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

Primary Purpose

Generalized Myasthenia Gravis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Satralizumab
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Myasthenia Gravis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • HonorHealth Neurology
  • Keck School of Medicine of USCRecruiting
  • University of California Irvine - Manchester PavilionRecruiting
  • SC3 Research Group, IncRecruiting
  • Childrens National Health CenterRecruiting
  • Medical Faculty Associates Inc.
  • University of Florida Jacksonville Physicians Inc. (UFJPI)
  • University of Chicago HospitalRecruiting
  • Prairie Education and Research
  • University of Iowa Hospitals & Clinics; Department of NeurologyRecruiting
  • Massachusetts General Hospital
  • Washington University School of Medicine; Department of Neurology
  • University at Buffalo / SUNY; UBMD Neurology
  • South Shore Neurologic Associates P.C.
  • NeuroScience Research CenterRecruiting
  • The Ohio State University Wexner Medical Center; Department of NeurologyRecruiting
  • Hospital Italiano; Neurology
  • Hospital Ramos Mejía
  • Hospital Britanico
  • Fundación Scherbovsky; General Department
  • INECO Neurociencias Orono
  • Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
  • Concord Repatriation General HospitalRecruiting
  • Princess Alexandra Hospital
  • Box Hill Hospital; Department of Neurology
  • Instituto de Neurologia de Curitiba
  • Hospital Sao Lucas - PUCRS
  • Hospital das Clinicas - UNICAMP
  • Faculdade de Medicina do ABC - FMABCRecruiting
  • Hospital Sao Paulo
  • MUCH - Montreal Neurological Institute & HospitalRecruiting
  • Beijing Tiantan Hospital,Capital Medical University
  • Beijing Tongren Hospital
  • The First Hospital of Jilin UniversityRecruiting
  • Hunan Children's HospitalRecruiting
  • Xiangya Hospital Central South UniversityRecruiting
  • West China Hospital - Sichuan University
  • The Affiliated Hospital of Guizhou Medical UniversityRecruiting
  • Sir Run Run Shaw HospitalRecruiting
  • The First Affiliated Hospital Of Shandong First Medical UniversityRecruiting
  • Huashan Hospital, Fudan University
  • Children's Hospital of Fudan UniversityRecruiting
  • Tianjin Medical University General Hospital
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Tangdu Hospital
  • Aarhus Universitetshospital; Neurologisk Klinik
  • Rigshospitalet; Klinik for Nerve- og MuskelsygdommeRecruiting
  • APHP Raymond Poincare
  • Hopital Timone Adultes; Neurologie Mal Neuro Musculaires
  • CHU de Nantes - Hotel Dieu
  • CHU Nice - Hôpital Pasteur 2; SYST NERVEUX PERIPHERIQUE MUSCLE
  • CHU BordeauxRecruiting
  • St. Josef-Hospital, Klinik für NeurologieRecruiting
  • Universitätsklinikum Essen (AöR); Klinik für NeurologieRecruiting
  • Univeristätsklinikum Leipzig; Klinik und Poliklinik für Neurologie
  • Universitätsklinikum Münster; Klinik und Poliklinik für NeurologieRecruiting
  • Azienda Ospedaliera A. Cardarelli; Dipartimento medico polispecialistico
  • A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)Recruiting
  • Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie NeuromuscolariRecruiting
  • Fondazione Istituto Neurologico Mondino IRCCS; SC Neuroncologia e neuroinfiammazioneRecruiting
  • A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit
  • Ospedale Cà Foncello; S.C Neurologia
  • Juntendo University Hospital; NeurologyRecruiting
  • Chiba University Hospital; Neurology
  • General Hanamaki Hospital; Neurology
  • Hiroshima University HospitalRecruiting
  • Sapporo Medical University Hospital; NeurologyRecruiting
  • NHO Hokkaido Medical CenterRecruiting
  • Kagawa University Hospital; NeurologyRecruiting
  • St. Marianna University Hospital
  • Saitama Medical Center; NeurologyRecruiting
  • Nagasaki Kawatana Medical Center; NeurologyRecruiting
  • International University of Health and Welfare Narita Hospital; Neurology
  • Kindai University Hospital; NeurologyRecruiting
  • Osaka Toneyama Medical Center; NeurologyRecruiting
  • Dokkyo Medical University Saitama Medical Center; NeurologyRecruiting
  • Tokyo Women's Medical University Hospital; NeurologyRecruiting
  • Seirei Hamamatsu General HospitalRecruiting
  • Osaka University Hospital; Neurology
  • Tokyo Medical And Dental University, Medical Hospital; NeurologyRecruiting
  • Tokyo Medical University Hospital
  • Kyungpook National University Chilgok HospitalRecruiting
  • Pusan National University Yangsan HospitalRecruiting
  • Korea University Anam Hospital
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical CenterRecruiting
  • Amsterdam UMC Location AMC
  • LUMCRecruiting
  • Klinika Neurologii Doros?ych, Uniwersyteckie Centrum Kliniczne
  • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
  • Zespol Poradni Specjalistycznych - Poradnia Neurologiczna; Szpital Uniwersytecki w Krakowie
  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
  • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
  • Krasnoyarsk State Medical AcademyRecruiting
  • National Center of Social Significant Disease
  • Leningrad Regional Clinical Hospital
  • Novosibirsk State Regional Clinical HospitalRecruiting
  • Hospital Universitari de Bellvitge; Servicio de NeurologiaRecruiting
  • Hospital de Donostia Unidad Demencias; Consultas de Neurología
  • Hospital Universitario Infanta Sofia; Servicio de Neurologia
  • Clinica Universitaria de Navarra; Servicio de Neurología
  • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
  • Clinica Universitaria Navarra; Servicio NeurologiaRecruiting
  • Hospital Universitario la Fe; Servicio de NeurologiaRecruiting
  • Taipei Veterans General Hospital-Neurology
  • Chang Gung Medical Foundation Linkou BranchRecruiting
  • Hacettepe University Medical Faculty; Neurology
  • Ege University Medical FacultyRecruiting
  • Kocaeli University Hospital; Department of NeurologyRecruiting
  • Ondokuz Mayis Univ. Med. Fac.; Neurology
  • Karadeniz Tecnical Uni. Med. Fac.; Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Satralizumab

Placebo

Arm Description

Participants will receive Satralizumab at Weeks 0, 2, 4, and Q4W thereafter. Adolescent patients who first enter the study in the OLE period will receive satralizumab SC loading doses at Week 0, 2, and 4 in the OLE, followed by maintenance doses Q4W thereafter and will remain on stable background therapy until Week 24 of the OLE.

Participants will receive placebo at Weeks 0, 2, 4, and Q4W thereafter

Outcomes

Primary Outcome Measures

Mean change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in AChR-antibody seropositive population

Secondary Outcome Measures

Mean change from baseline in Quantitative Myasthenia Gravis (QMG) score
Mean change from baseline in Myasthenia Gravis Quality of Life 15 Scale (MG-QOL 15r) score
Mean change from baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Subscale score
Mean change from baseline in total Myasthenia Gravis Composite (MGC) score
Proportion of MG-ADL responders
Proportion of QMG responder
Proportion of MGC responders
Proportion of participants who have achieved minimal disease manifestation (total MG-ADL score of 0 or 1)

Full Information

First Posted
July 7, 2021
Last Updated
October 3, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04963270
Brief Title
A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Myasthenia Gravis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
185 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Satralizumab
Arm Type
Experimental
Arm Description
Participants will receive Satralizumab at Weeks 0, 2, 4, and Q4W thereafter. Adolescent patients who first enter the study in the OLE period will receive satralizumab SC loading doses at Week 0, 2, and 4 in the OLE, followed by maintenance doses Q4W thereafter and will remain on stable background therapy until Week 24 of the OLE.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo at Weeks 0, 2, 4, and Q4W thereafter
Intervention Type
Drug
Intervention Name(s)
Satralizumab
Intervention Description
Satralizumab will be administered as a subcutaneous injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Satralizumab placebo will be administered as a subcutaneous injection
Primary Outcome Measure Information:
Title
Mean change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in AChR-antibody seropositive population
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Mean change from baseline in Quantitative Myasthenia Gravis (QMG) score
Time Frame
Week 24
Title
Mean change from baseline in Myasthenia Gravis Quality of Life 15 Scale (MG-QOL 15r) score
Time Frame
Week 24
Title
Mean change from baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Subscale score
Time Frame
Week 24
Title
Mean change from baseline in total Myasthenia Gravis Composite (MGC) score
Time Frame
Week 24
Title
Proportion of MG-ADL responders
Time Frame
Week 24
Title
Proportion of QMG responder
Time Frame
Week 24
Title
Proportion of MGC responders
Time Frame
Week 24
Title
Proportion of participants who have achieved minimal disease manifestation (total MG-ADL score of 0 or 1)
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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) 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 Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: GE42063 https://forpatients.roche.com/
Phone
888-662-6728 (U.S.)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
HonorHealth Neurology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Withdrawn
Facility Name
Keck School of Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Irvine - Manchester Pavilion
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
SC3 Research Group, Inc
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens National Health Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Faculty Associates Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Florida Jacksonville Physicians Inc. (UFJPI)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Prairie Education and Research
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Iowa Hospitals & Clinics; Department of Neurology
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2621
Country
United States
Individual Site Status
Withdrawn
Facility Name
Washington University School of Medicine; Department of Neurology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University at Buffalo / SUNY; UBMD Neurology
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Withdrawn
Facility Name
South Shore Neurologic Associates P.C.
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Individual Site Status
Withdrawn
Facility Name
NeuroScience Research Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University Wexner Medical Center; Department of Neurology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital Italiano; Neurology
City
Caba
ZIP/Postal Code
C1199ABA
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Hospital Ramos Mejía
City
Caba
ZIP/Postal Code
C1221ADC
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Hospital Britanico
City
Ciudad Autonoma Bs As
ZIP/Postal Code
C1280AEB
Country
Argentina
Individual Site Status
Completed
Facility Name
Fundación Scherbovsky; General Department
City
Mendoza
ZIP/Postal Code
M5500AYB
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
INECO Neurociencias Orono
City
Rosario
ZIP/Postal Code
S2000DTC
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
City
San Miguel
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Box Hill Hospital; Department of Neurology
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Instituto de Neurologia de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
81210-310
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital das Clinicas - UNICAMP
City
Campinas
State/Province
SP
ZIP/Postal Code
13083-887
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Faculdade de Medicina do ABC - FMABC
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04037-002
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
MUCH - Montreal Neurological Institute & Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Beijing Tiantan Hospital,Capital Medical University
City
Beijing City
ZIP/Postal Code
100050
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Tongren Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun City
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Children's Hospital
City
Changsha City
ZIP/Postal Code
410007
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangya Hospital Central South University
City
Changsha City
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital - Sichuan University
City
Chengdu City
ZIP/Postal Code
610047
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang City
ZIP/Postal Code
550000
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou City
ZIP/Postal Code
310018
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital Of Shandong First Medical University
City
Jinan City
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Name
Huashan Hospital, Fudan University
City
Shanghai City
ZIP/Postal Code
200040
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Children's Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou City
ZIP/Postal Code
325035
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430030
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tangdu Hospital
City
Xi'an City
ZIP/Postal Code
710038
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Aarhus Universitetshospital; Neurologisk Klinik
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Rigshospitalet; Klinik for Nerve- og Muskelsygdomme
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
APHP Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Timone Adultes; Neurologie Mal Neuro Musculaires
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de Nantes - Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Withdrawn
Facility Name
CHU Nice - Hôpital Pasteur 2; SYST NERVEUX PERIPHERIQUE MUSCLE
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
St. Josef-Hospital, Klinik für Neurologie
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Essen (AöR); Klinik für Neurologie
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Univeristätsklinikum Leipzig; Klinik und Poliklinik für Neurologie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera A. Cardarelli; Dipartimento medico polispecialistico
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Istituto Neurologico Mondino IRCCS; SC Neuroncologia e neuroinfiammazione
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Cà Foncello; S.C Neurologia
City
Treviso
State/Province
Veneto
ZIP/Postal Code
31100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Juntendo University Hospital; Neurology
City
Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chiba University Hospital; Neurology
City
Chiba-shi, Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
General Hanamaki Hospital; Neurology
City
Hanamaki, Iwate
ZIP/Postal Code
025-0082
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo Medical University Hospital; Neurology
City
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Individual Site Status
Recruiting
Facility Name
NHO Hokkaido Medical Center
City
Hokkaido
ZIP/Postal Code
063-0005
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kagawa University Hospital; Neurology
City
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Individual Site Status
Recruiting
Facility Name
St. Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Saitama Medical Center; Neurology
City
Kawagoe-shi, Saitama
ZIP/Postal Code
350-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagasaki Kawatana Medical Center; Neurology
City
Nagasaki
ZIP/Postal Code
859-3615
Country
Japan
Individual Site Status
Recruiting
Facility Name
International University of Health and Welfare Narita Hospital; Neurology
City
Narita, Chiba
ZIP/Postal Code
286-0124
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kindai University Hospital; Neurology
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Toneyama Medical Center; Neurology
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dokkyo Medical University Saitama Medical Center; Neurology
City
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Women's Medical University Hospital; Neurology
City
Shinjuku-ku
ZIP/Postal Code
162-8666
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seirei Hamamatsu General Hospital
City
Shizuoka
ZIP/Postal Code
430-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka University Hospital; Neurology
City
Suita
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokyo Medical And Dental University, Medical Hospital; Neurology
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Yangsan Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Amsterdam UMC Location AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
LUMC
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Klinika Neurologii Doros?ych, Uniwersyteckie Centrum Kliniczne
City
Gda?sk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Zespol Poradni Specjalistycznych - Poradnia Neurologiczna; Szpital Uniwersytecki w Krakowie
City
Kraków
ZIP/Postal Code
31-503
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
City
Lublin
ZIP/Postal Code
20-410
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
City
Krasnoyarsk
State/Province
Krasnojarsk
ZIP/Postal Code
660037
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Krasnoyarsk State Medical Academy
City
Krasnoyarsk
State/Province
Krasnojarsk
ZIP/Postal Code
660049
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
National Center of Social Significant Disease
City
Sankt-peterburg
State/Province
Leningrad
ZIP/Postal Code
197110
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Leningrad Regional Clinical Hospital
City
St Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Novosibirsk State Regional Clinical Hospital
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Hospital Universitari de Bellvitge; Servicio de Neurologia
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de Donostia Unidad Demencias; Consultas de Neurología
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20080
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario Infanta Sofia; Servicio de Neurologia
City
San Sebastian de los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Clinica Universitaria de Navarra; Servicio de Neurología
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Clinica Universitaria Navarra; Servicio Neurologia
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario la Fe; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital-Neurology
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Chang Gung Medical Foundation Linkou Branch
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Hacettepe University Medical Faculty; Neurology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli University Hospital; Department of Neurology
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ondokuz Mayis Univ. Med. Fac.; Neurology
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Karadeniz Tecnical Uni. Med. Fac.; Neurology
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Learn more about this trial

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

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