Status:
RECRUITING
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Chugai Pharmaceutical
Conditions:
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 doubl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT05271409
Start Date
August 30 2022
End Date
December 31 2028
Last Update
December 22 2025
Active Locations (82)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States, 85259
3
University of California Irvine - Manchester Pavilion
Irvine, California, United States, 92697
4
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
Aurora, Colorado, United States, 80045