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

Trial ID or NCT#

NCT02515669,25513,26554

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

A Multi-Site, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7239361 (BMS-986089) in Ambulatory Boys With Duchenne Muscular Dystrophy

Eligibility Criteria

Ages Eligible for Study: 5 Years to 10 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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