A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF)
试验速览
- 阶段
- 不适用
- 状态
- Other (Terminated)
- 发起方
- 入组人数
- 1,113
- 试验地点
- 15
- 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) at Week 52
研究概览
简要总结
This is a randomized, double-blind, dose-ranging, placebo-controlled, operationally seamless Phase 2b/3 study to select a bexotegrast dose from two dose levels and evaluate the efficacy and safety of 2 doses of bexotegrast (ie, 160 and 320 mg) taken for 52 weeks by participants with IPF taking and not taking background therapy (ie, nintedanib or pirfenidone). Participants will be randomized in 3 groups with a separate data analysis for Group 1 (Phase 2b dose selection) and a separate data analysis for Groups 2 and 3 (Phase 3 dose confirmation) with no data sharing between analyses. The key purposes of each group are: Group 1 (Phase 2b): • Dose selection (160 or 320 mg) for further study by characterizing efficacy and safety of bexotegrast Group 2 (Phase 3): • To allow a seamless transition from Group 1 to Group 3 by continuing enrollment and data collection in the study during Group 1 treatment period and data analysis (operationally seamless component) • Enrollment in Group 2 will be country specific depending on health authority approval Group 3 (Phase 3): • Establish the efficacy and safety of bexotegrast at the selected dose. The final analysis set will include: o Group 2 participants ▪ Randomized to placebo ▪ Randomized to the selected dose o All Group 3 participants 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Greater than or equal to 40 years of age prior to screening 2.IPF diagnosis less than or equal to 7 years prior to screening 3.FVCpp greater than or equal to 45 percentage 4.Diffusing capacity for carbon monoxide percent predicted hemoglobin-adjusted greater than or equal to 30 percentage and less than 90 percentage 5.Current treatment for IPF with background therapy is allowed, if at a stable dose for greater than or equal to 12 weeks prior to screening 6.If not currently receiving treatment for IPF either treatment naïve or discontinued prior treatment, participant must not have taken background therapy for within 8 weeks prior to screening.
排除标准
- •1.Receiving pharmacologic therapy for pulmonary hypertension 2.Self-reported smoking of any kind not limited to tobacco less than or equal to 12 weeks prior to the screening or unwilling to avoid smoking throughout the study 3.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 4.Hepatic impairment or end-stage liver disease 5.Renal impairment or end stage kidney disease requiring dialysis 6.Pregnant or lactating female participant 7.Uncontrolled systemic arterial hypertension 8.Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF 9.Prior administration of bexotegrast
- •Likely to have lung transplantation during the study being on transplantation list is not an exclusion 11.Forced expiratory volume in the first second/FVC ratio less than 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.
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) at Week 52
时间窗: Endpoints: Change from baseline in absolute FVC (mL) at Week 52
次要结局
- 1. To characterize the effect of bexotegrast versus placebo over 52 weeks of treatment on disease progression(2. To characterize the effect of bexotegrast versus placebo on the change in FVC in participants with & without background therapy at baseline with IPF at Week 52.)