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

  • Muscle And Peripheral Nerve Disease
  • Muscular Dystrophy
  • Duchenne Muscular Dystrophy (DMD)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Terminated

This trial runs in
Countries
  • Canada
  • United States
Trial Identifier:

NCT02515669 WN40226 CN001-006

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

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 1/Phase 2 Phase
      NCT02515669, CN001-006, WN40226 Trial Identifier
      RO7239361, Placebo Treatments
      Muscular Dystrophy (DMD) Condition
      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

      Male Gender
      ≥5 Years & ≤ 10 Years Age
      No 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

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

       

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