A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
NCT ID: NCT04951622
Last Updated: 2025-11-13
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
219 participants
INTERVENTIONAL
2021-07-15
2026-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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 continue to receive nipocalimab q2w IV infusion till study end.
Nipocalimab
Nipocalimab will be administered as an IV infusion.
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.
Placebo
Matching placebo will be administered as an IV infusion.
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.
Nipocalimab SC-LIV
Nipocalimab will be administered subcutaneously.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
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
Napoli, , 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
Iwate Medical University Hospital
Morioka, , 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
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
NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'
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
Countries
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References
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Antozzi C, Fitzgibbon M. An evaluation of nipocalimab for the treatment of generalized myasthenia gravis. Expert Opin Biol Ther. 2025 Sep 30:1-12. doi: 10.1080/14712598.2025.2561935. Online ahead of print.
Raborn A, Savord A, Houts CR, Pease S, Scippa K, Ramchandren S. Psychometric analysis of the Neuro-QoL Fatigue in generalized Myasthenia Gravis (gMG) using data from a phase 3 trial. Qual Life Res. 2025 Sep;34(9):2577-2589. doi: 10.1007/s11136-025-03998-9. Epub 2025 Jun 14.
Antozzi C, Vu T, Ramchandren S, Nowak RJ, Farmakidis C, Bril V, De Bleecker J, Yang H, Minks E, Park JS, Grudniak M, Smilowski M, Sevilla T, Hoffmann S, Sivakumar K, Suzuki Y, Youssef E, Sanga P, Karcher K, Zhu Y, Sheehan JJ, Sun H; Vivacity-MG3 Study Group. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025 Feb;24(2):105-116. doi: 10.1016/S1474-4422(24)00498-8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MOM-M281-011
Identifier Type: OTHER
Identifier Source: secondary_id
2020-005732-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504152-97-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109046
Identifier Type: -
Identifier Source: org_study_id