia Slaska Centrum Medyczne

Katowice, Poland

Centrum Neurologii Klinicznej Krakowska Akademia Neurologii

Krakow, Poland

Prywatny Gabinet Lekarski

Lublin, Poland

Centrum Medyczne NeuroProtect

Warsaw, Poland

Pusan National University Hospital

Busan, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Hosp. Gral. Univ. de Alicante

Alicante, Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp. Univ. de Basurto

Bilbao, Spain

Hosp. Virgen Macarena

Seville, Spain

Hosp. Virgen Del Rocio

Seville, Spain

Hosp. Univ. I Politecni La Fe

Valencia, Spain

Karlstad Central Hospital

Karlstad, Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden

China Medical University Hospital

Taichung, Taiwan

Shin Kong Wu Ho Su Memorial Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

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NCT04951622


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