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)

Brief description of study

This Phase III, randomized, double-blind (DB), placebo-controlled, multicenter study is designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo as monotherapy or in addition (add-on) to baseline/background ISTs for MOGAD relapse prevention. The study will include a screening period of up to 28 days, an event-driven DB treatment period, and an approximately 2-year open-label extension (OLE) period.

Clinical Study Identifier: s21-01090

ClinicalTrials.gov Identifier: NCT05271409

Principal Investigator: Ilya Kister.

Other Investigators: Mirza Omari, Tyler Ellis Smith, Vito Pasquale Arena.

Contact the research team to learn more about this study.

Your Email

Not a valid e-mail address

Please Provide Email Address

First Name

First name is mandatory

Last Name

Your Phone

Please provide phone number

Invalid phone number

Valid phone number

Comments

Send Confirmation of This To Me

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.

Clinical Research Studies