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Evaluating satralizumab for treating MOGAD

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)

PHASE3 · Hoffmann-La Roche · NCT05271409

This study is testing if a new treatment called satralizumab can help people with MOGAD have fewer relapses compared to a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment152 (estimated)
Ages12 Years and up
SexAll
SponsorHoffmann-La Roche (industry)
Drugs / interventionssatralizumab, prednisone
Locations82 sites (Birmingham, Alabama and 81 other locations)
Trial IDNCT05271409 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab in patients diagnosed with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). Participants will be randomly assigned to receive either satralizumab or a placebo, and the primary outcome will focus on the time until the first relapse of MOGAD during the double-blind treatment period. The study will include patients aged 12 and older with a history of MOGAD relapses and specific eligibility criteria related to their health status. The trial is designed to provide insights into the potential benefits of satralizumab in managing this condition.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 and older with a confirmed diagnosis of MOGAD and a history of recent relapses.

Not a fit: Patients with aquaporin-4-antibodies or other specific neurological conditions may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of relapses in patients with MOGAD.

How similar studies have performed: Previous studies have shown promise in using similar monoclonal antibody therapies for autoimmune conditions, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 81 other locations

+32 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.