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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
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

Full criteria on ClinicalTrials.gov

Sites (102)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Melbourne Neurology Group
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North MelbourneAustraliaCompleted
Gold Coast University Hospital
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SouthportAustraliaRecruiting
Hopital Erasme
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AnderlechtBelgiumRecruiting
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumRecruiting
AZ Sint-Lucas & Volkskliniek
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GentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
McGill University
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MontrealCanadaCompleted
The Ottawa Hospital Research Institute
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OttawaCanadaRecruiting
Toronto General Hospital
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TorontoCanadaRecruiting
Beijing Hospital
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BeijingChinaRecruiting
Xuanwu Hospital, Capital Medical University
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BeijingChinaCompleted
Beijing Tiantan Hospital,Capital Medical University
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BeijingChinaRecruiting
The First Bethune Hospital of Jilin University
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ChangchunChinaRecruiting
Xiangya Hospital Central South University
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ChangshaChinaRecruiting
West China Hospital of Sichuan University
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ChengduChinaCompleted
Fujian Medical University Union Hospital
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FuzhouChinaCompleted
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
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GuangzhouChinaRecruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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HangzhouChinaCompleted
Qianfoshan Hospital of Shandong Province
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JinanChinaRecruiting
Qilu Hospital of Shandong University
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JinanChinaCompleted
Huashan Hospital, Fudan University
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ShanghaiChinaRecruiting
Tianjin Medical University General Hospital
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TianjinChinaRecruiting
The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
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Xi'anChinaRecruiting
MINKSneuro s.r.o.
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BrnoCzechiaRecruiting
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Universitaetsmedizin Goettingen
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GoettingenGermanyCompleted
Universitaetsklinikum Ulm AoR
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UlmGermanyCompleted
Aalborg University Hospital
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AalborgDenmarkCompleted
Rigshospitalet
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Copenhagen OeDenmarkCompleted
Hospital General Universitario Dr. Balmis
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AlicanteSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitario Basurto
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BilbaoSpainRecruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Hospices Civils de Lyon
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BronFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Hopitaux Universitaires Pitie Salpetriere
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Paris Cedex 13FranceRecruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyRecruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyRecruiting
Neurological Institute Foundation Casimiro Mondino
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PaviaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Chiba University Hospital
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ChibaJapanCompleted
General Hanamaki Hospital
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HanamakiJapanRecruiting
Hiroshima University Hospital
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HiroshimaJapanRecruiting
St. Marianna University Hospital
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Kawasaki-shiJapanRecruiting
Kagawa University Hospital
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Kita-gunJapanCompleted
Kumamoto University Hospital
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KumamotoJapanCompleted
National Hospital Organization Nagoya Medical Center
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NagoyaJapanCompleted
Niigata City General Hospital
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NiigataJapanRecruiting
Hyogo College of Medicine Hospital
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Nishinomiya-shiJapanRecruiting
Sapporo Medical University Hospital
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SapporoJapanCompleted
Hokkaido Medical Center
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SapporoJapanRecruiting
National Hospital Organization Sendai Medical Center
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SendaiJapanRecruiting
Iwate Medical University Hospital
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Shiwa-gunJapanRecruiting
Teikyo University Hospital
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tabashi CityJapanRecruiting
Tokushima University Hospital
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TokushimaJapanCompleted
Tokyo Medical University Hospital
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TokyoJapanCompleted
Pusan National University Hospital
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BusanSouth KoreaRecruiting
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaRecruiting
Kyungpook National University Hospital
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DaeguSouth KoreaCompleted
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
iBiomed Research Unit
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AguascalientesMexicoCompleted
Consultorio Dr. Miguel Cortes
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CuernavacaMexicoRecruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde
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GuadalajaraMexicoRecruiting
Neurocentrum Bydgoszcz sp. z o.o
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BydgoszczPolandRecruiting
Krakowska Akademia Neurologii Sp. z o.o.
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CracowPolandRecruiting
Neurologia Śląska Centrum Medyczne
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KatowicePolandRecruiting
Clinirem Sp. z o.o.
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LublinPolandRecruiting
Centrum Medyczne NeuroProtect
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WarsawPolandRecruiting
Karolinska University Hospital
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SolnaSwedenRecruiting
China Medical University Hospital
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TaichungTaiwanCompleted
Shin Kong Wu Ho Su Memorial Hospital
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TaipeiTaiwanRecruiting
Taipei Veterans General Hospital
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TaipeiTaiwanRecruiting
Augusta University
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AugustaUnited StatesCompleted
University of Colorado Anschutz Medical Campus
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AuroraUnited StatesRecruiting
FM Clinical Research, LLC South Florida Neurology Associates, P. A.
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Boca RatonUnited StatesRecruiting
St. Elizabeth Medical Center
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BostonUnited StatesCompleted
Lahey Hospital & Medical Center
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BurlingtonUnited StatesCompleted
University of Vermont
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BurlingtonUnited StatesCompleted
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
University of Cincinnati
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CincinnatiUnited StatesCompleted
Cleveland Clinic
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ClevelandUnited StatesRecruiting
The Ohio State University
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ColumbusUnited StatesCompleted
Wesley Neurology
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CordovaUnited StatesCompleted
UT Southwestern Medical Center
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DallasUnited StatesCompleted
Duke University School of Medicine
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DurhamUnited StatesRecruiting
University of Florida Health Jacksonville
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JacksonvilleUnited StatesCompleted
University of Kansas Medical Center
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Kansas CityUnited StatesRecruiting
University of Southern California
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Los AngelesUnited StatesCompleted
Yale New Haven Hospital
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New HavenUnited StatesRecruiting
Stanford University
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Palo AltoUnited StatesCompleted
Neuromuscular Research Center and Clinic
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Paradise ValleyUnited StatesRecruiting
Care Access Research
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PasadenaUnited StatesRecruiting
Medsol Clinical Research Center Inc
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Port CharlotteUnited StatesRecruiting
HonorHealth Neurology
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ScottsdaleUnited StatesCompleted
Washington University School of Medicine
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St LouisUnited StatesCompleted
University of South Florida
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TampaUnited StatesRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.