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Trial record 1 of 2 for:    BMS | Duchenne Muscular Dystrophy
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Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys With Duchenne Muscular Dystrophy

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT03039686
First received: January 27, 2017
Last updated: August 16, 2017
Last verified: August 2017
  Purpose
This is a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of two different weekly doses of BMS-986089 in ambulatory boys with Duchenne Muscular Dystrophy (DMD).

Condition Intervention Phase
Duchenne Muscular Dystrophy Biological: BMS-986089 Biological: Placebo for BMS-986089 Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys With Duchenne Muscular Dystrophy

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change from baseline in the 4 stair climb velocity in BMS-986089 treated participants. [ Time Frame: 48 Week ]
    Number of seconds to complete 4 stair climb.

  • Change from baseline in the 4 stair climb velocity in placebo treated participants. [ Time Frame: 48 Week ]
    Number of seconds to complete 4 stair climb.


Estimated Enrollment: 159
Actual Study Start Date: June 2, 2017
Estimated Study Completion Date: July 30, 2020
Estimated Primary Completion Date: July 30, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-986089, dose 1
Take BMS-986089 subcutaneously on specified days over a 48 week blinded period
Biological: BMS-986089
Take BMS-986089 subcutaneously on specified days over a 48 week blinded period
Experimental: BMS-986089, dose 2
Take BMS-986089 subcutaneously on specified days over a 48 week blinded period
Biological: BMS-986089
Take BMS-986089 subcutaneously on specified days over a 48 week blinded period
Placebo Comparator: Placebo
Placebo solution taken subcutaneously on specified days over a 48 week blinded period
Biological: Placebo for BMS-986089
Take placebo subcutaneously on specified days over a 48 week blinded period

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with DMD by a blood test
  • Able to walk without assistance
  • Able to walk up 4 stairs in 8 seconds or less
  • Weigh at least 15 kg (33 lbs)
  • Taking corticosteroids for DMD

Exclusion Criteria:

  • 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

Other protocol defined Inclusion/Exclusion Criteria could apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03039686

Contacts
Contact: Reference Study ID Number: WN40227 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 49 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03039686     History of Changes
Other Study ID Numbers: CN001-016
2016-001654-18 ( EudraCT Number )
WN40227 ( Other Identifier: Hoffman-La Roche )
Study First Received: January 27, 2017
Last Updated: August 16, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hoffmann-La Roche:
muscular dystrophy
Duchenne's Muscular Dystrophy
DMD

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on September 21, 2017