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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Scleroderma

Intervention / Treatment
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* Drug: BMS-986020
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A - BMS-986020<br>BMS-986020 or Placebo tablets specified dose on specified days | Drug: BMS-986020<br> <br> Other: Placebo<br> <br> |
| Experimental: Part B - BMS-986020<br>BMS-986020 or Placebo tablets specified dose on specified days | Drug: BMS-986020<br> <br> Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A - Change in modified Rodnan skin score (mRSS) |  | Week 24 | 
| Part B - Change in modified Rodnan skin score (mRSS) |  | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: Change in percent predicted forced vital capacity (FVC) from baseline at specified time points |  | Week 4, 12 and 24 | 
| 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 subject's global assessment on a visual analog scale (VAS) 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: 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 | Serious adverse event (SAE), Adverse event (AE) | up to Month 3 of the Follow-Up | 
| 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 physical function based on health assessment questionnaire-disability index (HAQ-DI) |  | Week 48 | 
| 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 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: 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 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 |