NCT07600021尚未招募2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SYH2059 Tablets in Adult Patients With Idiopathic Pulmonary Fibrosis.
InnovStone Therapeutics Limited0 个研究点目标入组 156 人开始时间: 2026年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 主要终点
- Change in FVC from baseline (mL)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It Aims aims to evaluate the efficacy and safety of different doses of SYH2059 tablets compared with placebo in adult patients with IPF, observe the PK profile of SYH2059 tablets in adult IPF patients, and assess the population pharmacokinetic (PPK) profile, exposure-response (E-R) relationship, as well as the changing trends of blood biomarkers.
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
- •1. Age ≥ 40 years, regardless of gender;
- •2. The investigator confirms the clinical diagnosis of IPF in participants based on chest HRCT, surgical lung biopsy, or transbronchial lung cryobiopsy (if available) performed during the screening period or within 1 year prior to screening (see Appendix 13.7 for details);
- •3. FVCpp ≥ 45% during the screening period;
- •4. Hemoglobin-corrected DLCOpp ≥ 25% and < 90% during the screening period;
- •5. Received a single stable-dose antifibrotic therapy for at least 12 weeks prior to screening (concurrent use of nintedanib and pirfenidone is prohibited) and will continue after randomization; or had not received stable antifibrotic therapy, or had discontinued such therapy for at least 8 weeks, with no plan to initiate antifibrotic therapy during the trial;
- •6. Understands the purpose and risks of this study, comprehends and agrees to comply with all study procedures, consents to participate, and provides written informed consent.
排除标准
- •1. Interstitial lung disease other than IPF.
- •2. Airway obstruction during screening (FEV₁/FVC < 0.7), or emphysema greater than pulmonary fibrosis on HRCT.
- •3. Confirmed or suspected acute exacerbation of IPF within 3 months prior to screening.
- •4. Investigator judgment that IPF severity showed sustained improvement during the 12 months prior to screening, based on changes in FVC, DLCO and/or HRCT findings.
- •5. Other clinically significant respiratory diseases during screening.
- •6. Severe diseases in any other system (cardiovascular, digestive, neurological, hematological, endocrine) during screening.
- •7. Malignancy within 5 years prior to screening (excluding treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin, or carcinoma in situ of the cervix).
- •8. Any acute infection within 2 weeks prior to screening that has not fully recovered per investigator judgment.
- •9. Active, unstable or uncontrolled vasculitis within 8 weeks prior to screening.
- •10. Any acute or chronic active infection during screening.
- •11. C-SSRS assessment during screening indicating suicidal behavior within the past 2 years (actual attempt, interrupted attempt, aborted attempt, or preparatory acts or gestures), or clinically significant suicidal ideation within 3 months prior to screening or during screening (participant answered "yes" to C-SSRS suicidal ideation question 4 or 5).
- •12. Treatment with PDE1, PDE3, PDE4, PDE10 inhibitors, or non-selective PDE inhibitors within 4 weeks prior to screening.
- •13. Use of strong CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of investigational product, or inability to discontinue such agents during the study.
- •14. Receiving immunomodulatory agents (excluding oral glucocorticoids) for respiratory or pulmonary conditions during screening, or prednisone (or equivalent) at a daily dose > 15 mg.
- •15. Abnormal hepatic and renal function during screening: ALT, AST > 2.5 × ULN, or TBIL > 1.5 × ULN, or eGFR < 30 mL/min/1.73 m².
- •16. Severe, persistent, uncontrolled hypertension during screening (SBP ≥ 180 mmHg or DBP ≥ 100 mmHg).
- •17. History of smoking within 3 months prior to screening or unwillingness to abstain from smoking (including e-cigarettes) during the study.
- •18. Hypersensitivity to SYH2059 or any excipients, or history of severe drug allergy.
- •19. Participation in any clinical trial within 4 weeks prior to screening (excluding those not receiving investigational product).
- •20. Participation in a clinical study of the same target drug and receipt of treatment within 3 months prior to screening.
- •21. Pregnant or lactating females; fertile females or males unwilling to practice strict contraception throughout the trial and for 3 months after trial completion until the end of the safety follow-up period (including male participants).
- •Any other conditions deemed inappropriate for trial participation by the investigator.
- •22. Additional Exclusion Criteria (for PK intensive sampling participants):
- •23. Previous history of gastrointestinal surgery that may interfere with the PK of the investigational product.
- •24. Alcohol consumption exceeding 14 units per week within 4 weeks prior to screening.
- •25. Habitual excessive intake of xanthine- or caffeine-containing foods, beverages, or other substances affecting drug absorption, distribution, metabolism or excretion within 4 weeks prior to screening.
研究组 & 干预措施
High-dose group
Experimental
SYH2059 tablets were administered twice daily at 6mg after meals for 12 weeks.
干预措施: SYH2059 Tablets (Drug)
Medium-dose group
Experimental
SYH2059 tablets were administered twice daily at 3mg after meals for 12 weeks.
干预措施: SYH2059 Tablets (Drug)
Low dose group
Experimental
SYH2059 tablets were administered twice daily at 1.5 mg after meals for 12 weeks.
干预措施: SYH2059 Tablets (Drug)
Placebo group
Placebo Comparator
Placebo tablets were administered twice daily at 1.5 mg after meals for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in FVC from baseline (mL)
时间窗: Week 12
FVC is one of the pulmonary function indicators; FVC values in patients with IPF tend to decrease.
次要结局
- PK parameters after multiple doses in intensively sampled participants: Cmax,ss(Week 1,2)
- PK parameters after multiple doses in intensively sampled participants: Cmin,ss.(Week 1,2)
- PK parameters after multiple doses in intensively sampled participants: AUC0-tau,ss.(Week 1,2)
- PK parameters after multiple doses in intensively sampled participants: Tmax,ss.(Week 1,2)
- Changes in blood biomarkers from baseline.(Week 4,8,12)
- Change in FVC from baseline (mL)(Week 2,4,8)
- PK parameters after the first dose in intensively sampled participants: Tmax.(Day 1)
- PK parameters after multiple doses in intensively sampled participants: Ctau,ss.(Week 1,2)
- Change in FVCpp from baseline(Week 12)
- Proportion of participants with an absolute decrease in FVCpp >10% from baseline(Week 12)
- Proportion of participants with no decrease in FVCpp from baseline(Week 12)
- Adjusted change in DLCOpp from baseline(Week 12)
- Change from baseline in L-PF scale score(Week 12)
- Changes in IPF symptoms (cough, dyspnea, fatigue) assessed by VAS from baseline(Week 12)
- Incidence and severity of adverse events(Week 13)
- Changes in C-SSRS over time during the trial(Week 13)
- Plasma concentrations of sparsely sampled participants pre-dose and 2 hours post-dose on Day 14 and Day 84(Week 2,12)
- PK parameters after the first dose in intensively sampled participants: Cmax.(Day 1)
- PK parameters after the first dose in intensively sampled participants: AUC0-12.(Day 1)
研究者
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