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NCT04963270TerminatedPhase 3

A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

Source: ClinicalTrials.gov · Last updated 28 Feb 2025

Reason given: Sponsor decided to halt development of satralizumab in generalized myasthenia gravis and discontinued further dosing with the study drug (while the OLE period was ongoing) upon reviewing the primary results (DB period).

Brief summary (registry, in English)

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).

Status (registry)
Terminated
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
188 (actual)
First submitted
7 Jul 2021
Start date
19 Oct 2021
Primary completion date
29 Jan 2024
Lead sponsor
Hoffmann-La Roche
NCT number
NCT04963270

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of thymectomy within 12 months prior to screening
  • Ocular MG (MGFA Class I) and myasthenic crisis (MGFA Class V) within the last 3 months prior to screening
  • Evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
  • Receipt of live or live attenuated vaccine within 6 weeks prior to baseline

Other illness

  • Known disease other than gMG that would interfere with the course and conduct of the study
  • Positive screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV)

Other

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose

Who the study is looking for

  • Signed Informed Consent Form
  • For adolescent patients: Informed Consent Form for study participation signed by the parents or a legal guardian, and patient assent obtained, as per local requirements
  • Ability to comply with the study protocol procedures
  • Confirmed diagnosis of gMG (anti-AChR, anti-MuSK or anti-LRP4 present at screening)
  • A total MG-ADL score of ≥ 5 points at screening with more than 50% of this score attributed to non-ocular items
  • MGFA severity Class II-IV
  • Ongoing gMG treatment at a stable dose
  • For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab.

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (76)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital ItalianoCABAArgentinaUnknown status
Hospital Ramos MejíaCABAArgentinaUnknown status
Hospital BritanicoCiudad Autonoma Bs AsArgentinaUnknown status
Fundacion ScherbovskyMendozaArgentinaUnknown status
INECO Neurociencias OroñoRosarioArgentinaUnknown status
Concord Repatriation General HospitalConcordAustraliaUnknown status
Hospital das Clinicas - UNICAMPCampinasBrazilUnknown status
Hospital Sao Lucas - PUCRSPorto AlegreBrazilUnknown status
Faculdade de Medicina do ABC - FMABCSanto AndréBrazilUnknown status
Hospital Sao PauloSão PauloBrazilUnknown status
MUCH - Montreal Neurological Institute & HospitalMontrealCanadaUnknown status
Beijing Tiantan Hospital,Capital Medical UniversityBeijingChinaUnknown status
Beijing Tongren HospitalBeijingChinaUnknown status
The First Hospital of Jilin UniversityChangchunChinaUnknown status
West China Hospital，Sichuan UniversityChengduChinaUnknown status
The Affiliated Hospital of Guizhou Medical UniversityGuiyangChinaUnknown status
Sir Run Run Shaw HospitalHangzhouChinaUnknown status
The First Affiliated Hospital of Shandong First Medical UniversityJinanChinaUnknown status
Huashan Hospital, Fudan UniversityShanghaiChinaUnknown status
Children's Hospital Of Fudan UniversityShanghaiChinaUnknown status
Tianjin Medical University General HospitalTianjinChinaUnknown status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhanChinaUnknown status
Tangdu HospitalXi'anChinaUnknown status
St. Josef-Hospital, Klinik für NeurologieBochumGermanyUnknown status
Universitätsklinikum Essen AöREssenGermanyUnknown status
Universitätsklinikum MünsterMünsterGermanyUnknown status
Aarhus UniversitetshospitalAarhus NDenmarkUnknown status
RigshospitaletKøbenhavn ØDenmarkUnknown status
Hospital de la Santa Creu i Sant PauBarcelonaSpainUnknown status
Hospital Universitari de BellvitgeL'Hospitalet de LlobregatSpainUnknown status
Clinica Universitaria de NavarraPamplonaSpainUnknown status
Hospital Universitario la FeValenciaSpainUnknown status
CHU BordeauxBordeauxFranceUnknown status
APHP Raymond PoincareGarchesFranceUnknown status
Hopital Timone AdultesMarseilleFranceUnknown status
CHU de Nantes - Hôtel DieuNantesFranceUnknown status
CHU Nice - Hôpital Pasteur 2NiceFranceUnknown status
Fond. Istituto Neurologico C.BestaMilanItalyUnknown status
Azienda Ospedaliera A. CardarelliNaplesItalyUnknown status
A.R.N.A.S. Civico Di Cristina BenfratelliPalermoItalyUnknown status
Ospedale Ca' FoncelloTrevisoItalyUnknown status
Juntendo University HospitalBunkyō CityJapanUnknown status
Chiba University HospitalChiba-shi, ChibaJapanUnknown status
General Hanamaki HospitalHanamaki, IwateJapanUnknown status
NHO Hokkaido Medical CenterHokkaidoJapanUnknown status
Sapporo Medical University HospitalHokkaidoJapanUnknown status
St Marianna University HospitalKanagawaJapanUnknown status
International University of Health and Welfare Narita HospitalNarita, ChibaJapanUnknown status
Kindai University HospitalOsakaJapanUnknown status
Seirei Hamamatsu General HospitalShizuokaJapanUnknown status
Osaka University HospitalSuitaJapanUnknown status
Tokyo Medical University HospitalTokyoJapanUnknown status
Tokyo Medical And Dental University, Medical HospitalTokyoJapanUnknown status
Kyungpook National University Chilgok HospitalDaeguSouth KoreaUnknown status
Pusan National University Yangsan HospitalGyeongsangnam-doSouth KoreaUnknown status
Samsung Medical CenterSeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health SystemSeoulSouth KoreaUnknown status
Korea University Anam HospitalSeoulSouth KoreaUnknown status
Klinika Neurologii Doros?ych, Uniwersyteckie Centrum KliniczneGda?skPolandUnknown status
Zespol Poradni Specjalistycznych - Poradnia NeurologicznaKrakowPolandUnknown status
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii KKrakowPolandUnknown status
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.LublinPolandUnknown status
Krasnoyarsk State Medical AcademyKrasnoyarskRussiaUnknown status
Novosibirsk State Regional Clinical HospitalNovosibirskRussiaUnknown status
Hacettepe University Medical FacultyAnkaraTürkiyeUnknown status
Ege University Medical FacultyIzmirTürkiyeUnknown status
Kocaeli University HospitalKocaeliTürkiyeUnknown status
Ondokuz Mayis Univ. Med. Fac.SamsunTürkiyeUnknown status
Taipei Veterans General Hospital-NeurologyTaipeiTaiwanUnknown status
Chang Gung Medical Foundation Linkou BranchTaoyuan CityTaiwanUnknown status
University of Chicago HospitalChicagoUnited StatesUnknown status
Keck School of Medicine of USCLos AngelesUnited StatesUnknown status
Prairie Education and ResearchO'FallonUnited StatesUnknown status
University of California Irvine - Manchester PavilionOrangeUnited StatesUnknown status
SC3 Research Group Inc.PasadenaUnited StatesUnknown status
Medical Faculty Associates, Inc.Washington D.C.United StatesUnknown status

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