A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

Phase 3

Recruiting

• Conditions: Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
• Interventions: Drug: Satralizumab; Other: Placebo

• Registration Number: NCT05271409
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-09
• Study Start: 2022-08-30
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-17
• Last Update Posted: 2025-10-20
• Primary Completion: 2026-07-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Satralizumab	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	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.

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 Adjudicated MOGAD Relapses	Up to approximately 44 months
Annualized Rate of Active Lesions on Magnetic Resonance Imaging (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

Trial Locations

Locations (82)

Wielospecjalistyczna Poradnia Lekarska Synapsis; 🇵🇱 Katowice, Poland

Instytut Pomnik Centrum Zdrowia Dziecka; 🇵🇱 Warsaw, Poland

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic- Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

University of California Irvine - Manchester Pavilion; 🇺🇸 Irvine, California, United States

University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center); 🇺🇸 Aurora, Colorado, United States

Medstar Georgetown University Hospital; 🇺🇸 Washington D.C., 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

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