Examining the Effects of Nipocalimab on Muscle Strength in Adults with Myasthenia Gravis
NCT04951622 · RecruitingThis trial looks at how well nipocalimab works for adults with generalized myasthenia gravis (gMG). It compares nipocalimab to a placebo, which is a treatment with no active medicine. The goal is to see if nipocalimab can improve muscle strength and daily activities in people with this condition. There is also a part of the study that looks at how the medicine is given, either by injection under the skin or through an IV.
Locations and contact
This trial is running at 112 locations in 17 countries. 68 of them are currently recruiting.
United States24 locations · 11 recruiting
- Care Access ResearchPasadena, CaliforniaRecruiting
- Cleveland ClinicCleveland, OhioRecruiting
- Duke University School of MedicineDurham, North CarolinaRecruiting
- FM Clinical Research, LLC South Florida Neurology Associates, P. A.Boca Raton, FloridaRecruiting
- Medical University of South CarolinaCharleston, South CarolinaRecruiting
- Medsol Clinical Research Center IncPort Charlotte, FloridaRecruiting
- Neuromuscular Research Center and ClinicParadise Valley, ArizonaRecruiting
- University of Colorado Anschutz Medical CampusAurora, ColoradoRecruiting
- University of Kansas Medical CenterKansas City, KansasRecruiting
- University of South FloridaTampa, FloridaRecruiting
- Yale New Haven HospitalNew Haven, ConnecticutRecruiting
- Augusta UniversityAugusta, GeorgiaCompleted
- HonorHealth NeurologyScottsdale, ArizonaCompleted
- Lahey Hospital & Medical CenterBurlington, MassachusettsCompleted
- St. Elizabeth Medical CenterBoston, MassachusettsCompleted
- Stanford UniversityPalo Alto, CaliforniaCompleted
- The Ohio State UniversityColumbus, OhioCompleted
- University of CincinnatiCincinnati, OhioCompleted
- University of Florida Health JacksonvilleJacksonville, FloridaCompleted
- University of Southern CaliforniaLos Angeles, CaliforniaCompleted
- University of VermontBurlington, VermontCompleted
- UT Southwestern Medical CenterDallas, TexasCompleted
- Washington University School Of MedicineSt Louis, MissouriCompleted
- Wesley NeurologyCordova, TennesseeCompleted
Japan16 locations · 9 recruiting
- General Hanamaki HospitalHanamakiRecruiting
- Hiroshima University HospitalHiroshimaRecruiting
- Hokkaido Medical CenterSapporoRecruiting
- Hyogo College of Medicine HospitalNishinomiya-ShiRecruiting
- Iwate Medical University HospitalMoriokaRecruiting
- National Hospital Organization Sendai Medical CenterSendaiRecruiting
- Niigata City General HospitalNiigataRecruiting
- St Marianna University HospitalKawasaki ShiRecruiting
- Teikyo University HospitalItabashi KuRecruiting
- Chiba University HospitalChibaCompleted
- Kagawa University HospitalKita GunCompleted
- Kumamoto University HospitalKumamotoCompleted
- National Hospital Organization Nagoya Medical CenterNagoyaCompleted
- Sapporo Medical University HospitalSapporoCompleted
- Tokushima University HospitalTokushimaCompleted
- Tokyo Medical University HospitalTokyoCompleted
China14 locations · 9 recruiting
- Beijing HospitalBeijingRecruiting
- Beijing Tiantan Hospital, Capital Medical UniversityBeijingRecruiting
- Huashan Hospital Fudan UniversityShanghaiRecruiting
- Qianfoshan hospital of Shandong ProvinceJinanRecruiting
- The First Affiliated Hospital of Guangzhou University of Traditional Chinese MedicineGuangzhouRecruiting
- The First Bethune Hospital of Jilin UniversityChangchunRecruiting
- The Second Affiliated Hospital of Air Force Medical University - Tangdu HospitalXi'anRecruiting
- Tianjin Medical University General HospitalTianjinRecruiting
- Xiangya Hospital Central South UniversityChangshaRecruiting
- Fujian Medical University Union HospitalFuzhouCompleted
- Qilu Hospital of Shandong UniversityJinanCompleted
- Sir Run Run Shaw Hospital Zhejiang University School of MedicineHangzhouCompleted
- West China Hospital of Sichuan UniversityChengduCompleted
- Xuanwu Hospital ,Capital Medical UniversityBeijingCompleted
Spain8 locations · 7 recruiting
- Hosp Clinic de BarcelonaBarcelonaRecruiting
- Hosp Univ Vall D HebronBarcelonaRecruiting
- Hosp. de La Santa Creu I Sant PauBarcelonaRecruiting
- Hosp. Gral. Univ. de AlicanteAlicanteRecruiting
- Hosp. Univ. de BasurtoBilbaoRecruiting
- Hosp. Univ. I Politecni La FeValenciaRecruiting
- Hosp. Virgen MacarenaSevilleRecruiting
- Hosp. Virgen Del RocioSevilleCompleted
Italy7 locations · 5 recruiting
- Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi VanvitelliNaplesRecruiting
- Fondazione Istituto G. GiglioCefalùRecruiting
- IRCCS C. Mondino, Istituto Neurologico Nazionale, FondazionePaviaRecruiting
- Istituto Neurologico Carlo BestaMilanRecruiting
- Policlinico Universitario Agostino GemelliRomaRecruiting
- Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La SapienzaRomaCompleted
- U.O.P.I. di PsichiatriaCataniaCompleted
Belgium5 locations · 5 recruiting
- AZ Sint Jan Brugge Oostende AVBrugesRecruiting
- AZ Sint-LucasGhentRecruiting
- Cliniques Universitaires Saint LucBrusselsRecruiting
- ULB Hôpital ErasmeAnderlechtRecruiting
- University Hospitals LeuvenLeuvenRecruiting
Poland5 locations · 5 recruiting
- Centrum Medyczne NeuroProtectWarsawRecruiting
- Centrum Neurologii Klinicznej Krakowska Akademia NeurologiiKrakowRecruiting
- Neurocentrum Bydgoszcz Sp Z O OBydgoszczRecruiting
- NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'KatowiceRecruiting
- Prywatny Gabinet LekarskiLublinRecruiting
France5 locations · 3 recruiting
- Hopital de la Pitie SalpetriereParisRecruiting
- Hopital PASTEURProvence-Alpes-Côte d'AzurRecruiting
- Hopital Pierre WertheimerBronRecruiting
- CHU GrenobleGrenobleCompleted
- Hopital PASTEURProvence-Alpes-Côte d'AzurCompleted
South Korea4 locations · 3 recruiting
- Kyungpook National University Chilgok HospitalDaeguRecruiting
- Pusan National University HospitalBusanRecruiting
- Severance Hospital Yonsei University Health SystemSeoulRecruiting
- Kyungpook National University HospitalDaeguCompleted
Canada3 locations · 2 recruiting
- The Ottawa Hospital Research InstituteOttawa, OntarioRecruiting
- Toronto General HospitalToronto, OntarioRecruiting
- McGill UniversityMontreal, QuebecCompleted
Czechia3 locations · 2 recruiting
- Neurologie a rehabilitace SkopalíkovaBrnoRecruiting
- Vseobecna Fakultní NemocnicePragueRecruiting
- Fakultni nemocnice BrnoBrnoCompleted
Mexico3 locations · 2 recruiting
- Consultorio Dr. Miguel CortesCuernavacaRecruiting
- Hospital Civil de Guadalajara Fray Antonio AlcaldeGuadalajaraRecruiting
- iBiomed Research UnitAguascalientesCompleted
Taiwan3 locations · 2 recruiting
- Shin Kong Wu Ho Su Memorial HospitalTaipeiRecruiting
- Taipei Veterans General HospitalTaipeiRecruiting
- China Medical University HospitalTaichungCompleted
Germany6 locations · 1 recruiting
- NeuroCure Clinical Research CenterBerlinRecruiting
- DKD HELIOS Klinik Wiesbaden, Fachbereich NeurologieWiesbadenCompleted
- Universitaetsklinikum LeipzigLeipzigCompleted
- Universitatsklinikum Schleswig Holstein Campus LubeckLübeckCompleted
- Universitatsklinikum UlmUlmCompleted
- Universitatsmedizin GottingenGöttingenCompleted
Australia2 locations · 1 recruiting
- Gold Coast University HospitalSouthportRecruiting
- Melbourne Neurology GroupNorth MelbourneCompleted
Sweden2 locations · 1 recruiting
- Karolinska Universitetssjukhuset SolnaStockholmRecruiting
- Karlstad Central HospitalKarlstadCompleted
Denmark2 locations
- Aalborg University HospitalAalborgCompleted
- RigshospitaletKøbenhavn ØCompleted
Who can join
Adults aged 18 and older can join this study. Both men and women are welcome. Participants must have a diagnosis of generalized myasthenia gravis and meet specific health criteria. However, some people, like those with certain heart conditions or severe issues with their myasthenia gravis, cannot participate. The trial team will confirm who is eligible.
What happens during the trial
Participants will be randomly placed into one of three groups. One group will receive nipocalimab through an IV every two weeks for up to 24 weeks. Another group will receive a matching placebo through an IV for the same time. The third group will receive nipocalimab as an injection under the skin once a week for 8 weeks. After this, participants can continue with the nipocalimab treatment.
The trial team
This trial is sponsored by Janssen Research & Development, LLC. The study director is also from Janssen Research & Development, LLC.
Important dates
The trial started on July 15, 2021, and is currently recruiting participants. It is expected to finish by March 30, 2029. The main part of the study is expected to be completed by November 17, 2023.
Additional information
The trial's ID number is NCT04951622. It is a Phase 3 study, which means it is looking at how well the treatment works and its safety. This study is regulated by the FDA. It aims to include around 199 participants.
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