NCT07519070尚未招募3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 420
- 主要终点
- Change in FVC from baseline at Week 52
研究概览
简要总结
This study aims to evaluate the efficacy and safety of HSK44459 tablets in patients with idiopathic pulmonary fibrosis (IPF).
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
- •Age ≥40 years, regardless of gender;
- •Diagnosis of IPF confirmed prior to or during screening per the 2022 ATS/ERS/JRS/ALAT guidelines (Appendix 1);
- •Patients must meet one of the following criteria:
- •No treatment with nintedanib or pirfenidone for at least 8 weeks prior to screening (e.g., treatment-naïve or discontinued therapy), with no plans to initiate or resume antifibrotic treatment;
- •On a stable regimen of nintedanib or pirfenidone for at least 12 weeks prior to screening, without combination therapy with both drugs. [Stable therapy is defined as maintaining a constant dosage with tolerable drug-specific adverse events];
- •Percentage predicted forced vital capacity (FVCpp) ≥45% at screening;
- •Percentage predicted diffusing capacity of the lungs for carbon monoxide (DLCOpp) ≥25% and <90% at screening [*hemoglobin (Hb)-adjusted];
- •Willing to participate and voluntarily sign the informed consent form.
排除标准
- •Clinically significant airway obstruction during screening [pre-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) <0.7];
- •Other clinically significant pulmonary abnormalities per investigator judgment (exceptions: conditions requiring no treatment during the trial, e.g., asymptomatic pulmonary nodules, emphysema);
- •Acute IPF exacerbation within 3 months before screening and/or during screening;
- •Receiving immunomodulators (excluding oral corticosteroids) for respiratory conditions, or prednisone >15 mg/day (or equivalent);
- •History of vasculitis;
- •Any suicidal behavior within 2 years before screening (actual attempt, interrupted attempt, aborted attempt, or preparatory acts/behaviors);
- •Type 4 or 5 suicidal ideation per Columbia-Suicide Severity Rating Scale (C-SSRS) within 3 months before/during screening (active suicidal thoughts with method/intent but no plan, or with method/intent/plan);
- •Respiratory infection requiring antibiotics or other infections requiring treatment within 4 weeks before/during screening;
- •Major surgery within 3 months before screening or planned during the study (investigator-assessed; lung transplant listing excluded);
- •Malignancy within 5 years before screening (except treated basal cell carcinoma, squamous cell carcinoma in situ, or cervical carcinoma in situ);
- •Blood pressure ≥160/100 mmHg at screening;
- •Unstable/worsening cardiovascular/cerebrovascular disease within 6 months before screening (e.g., unstable angina, myocardial infarction, heart failure, thromboembolic events including stroke/TIA);
- •Aspartate transaminase (AST) or alanine transaminase (ALT) >2.5×ULN or total bilirubin >1.5×ULN at screening;
- •Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m² at screening;
- •Gastrointestinal surgery/disease affecting pharmacokinetics (PK) (except appendectomy/hernia repair);
- •Active hepatitis B [HBsAg-positive with HBV-DNA above ULN], hepatitis C antibody-positive, syphilis (anti-TP-positive with TRUST above ULN), or HIV infection (anti-HIV-positive) at screening;
- •Current treated liver disease with Child-Pugh A/B/C impairment at screening;
- •Substance abuse, drug use, or excessive alcohol intake (>2 units/day; 1 unit=360 mL beer [5%], 45 mL spirits [40%], or 150 mL wine) within 3 months before screening;
- •Tobacco/nicotine product use within 3 months before screening or unwillingness to abstain during the study;
- •Previous HSK44459 use or PDE1/3/4/10/non-selective PDE inhibitor treatment (excluding HSK44459, e.g., apremilast, roflumilast, ibudilast) within 8 weeks before screening;
- •Use of strong CYP3A4 inhibitors/inducers within 14 days or 5 half-lives (whichever longer) before first dose, or anticipated need during the study;
- •History of severe drug allergy or hypersensitivity to investigational product/excipients;
- •Participation in other clinical trials (receiving investigational drug/placebo) within 1 month before screening;
- •Pregnancy/lactation; participants of childbearing potential unwilling to use contraception during and for 3 months post-study (including male participants);
- •Any other investigator-determined factors making participation unsuitable.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
HSK44459
Experimental
干预措施: HSK44459 (Drug)
结局指标
主要结局
Change in FVC from baseline at Week 52
时间窗: Week 52
次要结局
- Time to first acute IPF exacerbation during the trial(Week 52)
- Time to first respiratory-related hospitalization during the trial(Week 52)
- Time to >5% relative/absolute decline in FVC% predicted from baseline during the trial(Week 52)
- Time to >10% relative/absolute decline in FVC% predicted from baseline during the trial(Week 52)
- Time to >15% absolute decline in DLCO% predicted from baseline during the trial(Week 52)
- Time to first antifibrotic (rescue) therapy use during the trial (non-antifibrotic arm only)(Week 52)
- Time to death during the trial(Week 52)
- Change from baseline in Living with Pulmonary Fibrosis (L-PF) questionnaire total score, impact score, and symptom total score at Week 52(Week 52)
- Change from baseline in L-PF questionnaire symptom domain - dyspnea score at Week 52(Week 52)
- Change from baseline in L-PF questionnaire symptom domain - cough score at Week 52(Week 52)
- Change from baseline in L-PF questionnaire symptom domain - fatigue score at Week 52(Week 52)
- Change from baseline in EQ-5D score at Week 52(Week 52)
- Change from baseline in FVC at Week 26(Week 26)
- Absolute change from baseline in FVC% predicted at Weeks 26 and 52(Weeks 26 and 52)
- Absolute change from baseline in DLCO% predicted at Weeks 26 and 52(Weeks 26 and 52)
- Change from baseline in resting SpO2 (expressed as percentage) at Week 52(Week 52)
- Annualized rate of respiratory-related hospitalizations(Week 52)
研究者
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