Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMD

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Muscular Dystrophy (DMD)

In brief

The purpose of this study is to determine the safety and tolerability of RO7239361 in boys with Duchenne Muscular Dystrophy with any genetic mutation.

Key facts

Study ID

NCT02515669

Run by

Hoffmann-La Roche

People needed

43

Starts

2015-12-02

Expected to finish

2020-04-15

Last updated by the study team

2020-11-04

Who can join

Age: 5 and older, up to 10. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with DMD
• Able to walk without assistance
• Able to walk up 4 stairs in 8 seconds or less
• Weigh at least 15 kg
• Taking corticosteroids for DMD

You may not qualify if…

• Ejection fraction < 55% on echocardiogram, based on central read
• Any behavior or mental issue that will affect the ability to complete the required study procedures
• Previously or currently taking medications like androgens or human growth hormone
• Use of a ventilator during the day
• Unable to have blood samples collected or receive an injection under the skin
• Treatment with exon skipping therapies 6 months prior to study start
• Treatment with ataluren or any investigational drug currently or within 5 half-lives prior to study start

Where it is running

• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of Florida — Gainesville, Florida, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Kennedy Krieger Institute — Baltimore, Maryland, United States
• Saint Louis Children's Hospital — St Louis, Missouri, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Alberta Children's Hospital — Calgary, Alberta, Canada
• Children'S Hospital of Eastern Ontario — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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