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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Bristol-Myers Squibb

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Bristol-Myers Squibb

Dates:
Date Received: October 26, 2015
Date Started: February 2016
Date Completion: October 2019
Last Updated: July 20, 2016
Last Verified: July 2016