Satralizumab Treatment for MOGAD—Positive Results Announced from Phase 3 Trial
Results of the phase 3 METEOROID clinical trial (NCT05271409) showed that satralizumab (Roche, Basel, Switzerland; Genentech, South San Francisco, CA) treatment prevented and/or delayed time to myelin oligodendrocyte glycoprotein antibody–associated disease (MOGAD) relapses, representing the first reported successful phase 3 trial in this disorder. Satralizumab is an investigational monoclonal antibody (mAb) drug designed to target and block the interleukin-6 (IL-6) receptor.
The 44-month randomized, double-blind, placebo-controlled study enrolled adolescents and adults aged ≥12 years with MOGAD and at least 1 relapse in the prior 12 months or 2 attacks in 24 months. Participants were randomly assigned to receive subcutaneous satralizumab or placebo—with or without background immunosuppressive therapy—during a double-blind period, followed by an open-label extension in which all participants received satralizumab for up to 2 years. The primary objective was to compare MOGAD relapse prevention between groups.
Key findings as reported by Roche and Genentech include the following:
- The trial met its primary end point of preventing and/or delaying time to MOGAD relapse over the 44-month study period.
- Key secondary end points were achieved, including measures evaluating relapse prevention and clinical assessments of neurologic function.
- Satralizumab demonstrated a safety profile described as positive in an announcement from Roche and Genentech.
Satralizumab was approved by the Food and Drug Administration (FDA) in 2020 for the treatment of anti-aquaporin–4 antibody positive (AQP4+) neuromyelitis optical spectrum disorder (NMOSD) under the brand name Enspryng (satralizumab-mwge; Genentech, South San Francisco) but has not been approved for MOGAD.
Source: The MOG Project. Meteroid clinical trial. The MOG Project. Updated January 29, 2026. Accessed February 23, 2026. https://mogproject.org/clinical-trials/meteoroid-clinical-trial/