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

TerminatedPhase 1, Phase 2

Sponsor: Hoffmann-La Roche

Conditions: Muscular Dystrophy (DMD)

Interventions: RO7239361, Placebo

Countries: United States, Canada

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

Eligibility overview

Sex: MALE

Age: 5 Years to 10 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (12)

Los Angeles, California, United States
Palo Alto, California, United States
Gainesville, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
Cincinnati, Ohio, United States
Calgary, Alberta, Canada
Ottawa, Ontario, Canada