NCT04951622RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 199 (estimated)
- First submitted
- 30 Jun 2021
- Start date
- 15 Jul 2021
- Primary completion date
- 17 Nov 2023
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Myasthenia gravis
- NCT number
- NCT04951622
- EU CT number
- 2023-504152-97-00
- EudraCT number
- 2020-005732-29
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 199
- From 15 Jul 2021 to the primary completion date, 17 Nov 2023
- 102 sites in 17 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study
- For the SC Substudy (Cohort 1): Participants who have undergone a recent tapering of their concomitant MG medication in the OLE. Reminder that increasing the dose of existing MG therapy or starting new MG therapy anytime throughout study conduct is prohibited.
- 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)
Other illness
- 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 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (102)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Melbourne Neurology Group Coordinator of this site? Confirm its status | North Melbourne | Australia | Completed |
| Gold Coast University Hospital Coordinator of this site? Confirm its status | Southport | Australia | Recruiting |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Az St-Jan Brugge-Oostende A.V. Coordinator of this site? Confirm its status | Brugge | Belgium | Recruiting |
| AZ Sint-Lucas & Volkskliniek Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| McGill University Coordinator of this site? Confirm its status | Montreal | Canada | Completed |
| The Ottawa Hospital Research Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Completed |
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Bethune Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Completed |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Completed |
| The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Completed |
| Qianfoshan Hospital of Shandong Province Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Completed |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| MINKSneuro s.r.o. Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Vseobecna Fakultni Nemocnice V Praze Coordinator of this site? Confirm its status | Prague 2 | Czechia | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Completed |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Completed |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Completed |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Hopitaux Universitaires Pitie Salpetriere Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Neurological Institute Foundation Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Chiba University Hospital Coordinator of this site? Confirm its status | Chiba | Japan | Completed |
| General Hanamaki Hospital Coordinator of this site? Confirm its status | Hanamaki | Japan | Recruiting |
| Hiroshima University Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Recruiting |
| St. Marianna University Hospital Coordinator of this site? Confirm its status | Kawasaki-shi | Japan | Recruiting |
| Kagawa University Hospital Coordinator of this site? Confirm its status | Kita-gun | Japan | Completed |
| Kumamoto University Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Completed |
| National Hospital Organization Nagoya Medical Center Coordinator of this site? Confirm its status | Nagoya | Japan | Completed |
| Niigata City General Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Recruiting |
| Hyogo College of Medicine Hospital Coordinator of this site? Confirm its status | Nishinomiya-shi | Japan | Recruiting |
| Sapporo Medical University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Completed |
| Hokkaido Medical Center Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| National Hospital Organization Sendai Medical Center Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| Iwate Medical University Hospital Coordinator of this site? Confirm its status | Shiwa-gun | Japan | Recruiting |
| Teikyo University Hospital Coordinator of this site? Confirm its status | tabashi City | Japan | Recruiting |
| Tokushima University Hospital Coordinator of this site? Confirm its status | Tokushima | Japan | Completed |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Completed |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Completed |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| iBiomed Research Unit Coordinator of this site? Confirm its status | Aguascalientes | Mexico | Completed |
| Consultorio Dr. Miguel Cortes Coordinator of this site? Confirm its status | Cuernavaca | Mexico | Recruiting |
| Hospital Civil de Guadalajara Fray Antonio Alcalde Coordinator of this site? Confirm its status | Guadalajara | Mexico | Recruiting |
| Neurocentrum Bydgoszcz sp. z o.o Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Krakowska Akademia Neurologii Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Neurologia Śląska Centrum Medyczne Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Clinirem Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Centrum Medyczne NeuroProtect Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Completed |
| Shin Kong Wu Ho Su Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Augusta University Coordinator of this site? Confirm its status | Augusta | United States | Completed |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| FM Clinical Research, LLC South Florida Neurology Associates, P. A. Coordinator of this site? Confirm its status | Boca Raton | United States | Recruiting |
| St. Elizabeth Medical Center Coordinator of this site? Confirm its status | Boston | United States | Completed |
| Lahey Hospital & Medical Center Coordinator of this site? Confirm its status | Burlington | United States | Completed |
| University of Vermont Coordinator of this site? Confirm its status | Burlington | United States | Completed |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Completed |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Completed |
| Wesley Neurology Coordinator of this site? Confirm its status | Cordova | United States | Completed |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Completed |
| Duke University School of Medicine Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| University of Florida Health Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Completed |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Completed |
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Completed |
| Neuromuscular Research Center and Clinic Coordinator of this site? Confirm its status | Paradise Valley | United States | Recruiting |
| Care Access Research Coordinator of this site? Confirm its status | Pasadena | United States | Recruiting |
| Medsol Clinical Research Center Inc Coordinator of this site? Confirm its status | Port Charlotte | United States | Recruiting |
| HonorHealth Neurology Coordinator of this site? Confirm its status | Scottsdale | United States | Completed |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Completed |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
Related publications
- Efficacy of nipocalimab in patients with moderate-to-severe ocular symptoms of generalized myasthenia gravis in the phase 3 Vivacity-MG3 study.Expert Opin Biol Ther · 2026 · PMID 42675831
- Effect of nipocalimab on IgG responses to vaccinations and viral infections in patients with IgG autoantibody-mediated diseases: Post hoc analyses of three randomized, placebo-controlled trials.Hum Vaccin Immunother · 2026 · PMID 42084498
This page is information, not medical advice. Discuss any trial with your doctor.