Study of Arimoclomol in Inclusion Body Myositis (IBM)

Completed · Phase 2 · Has a placebo group

Conditions studied: Inclusion Body Myositis

In brief

Funding Source - FDA Office of Orphan Products Development (OOPD). The purpose of this study is to evaluate the safety and efficacy of the study drug, arimoclomol in IBM patients.

Key facts

Study ID

NCT02753530

Run by

ZevraDenmark

People needed

152

Starts

2017-08-16

Expected to finish

2021-01-11

Last updated by the study team

2023-05-10

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet any of the European Neuromuscular Centre Inclusion Body Myositis research diagnostic criteria 2011 categories for IBM.
• Demonstrate being able to arise from a chair without support from another person or device.
• Able to ambulate at least 20 ft/6 meters with or without assistive device. Once arisen from the chair, participant may use any walking device, i.e. walker/frame, can, crutches, or braces. They cannot be supported by another person and cannot use furniture or wall for support.
• Age at onset of weakness >45 years.
• Body weight of >= 40 kg.
• Able to give informed consent.

You may not qualify if…

• History of any of the following excludes subject participation in the study: chronic infection particularly HIV or Hepatitis B or C; cancer other than basal cell cancer less than five years prior; or other chronic serious medical illnesses.
• Presence of any of the following on routine blood screening: White blood cells (WBC) <3000; platelets < 100,000; hematocrit <30%; blood urea nitrogen (BUN) >30 mg/dL; creatinine >1.5 x upper limit of normal; symptomatic liver disease with serum albumin <3 g/dL.
• History of most recent creatine kinase >15x the upper limit of normal without any other explanation besides IBM.
• History of non-compliance with other therapies.
• Use of testosterone except for physiologic replacement doses in case of androgen deficiency. Participants must have documented proof of the androgen deficiency.
• Coexistence of other disease that would be likely to affect outcome measures
• Drug or alcohol abuse within past three months.
• Participation in a recent drug study in the last 30 days prior to the screening visit or use of a biologic agent less than 6 months prior to the screening visit.
• Women who are lactating or unwilling to use adequate method of birth control who are not surgically sterile. Adequate birth control includes use of intrauterine device, abstinence, or oral contraceptives or a double barrier method, e.g condom plus diaphragm will be necessary for both male and female participants.
• Participants taking >7.5 mg prednisolone or equivalent or participants on Intravenous Immunoglobulin Therapy (IVIg) or other immunosuppressants within the last 3 months.
• Clinically significant renal or hepatic disease, as indicated by clinical laboratory assessment.

Where it is running

• Phoenix Neurological Associates — Phoenix, Arizona, United States
• University of California, Irvine — Irvine, California, United States
• University of Colorado School of Medicine — Aurora, Colorado, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Rochester — Rochester, New York, United States
• The Ohio State University — Columbus, Ohio, United States
• Nerve and Muscle Center of Texas — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Virginia — Charlottesville, Virginia, United States
• University College of London — London, United Kingdom

Full record on ClinicalTrials.gov

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