A Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy and Safety of Bexotegrast (PLN-74809) for the Treatment of Idiopathic Pulmonary Fibrosis (BEACON-IPF)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 320
- 试验地点
- 532
- 主要终点
- To characterize the effect of bexotegrast versus placebo on the change in forced vital capacity (FVC) in participants with idiopathic pulmonary fibrosis (IPF)
研究概览
简要总结
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF).
详细描述
This is a randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of 2 doses of bexotegrast (PLN-74809) [160 and 320 mg] taken for 52 weeks by participants with IPF taking and not taking background therapy (ie, nintedanib or pirfenidone).
The study will consist of an up to 35-day Screening Period, a 52-week Treatment Period, and a 14 day Safety Follow-up Period. Of note, participants who are not taking background therapy at study entry will be allowed to initiate it at any time during the study.
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
- •≥ 40 years of age prior to screening
- •IPF diagnosis ≤ 7 years prior to screening
- •FVCpp ≥ 45%
- •Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and < 90%
- •Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening
- •If not currently receiving treatment for IPF (either treatment naïve or discontinued prior treatment), participant must not have taken background therapy for at least 8 weeks prior to screening
排除标准
- •Receiving pharmacologic therapy for pulmonary hypertension
- •Self-reported smoking of any kind (not limited to tobacco)
- •History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated cervical carcinoma in situ
- •Hepatic impairment or end-stage liver disease
- •Renal impairment or end-stage kidney disease requiring dialysis
- •Pregnant or lactating female participant
- •Uncontrolled systemic arterial hypertension
- •Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF
- •Prior administration of bexotegrast
- •Likely to have lung transplantation during the study (being on transplantation list is not an exclusion)
- •Forced expiratory volume in the first second (FEV1)/FVC ratio <0.7 at screening
- •Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization
- •Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening
研究组 & 干预措施
Bexotegrast (PLN-74809) 320 mg Dose
Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks
干预措施: PLN-74809 (Drug)
Bexotegrast (PLN-74809) 160 mg Dose
Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks
干预措施: PLN-74809 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To characterize the effect of bexotegrast versus placebo on the change in forced vital capacity (FVC) in participants with idiopathic pulmonary fibrosis (IPF)
时间窗: 52 weeks
Change from baseline in absolute FVC (mL) at Week 52
Change From Baseline in Forced Vital Capacity at Week 52
时间窗: Baseline (Day 1) and Week 52
The FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer. Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
次要结局
- To characterize the effect of bexotegrast versus placebo over 52 weeks of treatment on disease progression(Up to 52 weeks)
- Time to disease progression defined as(Up to 52 weeks)
- Proportion of participants with disease progression defined as(Up to 52 weeks)
- To characterize the effect of bexotegrast versus placebo on the change in FVC in participants with and without background therapy at baseline with IPF(52 weeks)
- Change from baseline in Living with Pulmonary Fibrosis (L-PF) Dyspnoea and Cough Domain score(52 Weeks)
- Change from baseline in King's Brief Interstitial Lung Disease (K-BILD) questionnaire Total score(52 Weeks)
- To characterize the effect of bexotegrast versus placebo on change in lung fibrosis by high-resolution computed tomography(52 Weeks)
- To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF(Up to 52 weeks)
- To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment(Over 52 Weeks)
- Change From Baseline in Forced Vital Capacity in Participants on and Not on Background Therapy at Week 52(Baseline (Day 1) and Week 52)
- Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Dyspnea and Cough Domain Scores at Week 52(Baseline (Day 1) and Week 52)
- Number of Participants With an Event of Disease Progression(Baseline (Day 1) and up to Week 52)
- Change From Baseline in Quantitative Lung Fibrosis (QLF) Extent at Week 52(Baseline (Day 1) and Week 52)
- Percentage of Participants With a ≥10% Absolute Decline in Forced Vital Capacity Percent Predicted From Baseline or All-cause Mortality Through Week 52(Baseline (Day 1) and up to Week 52)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)(From first dose of study drug (Day 1) up to 14 days post last dose of study drug, up to 378 days)
- Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score at Week 52(Baseline (Day 1) and Week 52)
- Number of Participants With Disease Progression for Hazard Ratio(Baseline (Day 1) and up to Week 52)