A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants With Pulmonary Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 403
- 试验地点
- 119
- 主要终点
- Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in IPF Participants
研究概览
简要总结
The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the idiopathic pulmonary fibrosis (IPF) Cohort
- •Diagnosis of IPF within 7 years of screening
- •Female and males ≥ 40 years of age
- •For the progressive fibrotic interstitial lung disease (PF-ILD) Cohort
- •Evidence of progressive ILD within the 24 months before screening
- •Female and male ≥ 21 years of age.
排除标准
- •Women of childbearing potential (WOCBP)
- •Active Smokers
- •Current malignancy or previous malignancy up to 5 years prior to screening
- •History of allergy to BMS-986278 or related compounds
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
IPF Dose 1 + Post Treatment Follow-up or OTE
IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)
干预措施: BMS-986278 (Drug)
IPF Dose 2 + Post Treatment Follow-up or OTE
干预措施: BMS-986278 (Drug)
IPF Placebo + Post Treatment Follow-up or OTE
干预措施: BMS-986278 Placebo (Other)
PF-ILD Dose 1 + Post Treatment Follow-up or OTE
PF-ILD (Progressive Fibrotic Interstitial Lung Disease)
干预措施: BMS-986278 (Drug)
PF-ILD Dose 2 + Post Treatment Follow-up or OTE
干预措施: BMS-986278 (Drug)
PF-ILD Placebo + Post Treatment Follow-up or OTE
干预措施: BMS-986278 Placebo (Other)
结局指标
主要结局
Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in IPF Participants
时间窗: From baseline (first dose) up to week 26
Percent predicted forced vital capacity (ppFVC) is the percentage of predicted value per participant of forced vital capacity (FVC). FVC is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. The data is reported as percent change from baseline in ppFVC. Percent change from baseline is a calculation that expresses the change in a value compared to its initial starting point (baseline) as a percentage, showing how much a value has increased or decreased relative to its original level; it's calculated by subtracting the baseline value from the new value, dividing by the baseline value, and then multiplying by 100%. The percent change in this endpoint was calculated from ppFVC values taken at baseline, which is defined as the measurement of ppFVC taken at first dose, and ppFVC values taken at Week 26. This endpoint reports data for the IPF cohort only as pre-specified in the protocol.
次要结局
- The Number of Participants Experiencing Adverse Events (AEs)(From first dose up to 30 days after last dose during the main study treatment phase)
- The Number of Participants Experiencing Serious Adverse Events (SAEs)(From first dose up to 30 days after last dose during the main study treatment phase)
- The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation(From first dose up to 30 days after last dose during the main study treatment phase)
- The Number of Participants Who Died Due to Adverse Events (AEs)(From first dose up to 30 days after last dose during the main study treatment phase)
- Maximum Concentration (Cmax)(On Day 1 and Week 4 (Day 29))
- Time to Maximum Concentration (Tmax)(On Day 1 and Week 4 (Day 29))
- Area Under Curve (AUC0-8)(On Day 1 and Week 4 (Day 29))
- Concentration Trough (Ctrough)(On Week 4 (Day 29) and Week 12 (Day 85))
- The Number of Participants Experiencing Electrocardiogram (ECG) Abnormalities(At Week 26)
- Change From Baseline in Vital Sign Measurements(At baseline and Week 26)
- Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in PF-ILD Participants(At baseline and Week 26)
- The Number of Participants With ≥ 10% Absolute Decline in ppFVC (%)(At Weeks 4, 8, 12, 16, 20, and 26)
- The Number of Participants With 0% Change in ppFVC (%)(Weeks 4, 8, 12, 16, 20, and 26)
- Time to First Occurrence ≥ 10% Absolute Decline in ppFVC (%)(From first dose up to the first occurrence of ≥ 10% absolute decline in ppFVC)
- Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC)(From baseline up to Weeks 4, 8, 12, 16, 20, and 26)
- Absolute Change From Baseline in Forced Vital Capacity (FVC)(From baseline up to Weeks 4, 8, 12, 16, 20, and 26)
- Absolute Change From Baseline in Single Breath Diffusing Capacity of Carbon Monoxide (DLCO SB)(From baseline up to Week 26)
- Absolute Change From Baseline in Percent Predicted Single Breath Diffusing Capacity of Carbon Monoxide (ppDLCO SB)(From baseline up to Week 26)
- Absolute Change From Baseline in Walking Endurance/Distance(From baseline up to Week 26)
- Time to First Acute Exacerbation(From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first)
- The Number of Participants Experiencing Acute Exacerbation(From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first)