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

Muscle And Peripheral Nerve Disease
Muscular Dystrophy
Duchenne Muscular Dystrophy (DMD)

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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

Gender

Male

Age

≥5 Years & ≤ 10 Years

Healthy Volunteers

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

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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

For the latest version of this information please go to www.forpatients.roche.com