A Phase II Study to Evaluate the Efficacy and Safety of SYH2059 Tablets in Adult Patients With Id… (NCT07600021) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Study to Evaluate the Efficacy and Safety of SYH2059 Tablets in Adult Patients With Idiopathic Pulmonary Fibrosis
156 participantsStarted 2026-06-30
Plain-language summary
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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 respira…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.