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

RECRUITINGPHASE3

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

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)

NCT05271409•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants who are aged \>=12 years at the time of signing Informed Consent Form
•Confirmed diagnosis of MOGAD with a history of \>=1 MOGAD relapse in the 12 months prior to screening or \>=2 attacks in the 24 months prior to screening
•Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
•High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening
•Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening
•For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab

Exclusion Criteria

•Presence of aquaporin-4-antibodies immunoglobin G (AQP4-IgG) in the serum
•History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis
•Any concomitant disease other than MOGAD that may require treatment with ISTs or oral corticosteroids (OCS) or intravenous (IV) corticosteroids at doses \> 20 milligrams (mg) prednisone equivalent per day for \>21 days during the study
•Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
•Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
•Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
•Participants with positive screening tests for hepatitis B and C
•Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
•History of severe allergic reaction to a biologic agent

Locations (82)

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

Northwestern University

Chicago, Illinois, United States

Consultants in Neurology Ltd

Northbrook, Illinois, United States

Key Dates

Start Date

August 30, 2022

Primary Completion Date

November 20, 2025

Completion Date

December 31, 2028

Last Updated

March 13, 2026

Enrollment

152

ESTIMATED participants

Conditions

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

Interventions

Satralizumab

DRUG

Placebo

OTHER

Contacts

Reference Study ID Number: WN43194 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.)global-roche-genentech-trials@gene.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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