Clinical Trial

Phase III Trial of Sirolimus in IBM

Active, Not Recruiting Phase 3
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Summary
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2021-03-04; most recent amendment 2026-01-13.
Status change: Recruiting → Active, Not Recruiting 2025-02-12
Status change: Not Yet Recruiting → Recruiting 2022-07-08
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 2022-07-01
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-14