Scleroderma Clinical Trial
Official title:
A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2019 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Local Institution | Hamilton | Ontario |
Canada | Local Institution | London | Ontario |
Poland | Local Institution | Bydgoszcz | |
Poland | Local Institution | Lublin | |
Poland | Local Institution | Poznan | |
Poland | Local Institution | Szczecin | |
Poland | Local Institution | Warszawa | |
United Kingdom | Local Institution | London | Greater London |
United States | Local Institution | Albany | New York |
United States | Local Institution | Ann Arbor | Michigan |
United States | Local Institution | Aurora | Colorado |
United States | Local Institution | Baltimore | Maryland |
United States | Local Institution | Boston | Massachusetts |
United States | Local Institution | Boston | Massachusetts |
United States | Local Institution | Charleston | South Carolina |
United States | Local Institution | Chicago | Illinois |
United States | Local Institution | Cleveland | Ohio |
United States | Local Institution | Houston | Texas |
United States | Local Institution | Los Angeles | California |
United States | Local Institution | New Brunswick | New Jersey |
United States | Local Institution | New York | New York |
United States | Local Institution | New York | New York |
United States | Local Institution | Pittsburgh | Pennsylvania |
United States | Local Institution | Scottsdale | Arizona |
United States | Local Institution | Stanford | California |
United States | Local Institution | Washington | District of Columbia |
United States | Local Institution | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States, Canada, Poland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part A - Change in modified Rodnan skin score (mRSS) | Week 24 | No | |
Primary | Part B - Change in modified Rodnan skin score (mRSS) | Week 48 | No | |
Secondary | 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 | No | |
Secondary | Part A: Change in percent predicted forced vital capacity (FVC) from baseline at specified time points | Week 4, 12 and 24 | No | |
Secondary | Part A: Proportion of subjects with = 20%, 40%, or 60% change in mRSS from baseline at specified time points | Week 4, 12 and 24 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | Yes |
Secondary | 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 | Yes | |
Secondary | Part B: Change in physical function based on health assessment questionnaire-disability index (HAQ-DI) | Week 48 | No | |
Secondary | Part B: Change in percent predicted forced vital capacity | Week 48 | No | |
Secondary | 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 | No | |
Secondary | Part B: Proportion of subjects with > 10% absolute decline in % FVC | Week 48 | No | |
Secondary | Part B:Proportion of subjects with % FVC change > 0 | Week 48 | No | |
Secondary | Part B: Change in quantitative lung fibrosis (QLF) score on High resolution CT (HRCT) from baseline at specified time points | Week 48 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | Yes | |
Secondary | 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 | Yes |
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