Clinical Trial TitleA multi-site, randomized, placebo-controlled, double-blind, multiple ascending subcutaneous dose study to evaluate the safety, tolerability and pharmacokinetics of BMS-986089 in ambulatory boys with Duchenne muscular dystrophy.
Clinical Trial Protocol Description:
The purpose of this study is to assess the safety and tolerability of an anti-myostatin adnectin called BMS-986089 in ambulatory boys with genetically confirmed Duchenne muscular dystrophy (DMD).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Be male, 5 to 10 years old and ambulatory without assistance.
- Weigh at least 15 kg.
- Have a diagnosis of DMD, confirmed by genotyping.
- Are receiving corticosteroids (eg, prednisone, prednisolone, or deflazacort) for at least 6 months prior to the start of study drug administration.
You will be excluded from the study if any of the following criteria apply to you:
- Have a history of current renal disease.
- Have ejection fraction < 55% on screening echocardiogram.
- Have known cognitive impairment or behavioral issues that will compromise ability to comply with study procedure.
- Have uncontrolled clinical signs and symptoms of chronic heart failure (American College of Cardiology/American Heart Associated Stage C or D).
This is a partial list of inclusion and exclusion criteria.
Clinical Trial Investigator
Peter T. Heydemann, MD
RUSH University Medical Center
1620 W Harrison St
Chicago, IL 60612