A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

Phase 1

Recruiting

• Conditions: Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD); MedDRA version: 20.0Level: PTClassification code: 10075688Term: Autoimmune demyelinating disease Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-507196-22-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-07
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

1. Participants who are aged >=12 years at the time of signing Informed Consent Form and 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, 2. Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening, 3. High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening, 4. Participants receiving either no ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening or receiving ongoing treatment with azathioprine (AZA), mycophenolate mofetil (MMF), oral corticosteroids (OCS) or a combination of OCS and AZA or MMF prior to and at the time of screening, 5. No contraindications to rescue treatments and no contraindications to MRI, 6. 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

1. Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum, 2. History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis, 3. Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or intravenous (IV) corticosteroids at doses >20 mg prednisone equivalent per day for >21 days during the study, 4. Intravenous immunoglobulins (IVIg) or subcutaneous immunoglobulins ( ScIg) within 4 weeks prior to screening, 5. Plasma exchange (PLEX) within 4 weeks prior to screening, 6. Systemic corticosteroids, AZA or MMF within 4 weeks prior to screening (if not continued as concomitant IST in the study)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. 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;Secondary Objective: 1. To evaluate the efficacy of satralizumab compared with placebo based on rate of adjudicated MOGAD relapses, presence of active lesions on magnetic resonance imaging (MRI) of the neuroaxis, rescue therapy use, inpatient hospitalizations, and proportion of relapse-free participants at 6-month intervals, 2. To evaluate the safety of satralizumab compared with placebo;Primary end point(s): 1. Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC)