Scleroderma
Conditions
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.
Interventions
DRUGBMS-986020
OTHERPlacebo
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 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 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 | — |
| Part B: Proportion of subjects with > 10% absolute decline in % FVC | Week 48 | — |
| Part A: Change in percent predicted forced vital capacity (FVC) from baseline at specified time points | Week 4, 12 and 24 | — |
Countries
Canada, Poland, United Kingdom, United States
Outcome results
None listed