Idiopathic Pulmonary FibrosisPhase 2NCT07600021

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

A Phase 2 study testing SYH2059 Tablets in people with Idiopathic Pulmonary Fibrosis, run by InnovStone Therapeutics Limited.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Idiopathic Pulmonary Fibrosis
What is being tested?: SYH2059 Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 156 participants
Where: No sites listed yet
Study dates: 30 Jun 2026to 30 Dec 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

About this study

Official title: 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.

Conditions: Idiopathic Pulmonary Fibrosis
Being tested: SYH2059 Tablets, Placebo
Medical subject headings: Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SYH2059 TabletsDrug
Take twice daily, about 12 hours apart, after meals, for 12 weeks.
PlaceboDrug
Take twice daily, about 12 hours apart, after meals, for 12 weeks.

Study groups in NCT07600021
Study group	Role	What they receive
High-dose group	Experimental	SYH2059 tablets were administered twice daily at 6mg after meals for 12 weeks. Receives: Drug: SYH2059 Tablets
Medium-dose group	Experimental	SYH2059 tablets were administered twice daily at 3mg after meals for 12 weeks. Receives: Drug: SYH2059 Tablets
Low dose group	Experimental	SYH2059 tablets were administered twice daily at 1.5 mg after meals for 12 weeks. Receives: Drug: SYH2059 Tablets
Placebo group	Placebo comparator	Placebo tablets were administered twice daily at 1.5 mg after meals for 12 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in FVC from baseline (mL)
FVC is one of the pulmonary function indicators; FVC values in patients with IPF tend to decrease.
Measured: Week 12

Secondary outcomes (19)

Change in FVC from baseline (mL)
FVC is one of the pulmonary function indicators; FVC values in patients with IPF tend to decrease.
Measured: Week 2,4,8
Change in FVCpp from baseline
Measured: Week 12
Proportion of participants with an absolute decrease in FVCpp >10% from baseline
Measured: Week 12
Proportion of participants with no decrease in FVCpp from baseline
Measured: Week 12
Adjusted change in DLCOpp from baseline
Measured: 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.
Measured: 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.
Measured: Week 12
Incidence and severity of adverse events
Measured: 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.
Measured: Week 13
Plasma concentrations of sparsely sampled participants pre-dose and 2 hours post-dose on Day 14 and Day 84
Measured: Week 2,12
PK parameters after the first dose in intensively sampled participants: Cmax.
Measured: Day 1
PK parameters after the first dose in intensively sampled participants: AUC0-12.
Measured: Day 1
PK parameters after the first dose in intensively sampled participants: Tmax.
Measured: Day 1
PK parameters after multiple doses in intensively sampled participants: Ctau,ss.
Measured: Week 1,2
PK parameters after multiple doses in intensively sampled participants: Cmax,ss
Measured: Week 1,2
PK parameters after multiple doses in intensively sampled participants: Cmin,ss.
Measured: Week 1,2
PK parameters after multiple doses in intensively sampled participants: AUC0-tau,ss.
Measured: Week 1,2
PK parameters after multiple doses in intensively sampled participants: Tmax,ss.
Measured: Week 1,2
Changes in blood biomarkers from baseline.
Measured: Week 4,8,12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202630 Dec 2027

First posted20 May 2026
Study start30 Jun 2026 (estimated)
Primary completion30 Oct 2027 (estimated)
Study completion30 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Eligible participants will be randomly assigned to one of the treatment groups in a 1:1:1:1 ratio.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 156 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07600021
Sponsor's protocol ID: SYH2059-003
Status last verified: May 2026
First submitted: 7 May 2026
Last updated: 20 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Clinical Trials Information Group officer

86-0311-69085587

ctr-contact@cspc.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
RecruitingPhase 3
Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Doses of Inhaled CHF10073 in Participants With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis

All Idiopathic Pulmonary Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT07600021
Acronym / sponsor ID: SYH2059-003
Conditions: Idiopathic Pulmonary Fibrosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 156 participants (estimated)
Lead sponsor: InnovStone Therapeutics LimitedIndustry (pharma, biotech, devices)
Study start: 30 Jun 2026 (estimated)
Primary completion: 30 Oct 2027 (estimated)
Study completion: 30 Dec 2027 (estimated)
First posted: 20 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Eligible participants will be randomly assigned to one of the treatment groups in a 1:1:1:1 ratio.

Arm	Type	Receives
High-dose group	Experimental	Drug: SYH2059 TabletsSYH2059 tablets were administered twice daily at 6mg after meals for 12 weeks.
Medium-dose group	Experimental	Drug: SYH2059 TabletsSYH2059 tablets were administered twice daily at 3mg after meals for 12 weeks.
Low dose group	Experimental	Drug: SYH2059 TabletsSYH2059 tablets were administered twice daily at 1.5 mg after meals for 12 weeks.
Placebo group	Placebo comparator	Drug: PlaceboPlacebo tablets were administered twice daily at 1.5 mg after meals for 12 weeks.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (26 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SYH2059 TabletsTake twice daily, about 12 hours apart, after meals, for 12 weeks.	Drug	High-dose group, Low dose group, Medium-dose group
PlaceboTake twice daily, about 12 hours apart, after meals, for 12 weeks.	Drug	Placebo group

Primary outcome

Change in FVC from baseline (mL)
Time frame: Week 12
FVC is one of the pulmonary function indicators; FVC values in patients with IPF tend to decrease.

19 secondary outcomes

Change in FVC from baseline (mL)
Time frame: Week 2,4,8
Change in FVCpp from baseline
Time frame: Week 12
Proportion of participants with an absolute decrease in FVCpp >10% from baseline
Time frame: Week 12
Proportion of participants with no decrease in FVCpp from baseline
Time frame: Week 12
Adjusted change in DLCOpp from baseline
Time frame: Week 12
Change from baseline in L-PF scale score
Time frame: Week 12
Changes in IPF symptoms (cough, dyspnea, fatigue) assessed by VAS from baseline
Time frame: Week 12
Incidence and severity of adverse events
Time frame: Week 13
Changes in C-SSRS over time during the trial
Time frame: Week 13
Plasma concentrations of sparsely sampled participants pre-dose and 2 hours post-dose on Day 14 and Day 84
Time frame: Week 2,12
PK parameters after the first dose in intensively sampled participants: Cmax.
Time frame: Day 1
PK parameters after the first dose in intensively sampled participants: AUC0-12.
Time frame: Day 1
PK parameters after the first dose in intensively sampled participants: Tmax.
Time frame: Day 1
PK parameters after multiple doses in intensively sampled participants: Ctau,ss.
Time frame: Week 1,2
PK parameters after multiple doses in intensively sampled participants: Cmax,ss
Time frame: Week 1,2
PK parameters after multiple doses in intensively sampled participants: Cmin,ss.
Time frame: Week 1,2
PK parameters after multiple doses in intensively sampled participants: AUC0-tau,ss.
Time frame: Week 1,2
PK parameters after multiple doses in intensively sampled participants: Tmax,ss.
Time frame: Week 1,2
Changes in blood biomarkers from baseline.
Time frame: Week 4,8,12

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
Individual participant dataSharing planned: No

Related trials for Idiopathic Pulmonary Fibrosis

RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
RecruitingPhase 3
Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)
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Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Doses of Inhaled CHF10073 in Participants With Idiopathic Pulmonary Fibrosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SYH2059 Tablets in people with Idiopathic Pulmonary Fibrosis, run by InnovStone Therapeutics Limited.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in FVC from baseline (mL) (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07600021.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.