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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - BMS-986020 | Experimental | BMS-986020 or Placebo tablets specified dose on specified days |
|
| Part B - BMS-986020 | Experimental | BMS-986020 or Placebo tablets specified dose on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986020 | Drug |
| ||
| Placebo |
| 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 |
| 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 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Scottsdale | Arizona | 85259 | United States | ||
| Local Institution |
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| Other |
|
| 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 |
| Los Angeles |
| California |
| 90095 |
| United States |
| Local Institution | Stanford | California | 94305 | United States |
| Local Institution | Aurora | Colorado | 80045 | United States |
| Local Institution | Washington D.C. | District of Columbia | 20037 | United States |
| Local Institution | Washington D.C. | District of Columbia | 20057 | United States |
| Local Institution | Chicago | Illinois | 60611 | United States |
| Local Institution | Baltimore | Maryland | 21205 | United States |
| Local Institution | Boston | Massachusetts | 02114 | United States |
| Local Institution | Boston | Massachusetts | 02118 | United States |
| Local Institution | Ann Arbor | Michigan | 48109 | United States |
| Local Institution | New Brunswick | New Jersey | 08903 | United States |
| Local Institution | Albany | New York | 12206 | United States |
| Local Institution | New York | New York | 10021 | United States |
| Local Institution | New York | New York | 10032 | United States |
| Local Institution | Cleveland | Ohio | 44195 | United States |
| Local Institution | Pittsburgh | Pennsylvania | 15219 | United States |
| Local Institution | Charleston | South Carolina | 29425 | United States |
| Local Institution | Houston | Texas | 77030 | United States |
| Local Institution | Hamilton | Ontario | L8N 1Y2 | Canada |
| Local Institution | London | Ontario | N6A 4L6 | Canada |
| Local Institution | Bydgoszcz | 85-681 | Poland |
| Local Institution | Lublin | 20-954 | Poland |
| Local Institution | Poznan | 60-218 | Poland |
| Local Institution | Szczecin | 71-252 | Poland |
| Local Institution | Warsaw | 02-507 | Poland |
| Local Institution | London | Greater London | NW3 2QG | United Kingdom |
| ID | Term |
|---|---|
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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