Clareo Health | A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
With
Chugai Pharmaceutical
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
