A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab as Monotherapy or in Addition to Baseline Therapy in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)
Status: Recruiting
Location: See all (82) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• Participants who are aged \>=12 years at the time of signing Informed Consent Form
• Confirmed diagnosis of MOGAD with a history of \>=1 MOGAD relapse in the 12 months prior to screening or \>=2 attacks in the 24 months prior to screening
• Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
• High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening
• Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening
• For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Mayo Clinic- Scottsdale
WITHDRAWN
Scottsdale
California
University of California Irvine - Manchester Pavilion
RECRUITING
Irvine
Colorado
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
RECRUITING
Aurora
Washington, D.c.
Medstar Georgetown University Hospital
RECRUITING
Washington D.c.
Florida
University of Florida College of Medicine Gainesville
RECRUITING
Gainesville
Nemours Children's Clinic - of the Nemours Foundation
WITHDRAWN
Jacksonville
Georgia
Meridian Clinical Research, LLC
WITHDRAWN
Savannah
Illinois
Northwestern University
WITHDRAWN
Chicago
Consultants in Neurology Ltd
WITHDRAWN
Northbrook
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins
RECRUITING
Baltimore
Michigan
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
RECRUITING
Owosso
Minnesota
Mayo Clinic - Rochester
RECRUITING
Rochester
Missouri
Washington University School of Medicine in St. Louis
RECRUITING
St Louis
North Carolina
Duke University Medical Center
WITHDRAWN
Durham
New York
NYU Langone
RECRUITING
New York
Ohio
University of Cincinnati
ACTIVE_NOT_RECRUITING
Cincinnati
Cleveland Clinic Foundation
RECRUITING
Cleveland
OhioHealth Research Institute
WITHDRAWN
Columbus
South Carolina
Premier Neurology
COMPLETED
Greenville
Texas
Baylor College of Medicine
WITHDRAWN
Houston
Wisconsin
Medical College of Wisconsin
COMPLETED
Milwaukee
Other Locations
Australia
Box Hill Hospital
WITHDRAWN
Box Hill
Brain and Mind Research Institute
RECRUITING
Camperdown
Monash Medical Centre
RECRUITING
Clayton
St Vincent's Hospital Melbourne
WITHDRAWN
Fitzroy
Perron Institute for Neurological and Translational Science
RECRUITING
Nedlands
John Hunter Hospital
RECRUITING
New Lambton
Royal Melbourne Hospital
WITHDRAWN
Parkville
Sydney Children's Hospital
RECRUITING
Randwick
Royal North Shore Hospital
WITHDRAWN
St Leonards
Brazil
Instituto de Neurologia de Curitiba
RECRUITING
Curitiba
Instituto do Cerebro do Rio Grande do Sul
RECRUITING
Porto Alegre
Hospital Universitario Gaffree e Guinle
RECRUITING
Rio De Janeiro
Centro de Pesquisas Clinicas
RECRUITING
São Paulo
Canada
London Health Sciences Centre Uni Campus
RECRUITING
London
MUCH - Montreal Neurological Institute & Hospital
RECRUITING
Montreal
Children's Hospital of Eastern Ontario
RECRUITING
Ottawa
The Hospital for Sick Children
RECRUITING
Toronto
Unity Health Toronto - St. Michael's Hospital
WITHDRAWN
Toronto
France
Hopital Pierre Wertheimer
RECRUITING
Bron
CH de Bicêtre
RECRUITING
Le Kremlin-bicêtre
CHU de Toulouse - Hôpital Purpan
WITHDRAWN
Toulouse
Germany
NeuroCure Clinical Research Center (NCRC)
ACTIVE_NOT_RECRUITING
Berlin
St. Josef-Hospital, Klinik für Neurologie
ACTIVE_NOT_RECRUITING
Bochum
Vestische Kinder- und Jugendklinik Datteln
RECRUITING
Datteln
Universitätsklinikum Düsseldorf
ACTIVE_NOT_RECRUITING
Düsseldorf
Neurology UKSH Campus Kiel
ACTIVE_NOT_RECRUITING
Kiel
Universitätsklinikum Mannheim
ACTIVE_NOT_RECRUITING
Mannheim
Klinikum Großhadern, LMU
ACTIVE_NOT_RECRUITING
Munich
Israel
Hadassah University Hospital Ein Kerem
RECRUITING
Jerusalem
Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico
RECRUITING
Catania
Fondazione IRCCS Istituto Neurologico Carlo Besta
WITHDRAWN
Milan
IRCCS Ospedale San Raffaele
WITHDRAWN
Milan
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga
RECRUITING
Orbassano
Fondazione Istituto Neurologico Mondino IRCCS
RECRUITING
Pavia
Ospedale Pediatrico Bambino Gesù
WITHDRAWN
Rome
Azienda Ospedaliera Universitaria Integrata Verona
RECRUITING
Verona
Japan
Chiba University Hospital
RECRUITING
Chiba
Kyushu University Hospital
RECRUITING
Fukuoka
Southern Tohoku Medical Clinic
RECRUITING
Fukushima
Kobe University Hospital
RECRUITING
Hyōgo
Kitasato University Hospital
RECRUITING
Kanagawa
Tohoku Medical and Pharmaceutical University Hospital
RECRUITING
Miyagi
Tohoku University Hospital
RECRUITING
Miyagi
The University of Osaka Hospital
RECRUITING
Osaka
Saitama Medical Center
RECRUITING
Saitama
Juntendo University Hospital
RECRUITING
Tokyo
Keio University Hospital
RECRUITING
Tokyo
The Jikei University Hospital
RECRUITING
Tokyo
Tokyo Medical University Hospital
RECRUITING
Tokyo
Tokyo Women's Medical University Hospital
WITHDRAWN
Tokyo
Poland
Wielospecjalistyczna Poradnia Lekarska Synapsis
ACTIVE_NOT_RECRUITING
Katowice
Szpital Uniwersytecki w Krakowie
WITHDRAWN
Krakow
Centrum Medyczne MEDYK
WITHDRAWN
Rzeszów
Instytut Pomnik Centrum Zdrowia Dziecka
RECRUITING
Warsaw
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
RECRUITING
Warsaw
SPSK nr 1
ACTIVE_NOT_RECRUITING
Zabrze
Republic of Korea
National Cancer Center
ACTIVE_NOT_RECRUITING
Goyang-si
Samsung Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Seoul National University Hospital
ACTIVE_NOT_RECRUITING
Seoul
Contact Information
Primary
Reference Study ID Number: WN43194 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)
Time Frame
Start Date: 2022-08-30
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 152
Treatments
Experimental: Satralizumab
In the DB treatment period, participants will receive satralizumab at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open-label treatment with satralizumab. Additional adolescent participants will be directly enrolled in the OLE period to receive satralizumab.
Placebo_comparator: Placebo
In the DB treatment period, participants will receive satralizumab matching placebo at Weeks 0, 2, 4 (loading doses) and maintenance doses Q4W thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical