RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Phase 1/2: Incidence and severity of adverse events (AEs)
Timeframe: Up to 28 days after CABA-201 infusion
Phase 2b Sub-study 1: Proportion of DM & ASyS subjects achieving at least a moderate Total Improvement Score (TIS) without any immunomodulatory medications and no or low dose of steroids
Timeframe: Within 16 weeks
Phase 2b Sub-study 2: Proportion of subjects with IMNM achieving at least a minimal TIS without any immunomodulatory medications and no or low dose of steroids
Timeframe: Within 24 weeks