A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Last updated: April 2, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Sarcopenia

Treatment

Nipocalimab

Placebo

Clinical Study ID

NCT04951622
CR109046
2020-005732-29
MOM-M281-011
2023-504152-97-00
  • Ages > 18
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting theclinical criteria for generalized myasthenia gravis (gMG) as defined by theMyasthenia 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 orequal to (>=) 6 at screening and baseline

  • Has sufficient venous access to allow drug administration by infusion and bloodsampling 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 urinepregnancy test at Day 1 prior to administration of study intervention

  • A male participant must agree not to donate sperm for the purpose of reproductionduring the study and for a minimum 90 days after receiving the last administrationof study intervention

Exclusion

Exclusion Criteria:

  • Has any confirmed or suspected clinical immunodeficiency syndrome not related totreatment of his/her gMG, or has a family history of congenital or hereditaryimmunodeficiency 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 'burntout' MG)

  • Has had a thymectomy within 12 months prior to screening, or thymectomy is plannedduring the study

  • Has known allergies, hypersensitivity, or intolerance to nipocalimab or itsexcipients

  • Has experienced myocardial infarction, unstable ischemic heart disease, or strokewithin 12 weeks of screening

Study Design

Total Participants: 196
Treatment Group(s): 2
Primary Treatment: Nipocalimab
Phase: 3
Study Start date:
July 15, 2021
Estimated Completion Date:
April 17, 2026

Connect with a study center

  • Townsville Hospital

    Douglas, Queensland
    Australia

    Site Not Available

  • Melbourne Neurology Group

    North Melbourne, 3051
    Australia

    Completed

  • Gold Coast University Hospital

    Southport, 4215
    Australia

    Active - Recruiting

  • ULB Hôpital Erasme

    Anderlecht, 1070
    Belgium

    Active - Recruiting

  • AZ Sint Jan Brugge Oostende AV

    Brugge, 8000
    Belgium

    Active - Recruiting

  • AZ Sint-Jan Brugge-Oostende AV

    Brugge, 8000
    Belgium

    Active - Recruiting

  • Cliniques Universitaires Saint Luc

    Brussels, 1200
    Belgium

    Active - Recruiting

  • AZ Sint-Lucas

    Gent, 9000
    Belgium

    Active - Recruiting

  • University Hospitals Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario K1Y 4E9
    Canada

    Active - Recruiting

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • McGill University

    Montreal, Quebec H3A 2B4
    Canada

    Completed

  • Beijing Hospital

    Beijing, 100730
    China

    Active - Recruiting

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100050
    China

    Active - Recruiting

  • Xuanwu Hospital ,Capital Medical University

    Beijing, 100053
    China

    Completed

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053
    China

    Active - Recruiting

  • The First Bethune Hospital of Jilin University

    Changchun, 130021
    China

    Active - Recruiting

  • Central South University Xiangya Hospital The First Affiliated Hospital of Hunan Medical College

    Changsha, 410008
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, 410008
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, 610041
    China

    Completed

  • Fujian Medical University Union Hospital

    Fuzhou, 350001
    China

    Completed

  • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

    Guangzhou, 510405
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310020
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 310020
    China

    Active - Recruiting

  • Qianfoshan hospital of Shandong Province

    Jinan, 250014
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, 250014
    China

    Completed

  • Huashan Hospital Fudan University

    Shanghai, 200040
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Active - Recruiting

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

    Xi'An, 710038
    China

    Active - Recruiting

  • Medicity S.A.S

    Bucaramanga, 681012
    Colombia

    Site Not Available

  • Fundacion Cardiovascular de Colombia

    Floridablanca, 680004
    Colombia

    Site Not Available

  • Fakultni nemocnice Brno

    Brno, 625 00
    Czechia

    Completed

  • Neurologie a rehabilitace Skopalíkova

    Brno, 615 00
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Ostrava

    Ostrava, 70852
    Czechia

    Site Not Available

  • Vseobecna Fakultní Nemocnice

    Praha, 12808
    Czechia

    Active - Recruiting

  • Aalborg University Hospital

    Aalborg, 9000
    Denmark

    Active - Recruiting

  • Aarhus Universitetshospital

    Aarhus, DK-8200
    Denmark

    Site Not Available

  • Rigshospitalet

    København Ø, 2100
    Denmark

    Completed

  • Hopital Pierre Wertheimer

    Bron, 69500
    France

    Active - Recruiting

  • CHU Grenoble

    Grenoble, 38043
    France

    Completed

  • Hopital de la Pitie Salpetriere

    Paris, 75013
    France

    Active - Recruiting

  • Hopital PASTEUR

    Provence-Alpes-Côte d'Azur, 06000
    France

    Active - Recruiting

  • NeuroCure Clinical Research Center

    Berlin, 10117
    Germany

    Active - Recruiting

  • Kreiskrankenhaus Gummersbach

    Gummersbach, 51643
    Germany

    Site Not Available

  • Universitatsmedizin Gottingen

    Göttingen, 37075
    Germany

    Active - Recruiting

  • Universitätsmedizin Göttingen

    Göttingen, 37075
    Germany

    Active - Recruiting

  • Universitätsklinikum Jena

    Jena, 07747
    Germany

    Site Not Available

  • Universitaetsklinikum Leipzig

    Leipzig, 04103
    Germany

    Completed

  • Universitatsklinikum Leipzig

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Universitatsklinikum Schleswig Holstein Campus Lubeck

    Lübeck, 23538
    Germany

    Completed

  • Universitätsklinikum Schleswig Holstein Campus Lübeck

    Lübeck, 23538
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar der TU Munchen

    München, 81675
    Germany

    Site Not Available

  • Universitatsklinikum Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

  • DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie

    Wiesbaden, 65191
    Germany

    Completed

  • U.O.P.I. di Psichiatria

    Catania, 95100
    Italy

    Completed

  • Fondazione Istituto G. Giglio

    Cefalu, 90015
    Italy

    Active - Recruiting

  • Istituto Neurologico Carlo Besta

    Milano, 20133
    Italy

    Active - Recruiting

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

    Napoli, 80138
    Italy

    Active - Recruiting

  • IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione

    Pavia, 27100
    Italy

    Active - Recruiting

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

    Roma, 00189
    Italy

    Completed

  • Policlinico Universitario Agostino Gemelli

    Roma, 168
    Italy

    Active - Recruiting

  • Chiba University Hospital

    Chiba, 260 8677
    Japan

    Completed

  • General Hanamaki Hospital

    Hanamaki, 025-0082
    Japan

    Active - Recruiting

  • Hiroshima University Hospital

    Hiroshima, 734-8551
    Japan

    Site Not Available

  • Hiroshima University Hospital

    Hiroshima shi, 734 8551
    Japan

    Active - Recruiting

  • Hiroshima University Hospital

    Hiroshima-shi, 734-8551
    Japan

    Site Not Available

  • Teikyo University Hospital

    Itabashi Ku, 173 8606
    Japan

    Active - Recruiting

  • Teikyo University Hospital

    Itabashi-Ku, 173-8606
    Japan

    Site Not Available

  • St Marianna University Hospital

    Kawasaki Shi, 216 8511
    Japan

    Active - Recruiting

  • St.Marianna University Hospital

    Kawasaki-Shi, 216-8511
    Japan

    Site Not Available

  • Kagawa University Hospital

    Kita Gun, 761 0793
    Japan

    Completed

  • Kagawa University Hospital

    Kita-Gun, 761-0793
    Japan

    Site Not Available

  • Kumamoto University Hospital

    Kumamoto, 860-8556
    Japan

    Completed

  • Iwate Medical University Hospital

    Morioka-shi, 020-8505
    Japan

    Active - Recruiting

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001
    Japan

    Site Not Available

  • National Hospital Organization Nagoya Medical Center

    Nagoya-shi, 460-0001
    Japan

    Active - Recruiting

  • Niigata City General Hospital

    Niigata, 950-1197
    Japan

    Active - Recruiting

  • Hyogo College of Medicine Hospital

    Nishinomiya-Shi, 663-8501
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osaka-Sayama, 589-8511
    Japan

    Site Not Available

  • Kindai University Hospital

    Osaka-Sayama-shi, 589-8511
    Japan

    Site Not Available

  • Hokkaido Medical Center

    Sapporo, 063 0005
    Japan

    Active - Recruiting

  • Sapporo Medical University Hospital

    Sapporo, 0608556
    Japan

    Completed

  • National Hospital Organization Sendai Medical Center

    Sendai, 983-8520
    Japan

    Site Not Available

  • National Hospital Organization Sendai Medical Center

    Sendai-City, 983-8520
    Japan

    Active - Recruiting

  • Tokushima University Hospital

    Tokushima, 770-8503
    Japan

    Active - Recruiting

  • Teikyo University Hospital

    Tokyo, 173-8606
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Tokyo, 160-0023
    Japan

    Completed

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Completed

  • Severance Hospital, Yonsei University Health System

    Seodaemun, 120-752
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, 120-752
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan-si, 50612
    Korea, Republic of

    Site Not Available

  • iBiomed Research Unit

    Aguascalientes, 20010
    Mexico

    Completed

  • Consultorio Dr. Miguel Cortes

    Cuernavaca, 62448
    Mexico

    Active - Recruiting

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280
    Mexico

    Active - Recruiting

  • Neurocentrum Bydgoszcz Sp Z O O

    Bydgoszcz, 85 796
    Poland

    Active - Recruiting

  • NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'

    Katowice, 40-123
    Poland

    Active - Recruiting

  • Centrum Neurologii Klinicznej Krakowska Akademia Neurologii

    Krakow, 31 505
    Poland

    Active - Recruiting

  • Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii

    Krakow, 31-505
    Poland

    Active - Recruiting

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324
    Poland

    Site Not Available

  • Prywatny Gabinet Lekarski

    Lublin, 20 093
    Poland

    Active - Recruiting

  • Clinical Research Center sp. z o.o MEDIC-R s.k.

    Poznań, 60-848
    Poland

    Site Not Available

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-684
    Poland

    Active - Recruiting

  • Regional State Budgetary Healthcare Organization 'Regional Clinical Hospital'

    Barnaul, 656024
    Russian Federation

    Site Not Available

  • Research Medical Center Your Health

    Kazan, 420097
    Russian Federation

    Site Not Available

  • Kemerovo Region Clinical Hospital

    Kemerovo, 650066
    Russian Federation

    Site Not Available

  • Chaika Health - Clinic Chaika

    Moscow, 123112
    Russian Federation

    Site Not Available

  • Regional Clinical Hospital n.a.Semashko

    Nizhniy Novgorod, 603126
    Russian Federation

    Site Not Available

  • Novosibirsk Region Clinical Hospital

    Novosibirsk, 630087
    Russian Federation

    Site Not Available

  • Institute of Human Brain Ras

    St. Petersburg, 197376
    Russian Federation

    Site Not Available

  • Hosp. Gral. Univ. de Alicante

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hosp Clinic de Barcelona

    Barcelona, 8036
    Spain

    Active - Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hosp. Clinic I Provincial de Barcelona

    Barcelona, 8036
    Spain

    Active - Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 8036
    Spain

    Active - Recruiting

  • Hosp. Univ. Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Hosp. de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Hosp. Univ. de Basurto

    Bilbao, 48013
    Spain

    Active - Recruiting

  • Hosp. Gral. Univ. Gregorio Marañon

    Madrid, 28007
    Spain

    Site Not Available

  • Hosp. Virgen Del Rocio

    Sevilla, 41013
    Spain

    Completed

  • Hosp. Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Karlstad Central Hospital

    Karlstad, 651 85
    Sweden

    Completed

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76
    Sweden

    Active - Recruiting

  • Chang Gung Memorial Hospital Kaohsiung Branch

    Kaohsiung, 833
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Completed

  • Shin Kong Wu Ho Su Memorial Hospital

    Taipei, 111
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Bezmialem University Medical Faculty

    Fatih, 34093
    Turkey

    Site Not Available

  • Istanbul Universitesi Istanbul Tip Fakültesi

    Istanbul, 34098
    Turkey

    Site Not Available

  • Selçuk Üniversitesi Tıp Fakültesi Hastanesi

    Konya, 42130
    Turkey

    Site Not Available

  • Mersin Universitesi Tip Fakultesi

    Mersin, 33079
    Turkey

    Site Not Available

  • Karadeniz Teknik University Medical Faculty

    Trabzon, 61080
    Turkey

    Site Not Available

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • St George's Hospital

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2 JF
    United Kingdom

    Site Not Available

  • IMC-Diagnostic and Medical Clinic

    Mobile, Alabama 36604
    United States

    Site Not Available

  • Neuromuscular Research Center and Clinic

    Paradise Valley, Arizona 85028
    United States

    Active - Recruiting

  • HonorHealth Neurology

    Scottsdale, Arizona 85251
    United States

    Completed

  • University of Southern California

    Los Angeles, California 90033
    United States

    Completed

  • Stanford University

    Palo Alto, California 94304
    United States

    Completed

  • Care Access Research

    Pasadena, California 91101
    United States

    Active - Recruiting

  • University of Colorado - Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

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

    Boca Raton, Florida 33487
    United States

    Active - Recruiting

  • University of Florida Health Jacksonville

    Jacksonville, Florida 32209
    United States

    Completed

  • Medsol Clinical Research Center Inc

    Port Charlotte, Florida 33952
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Augusta University

    Augusta, Georgia 30912-3125
    United States

    Completed

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • St. Elizabeth Medical Center

    Boston, Massachusetts 02135
    United States

    Completed

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts 01805
    United States

    Completed

  • Washington University School Of Medicine

    Saint Louis, Missouri 63110
    United States

    Completed

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Las Vegas Medical Research

    Las Vegas, Nevada 89145
    United States

    Site Not Available

  • Atrium Health

    Charlotte, North Carolina 28078
    United States

    Site Not Available

  • Duke University School of Medicine

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Completed

  • Cleveland Clinic

    Cleveland, Ohio 44145
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Wesley Neurology

    Cordova, Tennessee 38018
    United States

    Completed

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Completed

  • University of Vermont

    Burlington, Vermont 05401
    United States

    Completed

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