NCT02588625撤回2 期
A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Part B - Change in modified Rodnan skin score (mRSS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Limited cutaneous systemic sclerosis or sine scleroderma
- •Active ulcers on fingers
- •Pulmonary arterial hypertension
- •Any gastrointestinal surgery that may impact absorption of study drug
研究组 & 干预措施
Part A - BMS-986020
Experimental
BMS-986020 or Placebo tablets specified dose on specified days
干预措施: BMS-986020 (Drug)
Part A - BMS-986020
Experimental
BMS-986020 or Placebo tablets specified dose on specified days
干预措施: Placebo (Other)
Part B - BMS-986020
Experimental
BMS-986020 or Placebo tablets specified dose on specified days
干预措施: BMS-986020 (Drug)
Part B - BMS-986020
Experimental
BMS-986020 or Placebo tablets specified dose on specified days
干预措施: Placebo (Other)
结局指标
主要结局
Part B - Change in modified Rodnan skin score (mRSS)
时间窗: Week 48
Part A - Change in modified Rodnan skin score (mRSS)
时间窗: Week 24
次要结局
- 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)
- 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)
研究者
研究点 (1)
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