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

Purpose

The main objective of the 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

Condition

  • Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 - Best corrected 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 (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 OCS or intravenous (IV) corticosteroids at doses >20 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group A: Satralizumab 		In the double-blind 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.
  • Drug: Satralizumab
    Study drug 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.
Placebo Comparator
Group B: Placebo 		In the double-blind treatment period, participants will receive satralizumab matching placebo 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.
  • Other: Placebo
    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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35249

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: WN43194, https://forpatients.roche.com/
888-662-6728 (U.S.)
global-roche-genentech-trials@gene.com