NCT03440034

Study of Pioglitazone in Sporadic Inclusion Body Myositis

An Open-Label Pilot Study of Pioglitazone in Sporadic Inclusion Body Myositis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Myositis
• Inclusion Body Myositis
• Muscular Diseases
• Musculoskeletal Disease
• Neuromuscular Diseases
• Nervous System Diseases

Interventions

Type	Name	Description
DRUG	Pioglitazone	Pioglitazone comes as a tablet to take by mouth and can be taken with or without food.

Timeline

• Start date: 2018-05-22
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-02-20
• Last updated: 2021-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study