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A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)

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ClinicalTrials.gov Identifier: NCT02588625
Recruitment Status : Withdrawn
First Posted : October 28, 2015
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 26, 2015
First Posted Date  ICMJE October 28, 2015
Last Update Posted Date July 22, 2016
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
  • Part A - Change in modified Rodnan skin score (mRSS) [ Time Frame: Week 24 ]
  • Part B - Change in modified Rodnan skin score (mRSS) [ Time Frame: Week 48 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02588625 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
  • Part A: Change in physical function based on health assessment questionnaire-disability index from baseline at specified timepoints (HAQ-DI) [ Time Frame: Week 4, 12 and 24 ]
  • Part A: Change in percent predicted forced vital capacity (FVC) from baseline at specified time points [ Time Frame: Week 4, 12 and 24 ]
  • Part A: Proportion of subjects with ≥ 20%, 40%, or 60% change in mRSS from baseline at specified time points [ Time Frame: Week 4, 12 and 24 ]
  • Part A: Change in subject's global assessment on a visual analog scale (VAS) from baseline at specified time points [ Time Frame: Week 4, 12 and 24 ]
  • Part A: Change in physician's global assessment on a visual analog scale (VAS) from baseline at specified time points [ Time Frame: Week 4, 12 and 24 ]
  • Part A: Safety as measured by the frequency of deaths, SAEs, drug related AEs, AEs leading to discontinuation as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations [ Time Frame: up to Month 3 of the Follow-Up ]
    Serious adverse event (SAE), Adverse event (AE)
  • Part A: Tolerability as measured by the frequency of deaths, SAEs, drug related AEs, AEs leading to discontinuation as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations [ Time Frame: up to Month 3 of the Follow-Up ]
  • Part B: Change in physical function based on health assessment questionnaire-disability index (HAQ-DI) [ Time Frame: Week 48 ]
  • Part B: Change in percent predicted forced vital capacity [ Time Frame: Week 48 ]
  • Part B:Proportion of subjects with ≥ 20%, 40%, or 60% change in mRSS from baseline at specified time points [ Time Frame: Week 4, 12, 24, 36, and 48 ]
  • Part B: Proportion of subjects with > 10% absolute decline in % FVC [ Time Frame: Week 48 ]
  • Part B:Proportion of subjects with % FVC change > 0 [ Time Frame: Week 48 ]
  • Part B: Change in quantitative lung fibrosis (QLF) score on High resolution CT (HRCT) from baseline at specified time points [ Time Frame: Week 48 ]
  • Part B: Change in subject's global assessment on a visual analog scale (VAS) from baseline at specified time points [ Time Frame: Week 4, 12, 24, 36, and 48 ]
  • Part B: Change in physician's global assessment on a visual analog scale (VAS) from baseline at specified time points [ Time Frame: Week 4, 12, 24, 36, and 48 ]
  • Part B: Change in health-related quality of life (HRQOL) using Patient Reported Outcomes Measurement Information System (PROMIS)-29 score from baseline at specified time points [ Time Frame: Week 4, 12, 24, 36, and 48 ]
  • Part B: Safety as measured by the frequency of deaths, SAEs, drug related AEs, AEs leading to discontinuation as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations [ Time Frame: up to Month 3 of the Follow-Up ]
  • Part B: Tolerability as measured by the frequency of deaths, SAEs, drug related AEs, AEs leading to discontinuation as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations [ Time Frame: up to Month 3 of the Follow-Up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Official Title  ICMJE A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Brief Summary

This is a two part study.

The purpose of Part A is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using one dose of BMS-986020.

The purpose of Part B is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using two different doses of BMS-986020.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Scleroderma
Intervention  ICMJE
  • Drug: BMS-986020
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Part A - BMS-986020
    BMS-986020 or Placebo tablets specified dose on specified days
    Interventions:
    • Drug: BMS-986020
    • Other: Placebo
  • Experimental: Part B - BMS-986020
    BMS-986020 or Placebo tablets specified dose on specified days
    Interventions:
    • Drug: BMS-986020
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 14, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2015)
247
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Inclusion Criteria:

  • Diagnosis of diffuse cutaneous systemic sclerosis for 60 months or less
  • Men and women ≥ 18 years of age
  • Ability to comply with birth control requirements
  • Certain immunosuppressive agents are permitted

Exclusion Criteria:

  • Limited cutaneous systemic sclerosis or sine scleroderma
  • Active ulcers on fingers
  • Pulmonary arterial hypertension
  • Any gastrointestinal surgery that may impact absorption of study drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Poland,   United Kingdom,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT02588625
Other Study ID Numbers  ICMJE IM136-132
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date July 2016

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