A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease
- Conditions
- Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
- Interventions
- Other: Placebo
- Registration Number
- NCT05271409
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The main objective of the 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 152
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B: Placebo Placebo In the double-blind treatment period, participants will receive satralizumab matching placebo 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. Group A: Satralizumab Satralizumab In the double-blind 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.
- Primary Outcome Measures
Name Time Method Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC) Up to approximately 44 months
- Secondary Outcome Measures
Name Time Method Annualized rate of active lesions on MRI of the neuroaxis Up to approximately 44 months Proportion of participants receiving rescue therapy Up to approximately 44 months Annualized rate of inpatient hospitalizations Up to approximately 44 months Annualized rate of adjudicated MOGAD relapses Up to approximately 44 months
Trial Locations
- Locations (75)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic- Scottsdale
🇺🇸Scottsdale, Arizona, United States
University of California Irvine - Manchester Pavilion
🇺🇸Orange, California, United States
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
🇺🇸Aurora, Colorado, United States
Medstar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
University of Florida College of Medicine Gainesville
🇺🇸Gainesville, Florida, United States
Nemours Children's Clinic - of the Nemours Foundation
🇺🇸Jacksonville, Florida, United States
Meridian Clinical Research, LLC
🇺🇸Savannah, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Consultants in Neurology Ltd
🇺🇸Northbrook, Illinois, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
🇺🇸Owosso, Michigan, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
Washington University School of Medicine in St. Louis
🇺🇸Saint Louis, Missouri, United States
NYU Langone
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Premier Neurology
🇺🇸Greenville, South Carolina, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Brain and Mind Research Institute
🇦🇺Camperdown, New South Wales, Australia
John Hunter Hospital
🇦🇺New Lambton, New South Wales, Australia
Sydney Children's Hospital
🇦🇺Randwick, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
St Vincent's Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Perron Institute for Neurological and Translational Science
🇦🇺Nedlands, Western Australia, Australia
Instituto de Neurologia de Curitiba
🇧🇷Curitiba, Paraná, Brazil
Instituto do Cerebro do Rio Grande do Sul
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Centro de Pesquisas Clinicas
🇧🇷Sao Paulo, São Paulo, Brazil
Hospital Universitario Gaffree e Guinle
🇧🇷Rio de Janeiro, Brazil
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Vestische Kinder- und Jugendklinik Datteln
🇩🇪Datteln, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Neurology UKSH Campus Kiel
🇩🇪Kiel, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Klinikum Großhadern, LMU
🇩🇪Munich, Germany
Hadassah University Hospital Ein Kerem
🇮🇱Jerusalem, Israel
Unity Health Toronto - St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
MUCH - Montreal Neurological Institute & Hospital
🇨🇦Montreal, Quebec, Canada
Hopital Pierre Wertheimer
🇫🇷Bron, France
CH de Bicêtre
🇫🇷Le Kremlin Bicêtre, France
CHU de Toulouse - Hôpital Purpan
🇫🇷Toulouse, France
NeuroCure Clinical Research Center (NCRC)
🇩🇪Berlin, Germany
St. Josef-Hospital, Klinik für Neurologie
🇩🇪Bochum, Germany
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Ospedale Pediatrico Bambino Gesù
🇮🇹Roma, Lazio, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milano, Lombardia, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Lombardia, Italy
Fondazione Istituto Neurologico Mondino IRCCS
🇮🇹Pavia, Lombardia, Italy
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga
🇮🇹Orbassano, Piemonte, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico
🇮🇹Catania, Sicilia, Italy
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Veneto, Italy
Chiba University Hospital
🇯🇵Chiba, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Southern Tohoku Medical Clinic
🇯🇵Fukushima, Japan
Kobe University Hospital
🇯🇵Hyogo, Japan
Kitasato University Hospital
🇯🇵Kanagawa, Japan
Tohoku University Hospital
🇯🇵Miyagi, Japan
Tohoku Medical and Pharmaceutical University Hospital
🇯🇵Miyagi, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
Saitama Medical Center
🇯🇵Saitama, Japan
The Jikei University Hospital
🇯🇵Tokyo, Japan
Juntendo University Hospital
🇯🇵Tokyo, Japan
Tokyo Medical University Hospital
🇯🇵Tokyo, Japan
Keio University Hospital
🇯🇵Tokyo, Japan
Tokyo Women's Medical University Hospital
🇯🇵Tokyo, Japan
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of