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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
152
Study drug will be administered by subcutaneous (SC) injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit.
Placebo will be administered by SC injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGMayo Clinic- Scottsdale
Scottsdale, Arizona, United States
WITHDRAWNUniversity of California Irvine - Manchester Pavilion
Irvine, California, United States
RECRUITINGUniversity of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
Aurora, Colorado, United States
Time From Randomization to the First Occurrence of a MOGAD Relapse in the DB Treatment Period, as Determined by an Adjudication Committee (CEC)
Time frame: Up to approximately 44 months
Annualized Rate of Adjudicated MOGAD Relapses
Time frame: Up to approximately 44 months
Annualized Rate of Active Lesions on Magnetic Resonance Imaging (MRI) of the Neuroaxis
Time frame: Up to approximately 44 months
Proportion of Participants Receiving Rescue Therapy
Time frame: Up to approximately 44 months
Annualized Rate of Inpatient Hospitalizations
Time frame: Up to approximately 44 months
Reference Study ID Number: WN43194 https://forpatients.roche.com/
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Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
RECRUITINGUniversity of Florida College of Medicine Gainesville
Gainesville, Florida, United States
RECRUITINGNemours Children's Clinic - of the Nemours Foundation
Jacksonville, Florida, United States
RECRUITINGMeridian Clinical Research, LLC
Savannah, Georgia, United States
WITHDRAWNNorthwestern University
Chicago, Illinois, United States
WITHDRAWNConsultants in Neurology Ltd
Northbrook, Illinois, United States
WITHDRAWN...and 72 more locations