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Phase III Trial of Sirolimus in IBM

Inclusion Body Myositis Clinical Trial

Official title:
A Double-Blind Randomised Controlled Trial (dbRCT) Phase III Trial Investigating the Effect of Sirolimus on Disease Progression in Patients With Inclusion Body Myositis (IBM) as Measured by the IBM Functional Rating Scale (IBM-FRS)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04789070
Study type Interventional
Source University of Kansas Medical Center
Contact Andrew J Heim
Phone 9139459926
Email aheim2@kumc.edu
Status Recruiting
Phase Phase 3
Start date July 1, 2022
Completion date February 1, 2024
View Details
See also
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