Study of Pioglitazone in Sporadic Inclusion Body Myositis

NCT03440034 | Completed Phase 1 FDA Drug

• 1 other identifier: IRB00130996
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

IBM; inclusion body myositis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Peroxisome proliferator-activated receptor gamma coactivator 1-alpha target gene expression

  Effect of 45 milligram pioglitazone dose on the expression of Peroxisome proliferator-activated receptor gamma coactivator 1-alpha target genes

  4 weeks, 16 weeks, 32 weeks after baseline

Study Arms (1)

Pioglitazone

EXPERIMENTAL

All subjects will be provided Pioglitazone 15mg tablets, total dose of 45mg (3 tablets) for oral administration once daily. 32-week treatment period.

Drug: Pioglitazone

Interventions

Pioglitazone DRUG

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

Also known as: Actos

Pioglitazone

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years
• Must be able to ambulate at least 20 feet, with or without the use of an assistive device. Patients may not use another person, wall, or furniture for support.
• Must be able to rise from a chair without support from another person or device.
• Premenopausal women must have a negative serum pregnancy test prior to dosing with study medication.
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.

You may not qualify if:

• A history of diabetes mellitus, or prior or concurrent treatment with any diabetes therapy
• Use of chronic immunosuppressive therapy including corticosteroids or intravenous immune globulin (IVIG) within the past 6 months.
• Use of Vitamin E supplements within the past 3 months
• Creatine kinase (CK) \> 15x the upper limit of normal
• Patients receiving any medications or substances that are inhibitors or inducers of CYP2C8 are ineligible. These medications include but are not limited to Gemfibrozil, Rifampin, and warfarin.
• Pregnant women
• History of cancer less than five years prior, other than local basal or squamous cell cancer.
• Patient has any medical condition or laboratory finding during screening, which, in the investigator's opinion may interfere with participation, confound the results, or pose any additional risk to the patient.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Myositis; Myositis, Inclusion Body; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Interventions

Pioglitazone

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jemima Albayda, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, non-randomized trial in 15 patients with sIBM

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: February 20, 2018
• Study Start: May 22, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 12, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)