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Clinical Trial Summary

A study looking at the effect of pioglitazone in skeletal muscle of patients with sporadic inclusion body myositis (sIBM).


Clinical Trial Description

This is a 52-week, Phase 1, open-label, single center, proof of concept study of FDA-approved pioglitazone in adult patients with sporadic inclusion body myositis (sIBM). The trial consists of a 4-week screening period;16-week "lead-in" period during which all subjects are observed off-treatment. At Week 16, all subjects will be started on pioglitazone at a dose of 30 mg daily. The dose will be uptitrated to a goal dose of 45 mg daily after 2 weeks; 32-week treatment period with all subjects on 45 mg daily dose of pioglitazone. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03440034
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase Phase 1
Start date May 22, 2018
Completion date December 31, 2020

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