Satralizumab
DrugStudy 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.
NCT Number: NCT05271409
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.
This study is active but is not currently recruiting participants.
Notify Me12 year and older
All sexes
Interventional
Phase 3
Brain and Mind Research Institute, Camperdown, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to approximately 44 months
Time frame: Up to approximately 44 months
Time frame: Up to approximately 44 months
Time frame: Up to approximately 44 months
Time frame: Up to approximately 44 months
Hoffmann-La Roche
Industry
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)
Acronym: Meteoroid
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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