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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02515669
Recruitment Status : Active, not recruiting
First Posted : August 5, 2015
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

July 29, 2015
August 5, 2015
April 25, 2018
December 2, 2015
February 8, 2018   (Final data collection date for primary outcome measure)
  • Safety and Tolerability based on number of incidences of AEs, serious AEs, AEs leading to discontinuation and death, as well as marked treatment emergent abnormalities in clinical laboratory tests [ Time Frame: 24 weeks ]
    Adverse event (AEs)
  • Safety and Tolerability based on number of incidences of vital sign measurements, ECGs, echocardiograms, and physical examinations [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT02515669 on ClinicalTrials.gov Archive Site
  • Trough concentrations of BMS-986089 [ Time Frame: Day 8 through Week 24 ]
  • Maximum observed concentration (Cmax) of BMS-986089 [ Time Frame: Day 1 and 29 ]
  • Frequency of subjects with positive anti-BMS-986089 antibodies (ADA) assessment [ Time Frame: Day 8 through Week 24 ]
  • Frequency of subjects who develop positive ADA following a negative baseline [ Time Frame: Day 8 through Week 24 ]
  • Anti-BMS-986089 antibodies on selected days [ Time Frame: Day 8 through Week 24 ]
  • Serum concentration of free myostatin [ Time Frame: Day 8 through Week 24 ]
  • Change from baseline in volume of thigh muscle contractile and non-contractile tissue [ Time Frame: Day 8 through Week 24 ]
  • Change from baseline in thigh muscle maximal cross sectional area [ Time Frame: Day 8 through Week 24 ]
  • Serum concentration of drug-myostatin complex [ Time Frame: Day 8 through Week 24 ]
  • Serum concentration of percent inhibition of free myostatin at trough [ Time Frame: Day 8 through Week 24 ]
  • Trough concentrations of BMS-986089 [ Time Frame: Day 8 through Week 24 ]
  • Maximum observed concentration (Cmax) of BMS-986089 [ Time Frame: Day 1 and 29 ]
  • Frequency of subjects with positive anti-BMS-986089 antibodies (ADA) assessment [ Time Frame: Day 8 through Week 24 ]
  • Frequency of subjects who develop positive ADA following a negative baseline [ Time Frame: Day 8 through Week 24 ]
  • Anti-BMS-986089 antibodies on selected days [ Time Frame: Day 8 through Week 24 ]
  • Serum concentration of free myostatin [ Time Frame: Day 8 through Week 24 ]
  • Change from baseline in volume of thigh muscle contractile and non-contractile tissue [ Time Frame: Day 8 through Week 24 ]
  • Change from baseline in thigh muscle lipid fraction [ Time Frame: Day 8 through Week 24 ]
  • Change from baseline in thigh muscle maximal cross sectional area [ Time Frame: Day 8 through Week 24 ]
  • Serum concentration of drug-myostatin complex [ Time Frame: Day 8 through Week 24 ]
  • Serum concentration of percent inhibition of free myostatin at trough [ Time Frame: Day 8 through Week 24 ]
Not Provided
Not Provided
 
Study of an Investigational Drug, BMS-986089, in Ambulatory Boys With DMD
A Multi-site, Randomized, Placebo-controlled, Double-blind, Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety Tolerability and Pharmacokinetics of BMS-986089 in Ambulatory Boys With Duchenne Muscular Dystrophy
The purpose of this study is to determine the safety and tolerability of BMS-986089 in boys with Duchenne Muscular Dystrophy with any genetic mutation.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Muscular Dystrophy (DMD)
  • Biological: BMS-986089
    Other Name: Anti-Myostatin Adnectin
  • Biological: Placebo
  • Active Comparator: BMS-986089
    BMS-986089 subcutaneous injections on specified days
    Intervention: Biological: BMS-986089
  • Placebo Comparator: Placebo
    Placebo subcutaneous injections on specified days
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
Same as current
August 4, 2020
February 8, 2018   (Final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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
  • 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
Sexes Eligible for Study: Male
5 Years to 10 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT02515669
CN001-006
WN40226 ( Other Identifier: Hoffman-La Roche )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP