NCT06025578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 Progressive Pulmonary Fibrosis
Bristol-Myers Squibb835 个研究点 分布在 1 个国家目标入组 1,057 人开始时间: 2023年10月25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
- 1,057
- 试验地点
- 835
- 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 Progressive 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
- •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.
- •Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening.
- •Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
- •Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken 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
- •Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
- •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; a previous malignancy with less than 2 years free of recurrence; and a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
- •Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study.
- •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: At Week 52
Cohort 2
次要结局
- Time to first pulmonary fibrosis-related hospitalization.(Up to approximately 3 years)
- Change from baseline in L-PF impacts module score(At Week 52 and up to approximately 3 years)
- Time to all-cause mortality(Up to approximately 3 years)
- Number of participants who discontinued treatment due to any low BP-related Adverse Events(Up to approximately 3 years)
- Change from baseline in L-PF fatigue domain score(At Week 52 and up to approximately 3 years)
- Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score(At Week 52)
- Rate of decline in ppFVC from baseline(At Week 52)
- Proportion of participants with relative decline in ppFVC ≥10%(At Week 52)
- Disease progression(Up to approximately 3 years)
- Change from baseline in L-PF dyspnea domain score(At Week 52 and up to approximately 3 years)
- Change from baseline in walking distance measured in 6-minute walk test (6MWT)(At 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)
- Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score(At Week 52 and 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)
- Rate of decline from baseline in FVC (mL)(At Week 52)
- Change from baseline in EQ-5D-5L visual analog scale score(At Week 52)
- Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline(At Week 52)
- Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)(At Week 52)
- 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 electrocardiogram (ECG) abnormalities(Up to 28 days after last dose)
- Change from baseline in cough numeric rating scale (NRS)(At Week 52 and up to approximately 3 years)
- Change in ppFVC from baseline(At Week 52)
- Proportion of participants with absolute decline in ppFVC ≥10%(At 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)(At Week 52)
- Number of participants with Adverse Events (AEs)(Up to 28 days after last dose)
- Number of participants with AEs related to IMP(Up to 28 days after last dose)
- Number of participants with Serious AEs (SAEs)(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)
- Number of participants with vital sign abnormalities(Up to 28 days after last dose)
研究者
研究点 (835)
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