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History of Changes for Study: NCT03039686
Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys With Duchenne Muscular Dystrophy
Latest version (submitted November 25, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 31, 2017 None (earliest Version on record)
2 April 28, 2017 Study Status, Contacts/Locations and Outcome Measures
3 May 2, 2017 Study Status
4 June 8, 2017 Recruitment Status, Contacts/Locations, Study Status and Oversight
5 June 12, 2017 Study Status
6 August 16, 2017 Contacts/Locations, Study Identification, Sponsor/Collaborators and Study Status
7 October 12, 2017 Contacts/Locations and Study Status
8 November 14, 2017 Study Status, References and Contacts/Locations
9 December 4, 2017 Study Status
10 January 8, 2018 Contacts/Locations and Study Status
11 January 19, 2018 Recruitment Status, Study Status and Contacts/Locations
12 February 13, 2018 Study Status
13 May 3, 2018 Recruitment Status, Study Status and Contacts/Locations
14 June 4, 2018 Study Status and Contacts/Locations
15 July 10, 2018 Arms and Interventions, Study Status, Outcome Measures, Study Identification, References, Contacts/Locations, Eligibility and Study Description
16 August 8, 2018 Contacts/Locations and Study Status
17 September 6, 2018 Contacts/Locations and Study Status
18 November 15, 2018 Outcome Measures, Contacts/Locations, Study Status and Eligibility
19 February 15, 2019 Contacts/Locations and Study Status
20 March 18, 2019 Study Status and Contacts/Locations
21 April 17, 2019 Study Status
22 June 3, 2019 Contacts/Locations and Study Status
23 October 25, 2019 Recruitment Status, Contacts/Locations, Study Status and Study Design
24 February 4, 2020 Study Status and Contacts/Locations
25 May 13, 2020 Recruitment Status, Study Status and Contacts/Locations
26 October 21, 2020
Quality Control Review has not concluded Returned: November 13, 2020
Recruitment Status, Outcome Measures, Study Status, Arms and Interventions, Document Section
27 November 25, 2020 Study Status, Adverse Events, Outcome Measures, Baseline Characteristics
Comparison Format:

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Study NCT03039686
Submitted Date:  January 31, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: CN001-016
Brief Title: Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys With Duchenne Muscular Dystrophy
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
Secondary IDs: 2016-001654-18 [EudraCT Number]
Open or close this module Study Status
Record Verification: January 2017
Overall Status: Not yet recruiting
Study Start: March 30, 2017
Primary Completion: July 30, 2020 [Anticipated]
Study Completion: July 30, 2020 [Anticipated]
First Submitted: January 27, 2017
First Submitted that
Met QC Criteria:
January 31, 2017
First Posted: February 1, 2017 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 31, 2017
Last Update Posted: February 1, 2017 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bristol-Myers Squibb
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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).
Detailed Description:
Open or close this module Conditions
Conditions: Duchenne Muscular Dystrophy
Keywords: muscular dystrophy
Duchenne's Muscular Dystrophy
DMD
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 159 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from baseline in the 4 stair climb velocity in BMS-986089 treated participants.
[ Time Frame: 48 Week ]

2. Change from baseline in the 4 stair climb velocity in placebo treated participants.
[ Time Frame: 48 Week ]

Open or close this module Eligibility
Minimum Age: 6 Years
Maximum Age: 11 Years
Sex: Male
Gender Based:
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.

Open or close this module Contacts/Locations
Central Contact Person: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email: Clinical.Trials@bms.com
Central Contact Backup: First line of the email MUST contain NCT# and Site #.
Study Officials: Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: BMS Clinical Trial Education Resource
Description: FDA Safety Alerts and Recalls
Available IPD/Information:

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