Clinical trials / NCT06154252
NCT06154252Phase 2, phase 3Recruiting

RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Study sponsor: Cabaletta Bio

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2028-07Estimated
Enrollment · participants74Estimated
Source updated2026-09-17Last update listed in the registry record
Version history

Changes to this trial

Last 12 months
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· 3 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: To evaluate adverse events reported by subjects

+ After

Measure: Phase 1/2: Incidence and severity of adverse events (AEs) Measure: 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 Measure: 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

Planned enrollment increased by 50 participants

− Before

24 participants (planned)

+ After

74 participants (planned)

Phase changed

− Before

PHASE1, PHASE2

+ After

PHASE2, PHASE3

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