A Phase II Study to Evaluate the Efficacy and Safety of SYH2059 Tablets in Adult Patients With Idiopathic Pulmonary Fibrosis

NCT07600021 | Not Yet Recruiting Phase 2

• 1 other identifier: SYH2059-003
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (19)

• Change in FVC from baseline (mL)

  Week 2,4,8

• 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

Study Arms (4)

High-dose group

EXPERIMENTAL

SYH2059 tablets were administered twice daily at 6mg after meals for 12 weeks.

Drug: SYH2059 Tablets

Medium-dose group

EXPERIMENTAL

SYH2059 tablets were administered twice daily at 3mg after meals for 12 weeks.

Drug: SYH2059 Tablets

Low dose group

EXPERIMENTAL

SYH2059 tablets were administered twice daily at 1.5 mg after meals for 12 weeks.

Drug: SYH2059 Tablets

Placebo group

PLACEBO COMPARATOR

Placebo tablets were administered twice daily at 1.5 mg after meals for 12 weeks.

Drug: Placebo

Interventions

SYH2059 Tablets DRUG

Take twice daily, about 12 hours apart, after meals, for 12 weeks.

High-dose group; Low dose group; Medium-dose group

Placebo DRUG

Take twice daily, about 12 hours apart, after meals, for 12 weeks.

Placebo group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 40 years, regardless of gender;
• \. 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);
• \. FVCpp ≥ 45% during the screening period;
• \. Hemoglobin-corrected DLCOpp ≥ 25% and \< 90% during the screening period;
• \. 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;
• \. 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.

You may not qualify if:

• \. Interstitial lung disease other than IPF.
• \. Airway obstruction during screening (FEV₁/FVC \< 0.7), or emphysema greater than pulmonary fibrosis on HRCT.
• \. Confirmed or suspected acute exacerbation of IPF within 3 months prior to screening.
• \. 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.
• \. Other clinically significant respiratory diseases during screening.
• \. Severe diseases in any other system (cardiovascular, digestive, neurological, hematological, endocrine) during screening.
• \. 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).
• \. Any acute infection within 2 weeks prior to screening that has not fully recovered per investigator judgment.
• \. Active, unstable or uncontrolled vasculitis within 8 weeks prior to screening.
• \. Any acute or chronic active infection during screening.
• \. 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).
• \. Treatment with PDE1, PDE3, PDE4, PDE10 inhibitors, or non-selective PDE inhibitors within 4 weeks prior to screening.
• \. 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.
• \. Receiving immunomodulatory agents (excluding oral glucocorticoids) for respiratory or pulmonary conditions during screening, or prednisone (or equivalent) at a daily dose \> 15 mg.
• \. 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.

Sponsors & Collaborators

• InnovStone Therapeutics Limited: lead

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible participants will be randomly assigned to one of the treatment groups in a 1:1:1:1 ratio.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share