NCT06003426进行中（未招募）3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
Bristol-Myers Squibb390 个研究点 分布在 1 个国家目标入组 1,255 人开始时间: 2023年9月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,255
- 试验地点
- 390
- 主要终点
- Number of participants that experience spontaneous syncopal events
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with IPF aged ≥ 40 years at the time of signing the informed consent.
- •Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia.
- •If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
- •If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
- •Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
- •Men who are sexually active with women of childbearing potential agree to use male barrier contraception.
排除标准
- •History of stroke or transient ischemic attack within 3 months prior to screening.
- •Participants who exhibit symptoms of heart failure at rest.
- •Participants who have a current malignancy or a previous malignancy with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
- •Other protocol-defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
BMS-986278 Dose 1
Experimental
干预措施: BMS-986278 (Drug)
BMS-986278 Dose 2
Experimental
干预措施: BMS-986278 (Drug)
BMS-986278 Placebo
Placebo Comparator
干预措施: BMS-986278 Placebo (Drug)
结局指标
主要结局
Number of participants that experience spontaneous syncopal events
时间窗: At approximately 4 weeks
Cohort 1
Absolute change from baseline in forced vital capacity (FVC) measured in mL
时间窗: Up to Week 52
Cohort 2
次要结局
- Number of participants who discontinued treatment due to any low BP-related Adverse Events(Up to approximately 3 years)
- Disease progression(Up to approximately 3 years)
- Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score(Up to Week 52)
- Change from baseline in L-PF dyspnea domain score(Up to Week 52)
- Change from baseline in walking distance measured in 6-minute walk test (6MWT)(Up to Week 52)
- Time to the first occurrence of any of the components of the composite endpoint: time to first acute exacerbation of pulmonary fibrosis, first Respiratory-related hospitalization, or all-cause mortality(Up to approximately 3 years)
- Time to absolute percent ppFVC decline of ≥ 10% from baseline(Up to approximately 3 years)
- Time to first acute exacerbation of pulmonary fibrosis(Up to approximately 3 years)
- Time to first Respiratory-related hospitalization(Up to approximately 3 years)
- Time to first pulmonary fibrosis-related hospitalization(Up to approximately 3 years)
- Time to death(Up to approximately 3 years)
- Change from baseline in L-PF fatigue domain score(Up to Week 52)
- Change from baseline in L-PF impacts module score(Up to Week 52)
- Change from baseline in cough numeric rating scale (NRS)(Up to Week 52)
- Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score(Up to Week 52)
- Change from baseline in EQ-5D-5L visual analog scale score(Up to Week 52)
- Rate of decline from baseline in FVC (mL)(Up to Week 52)
- Rate of decline in ppFVC from baseline(Up to Week 52)
- Change in ppFVC from baseline(Up to Week 52)
- Proportion of participants with absolute decline in ppFVC ≥10%(Up to Week 52)
- Proportion of participants with relative decline in ppFVC ≥10%(Up to Week 52)
- Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg)(Up to Week 52)
- Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline(Up to Week 52)
- Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)(Up to Week 52)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 28 days after last dose)
- Number of participants with vital sign abnormalities(Up to 28 days after last dose)
- Number of participants with Adverse Events (AEs)(Up to 28 days after last dose)
- Number of participants with Serious AEs (SAEs)(Up to 28 days after last dose)
- Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP)(Up to 28 days after last dose)
- Number of participants with AEs related to IMP(Up to 28 days after last dose)
- Number of treatment-emergent deaths(Up to 28 days after last dose)
- Number of participants with clinical laboratory abnormalities(Up to 28 days after last dose)
研究者
研究点 (390)
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