NCT07284459招募中2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 324
- 试验地点
- 70
- 主要终点
- Absolute change in forced vital capacity (FVC) (mL)
研究概览
简要总结
This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.
详细描述
This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and PK of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis with or without background treatment. The treatment period is 26 weeks and full study duration is up to 36 weeks including Screening and Follow-Up. Approximately 324 participants will be enrolled into one of three treatment arms, PIPE-791 Dose A, PIPE-791 Dose B, or placebo.
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
- •Male or female ≥ 40 years of age at the time of Randomization.
- •A diagnosis of IPF within 7 years prior to Screening, based on the 2022 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT consistent with usual interstitial pneumonia (UIP) or probable UIP.
- •Percent predicted (pp) FVC ≥ 40% on Screening spirometry.
- •Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy approved for the treatment of IPF, but not both concurrently.
排除标准
- •Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.
- •Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible.
- •Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible.
- •Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible.
- •Female participants must not be of childbearing potential.
- •Additional inclusion and exclusion criteria apply.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
PIPE-791 Dose B
Experimental
干预措施: PIPE-791 Dose B (Drug)
PIPE-791 Dose A
Experimental
干预措施: PIPE-791 Dose A (Drug)
结局指标
主要结局
Absolute change in forced vital capacity (FVC) (mL)
时间窗: From baseline to Week 26
次要结局
- To investigate the safety and tolerability of PIPE-791 compared to placebo based on percentage of treatment-emergent adverse events (TEAE)(From baseline to Week 30)
- Relative change in FVC (mL)(From baseline to Week 26)
- Time to first ≥10% absolute decline in ppFVC(From baseline to time of first ≥10% absolute decline, up to Week 26)
- Proportion of subjects with a ≥10% absolute decline in percent predicted FVC (ppFVC)(From baseline to Weeks 12 and Week 26)
- Absolute change in ppFVC(From baseline to Week 26)
- Relative change in ppFVC(From baseline to Week 26)
- To investigate the safety and tolerability of PIPE-791 compared to placebo based on percentage of treatment-emergent adverse events (TEAE)(From baseline to Week 30)
- Relative change in FVC (mL)(From baseline to Week 26)
- Time to first ≥10% absolute decline in ppFVC(From baseline to time of first ≥10% absolute decline, up to Week 26)
- Proportion of participants with a ≥10% absolute decline in percent predicted FVC (ppFVC)(From baseline to Weeks 12 and Week 26)
- Change in quantitative CT-derived lung fibrosis burden on HRCT(From baseline to Week 26)
研究者
研究点 (70)
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相关资讯
Contineum's JNJ-5120/PIPE-307 Misses Primary Endpoint in Phase 2 MOONLIGHT-1 Depression Trial- The Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 did not meet its primary efficacy endpoint in adults with major depressive disorder, Contineum Therapeutics reported.
- The trial assessed improvement from baseline in MADRS total score at Day 5 versus placebo; the M1 receptor inhibitor was well-tolerated with no new safety signals.
- Johnson & Johnson, which develops the drug under a global license agreement, is analyzing prespecified exploratory endpoints to assess clinical relevance and next steps.
- Contineum separately affirmed its Phase 2 PROPEL-IPF trial of PIPE-791, now with more than 55 sites across eight countries, and a cash runway through mid-2029.last monthContineum Therapeutics Advances PIPE-791 Phase 2 Trial for Idiopathic Pulmonary Fibrosis with Differentiated LPA1 Receptor Targeting- Contineum Therapeutics has initiated patient dosing in PROPEL-IPF, a global Phase 2 trial evaluating PIPE-791 for idiopathic pulmonary fibrosis, targeting 324 patients over 26 weeks with a primary endpoint of forced vital capacity change.
- PIPE-791 demonstrates potential differentiation from Bristol Myers Squibb's competing LPA1 antagonist through achieving approximately 90% receptor occupancy at 1 mg daily dosing and showing no hypotension signal to date.
- The company maintains financial runway through mid-2029 following a $93 million public offering, while also advancing PIPE-307 in partnership with Johnson & Johnson for major depressive disorder treatment.
- Topline data from an exploratory PIPE-791 Phase 1b chronic pain trial is expected in Q2 2026, potentially supporting quality-of-life benefits in pulmonary fibrosis populations.6 months ago