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Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMD
Muscle And Peripheral Nerve Disease Muscular Dystrophy Duchenne Muscular Dystrophy (DMD)
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 1/Phase 2
Trial Identifier
NCT02515669, CN001-006, WN40226
Condition
Muscular Dystrophy (DMD)
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
Study Summary
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 Criteria
Male
≥5 Years & ≤ 10 Years
No
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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com