A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
- Registration Number
- NCT02588625
- Lead Sponsor
- Bristol-Myers Squibb
- 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 available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A - BMS-986020 BMS-986020 BMS-986020 or Placebo tablets specified dose on specified days Part A - BMS-986020 Placebo BMS-986020 or Placebo tablets specified dose on specified days Part B - BMS-986020 BMS-986020 BMS-986020 or Placebo tablets specified dose on specified days Part B - BMS-986020 Placebo BMS-986020 or Placebo tablets specified dose on specified days
- Primary Outcome Measures
Name Time Method Part B - Change in modified Rodnan skin score (mRSS) Week 48 Part A - Change in modified Rodnan skin score (mRSS) Week 24
- Secondary Outcome Measures
Name Time Method Part A: Change in physical function based on health assessment questionnaire-disability index from baseline at specified timepoints (HAQ-DI) Week 4, 12 and 24 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 up to Month 3 of the Follow-Up Part B: Change in percent predicted forced vital capacity Week 48 Part B:Proportion of subjects with ≥ 20%, 40%, or 60% change in mRSS from baseline at specified time points Week 4, 12, 24, 36, and 48 Part B: Proportion of subjects with > 10% absolute decline in % FVC Week 48 Part B:Proportion of subjects with % FVC change > 0 Week 48 Part B: Change in quantitative lung fibrosis (QLF) score on High resolution CT (HRCT) from baseline at specified time points Week 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 Week 4, 12, 24, 36, and 48 Part A: Proportion of subjects with ≥ 20%, 40%, or 60% change in mRSS from baseline at specified time points 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 Week 4, 12 and 24 Part A: Change in percent predicted forced vital capacity (FVC) from baseline at specified time points 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 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 up to Month 3 of the Follow-Up Serious adverse event (SAE), Adverse event (AE)
Part B: Change in physical function based on health assessment questionnaire-disability index (HAQ-DI) Week 48 Part B: Change in subject's global assessment on a visual analog scale (VAS) from baseline at specified time points 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 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 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 up to Month 3 of the Follow-Up
Trial Locations
- Locations (1)
Local Institution
🇬🇧London, Greater London, United Kingdom