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

Launched by HOFFMANN-LA ROCHE · Feb 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called satralizumab to see how well it works in treating a condition known as Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). The main goal is to find out if satralizumab can help prevent relapses, which are episodes where symptoms come back or worsen, compared to a placebo (a treatment that looks like the real drug but has no active ingredients). They are currently looking for participants aged 12 and older who have had at least one relapse in the past year or two relapses in the past two years. Eligible participants should also have a certain level of physical ability and vision.

If you join this trial, you will be part of a double-blind study, meaning neither you nor your doctor will know if you are receiving the actual medication or the placebo. Throughout the study, you will be monitored for safety and how well the medication works. It's important to note that there are specific requirements for participation, such as not having certain other medical conditions or infections, and women of childbearing age must agree to use contraception. Overall, this trial aims to provide new insights into treating MOGAD and could potentially help improve the lives of those affected by this condition.

Gender

ALL

Eligibility 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