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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose group | Experimental | SYH2059 tablets were administered twice daily at 6mg after meals for 12 weeks. |
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| Medium-dose group | Experimental | SYH2059 tablets were administered twice daily at 3mg after meals for 12 weeks. |
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| Low dose group | Experimental | SYH2059 tablets were administered twice daily at 1.5 mg after meals for 12 weeks. |
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| Placebo group | Placebo Comparator | Placebo tablets were administered twice daily at 1.5 mg after meals for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYH2059 Tablets | Drug | Take twice daily, about 12 hours apart, after meals, for 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in FVC from baseline (mL) | FVC is one of the pulmonary function indicators; FVC values in patients with IPF tend to decrease. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FVC from baseline (mL) | FVC is one of the pulmonary function indicators; FVC values in patients with IPF tend to decrease. | Week 2,4,8 |
| Change in FVCpp from baseline | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
Any other conditions deemed inappropriate for trial participation by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Eligible participants will be randomly assigned to one of the treatment groups in a 1:1:1:1 ratio.
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| Placebo | Drug | Take twice daily, about 12 hours apart, after meals, for 12 weeks. |
|
| 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 | The L-PF questionnaire is used to assess patients' symptoms. It consists of 21 items covering two main domains: the Symptom Module and the Impact Module. Higher scores indicate more severe symptoms and poorer quality of life. | Week 12 |
| Changes in IPF symptoms (cough, dyspnea, fatigue) assessed by VAS from baseline | The Visual Analogue Scale (VAS) is a commonly used clinical tool for assessing the intensity of subjective symptoms. It typically consists of a 0 - 10 cm line segment, where 0 indicates no symptoms and 10 indicates the most severe symptoms. | Week 12 |
| Incidence and severity of adverse events | Week 13 |
| Changes in C-SSRS over time during the trial | The Columbia Suicide Severity Rating Scale (C-SSRS) is an internationally recognized standardized tool for suicide risk assessment. It systematically evaluates suicidal ideation , suicidal behavior and self-injurious behavior. Suicidal ideation is graded in severity on a 1 -5 scale, with higher scores indicating stronger suicidal ideation. | 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 |
| 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 |
| 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 |