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Phase III Trial of Sirolimus in IBM

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 1, 2026 to Dec 2027 Study sites: 9 to 10v10 Show 1 more changeShow less
    • Study sites: 9 to 10
  2. Trial status: Recruiting to Active, Not Recruiting Primary and study completion dates: Sep 1, 2026 to Dec 1, 2026 · Site details revised at 9 of 9 sitesv9 Show 2 more changesShow less
    • Primary and study completion dates: Sep 1, 2026 to Dec 1, 2026
    • Site details revised at 9 of 9 sites
  3. Primary and study completion dates: Feb 1, 2024 to Sep 1, 2026 Site details revised at 9 of 9 sitesv8 Show 1 more changeShow less
    • Site details revised at 9 of 9 sites
  4. Site details revised at 1 of 9 sitesv7
  5. Primary and study completion dates: Nov 1, 2023 to Feb 1, 2024v6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 9v5 Show 1 more changeShow less
    • Study sites: 1 to 9
  2. Start date: Jan 1, 2022 to Jul 1, 2022v4
  3. Start date: Sep 1, 2021 to Jan 1, 2022v3
  4. Start date: Jul 1, 2021 to Sep 1, 2021 Study sites: 0 to 1 · Primary and study completion dates: Sep 1, 2023 to Nov 1, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Primary and study completion dates: Sep 1, 2023 to Nov 1, 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The hypothesis is that Sirolimus, (Rapamycin (R)) which is currently used in organ transplantation and works by blocking the activity of T effector cells but preserving T regulatory cells, as well as by inducing autophagy (protein degradation), will be effective in IBM to slow or stabilize disease progression, helping to maintain patient function and independence. This phase III trial will confirm pilot data showing statistically significant clinical outcomes.
Trial Details
NCT Number NCT04789070
Lead Sponsor University of Kansas Medical Center
Collaborators: The Perron Institute
Conditions Inclusion Body Myositis
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov