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
Scroll for more (65 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States