Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)Phase 2NCT05139719
A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients
A Phase 2 study testing HEC585 dose A and HEC585 dose B in people with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF), run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
The main goal of this phase llb study is to compare the efficacy and safety of two doses of HEC585 tablets with placebo which is a look-alike substance that contains no active drug in patients with progressive fibrosing interstitial lung diseases. This study is divided into two stages, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)
- What is being tested?
- HEC585 dose A and HEC585 dose B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2023to Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to participate and sign the ICF.
- Male or female patients' age ≥ 18 years when signing the ICF.
- Patients with known or unknown etiology (except IPF) and clear pulmonary fibrosis on chest CT have undergone conventional clinical treatment (assessed by the investigator, including follow-up observation) for ≥ 3 months. At least two of the following criteria occurring within 12 months before screening without alternative explanation (such as infection, heart failure, etc.):
- Worsening respiratory symptoms like cough, shortness of breath. ii) Physiological evidence of disease progression (either of the following):
- absolute FVC (% of predicted) decline ≥ 5%.
- absolute DLco[Hb corrected] (% of predicted) decline ≥ 10%. iii) Radiological evidence of disease progression (one or more of the following):
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- Increased extent or severity of traction bronchiectasis and bronchiolectasis.
- New ground-glass opacity with traction bronchiectasis.
- New fine reticulation.
- Increased extent or increased coarseness of reticular abnormality.
- New or increased honeycombing.
- Increased lobar volume loss.
- Fibrosing lung disease on HRCT, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of >10% as confirmed by central readers.
- For patients with underlying connective tissue disease (CTD) should be in the stable status which is defined by no initiation of new therapy, treatment dose adjustment or withdrawal of therapy within 12 weeks prior to randomization.
- FEV1/FVC ≥ 0.7 before using bronchodilators.
- %FVC ≥ 45% predicted.
- Carbon Monoxide Diffusion Capacity (DLCO) corrected for Haemoglobin (Hb) ≥ 30% and ≤ 80% predicted of normal.
- Fertile female or male subjects agreed and promised to take effective contraception measures from signing the ICF till 30 days after last administration.
- Subjects are willing and able to comply with the protocol requirements and attend visits assessed by the investigator.
Who cannot join
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF).
- Lung with other clinically significant abnormalities which the investigator assess to have an effect on the results of study.
- Significant Pulmonary Arterial Hypertension (PAH), such as meeting the following: Previous clinical or echocardiographic evidence of significant right heart failure, History of right heart catheterization showing a cardiac index ≤ 2 L/min/m², or PAH requiring parenteral therapy with epoprostenol/treprostinil.
- Major extrapulmonary physiological or pathological restriction (e.g. chest wall abnormality, large pleural effusion).
- Expected to receive lung transplantation during the study.
- Expected survival time is less than 6 months.
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- History of malignant tumors within 5 years (except for localized cancers such as basal cell carcinoma and carcinoma in situ of cervix).
- Thyroid dysfunction that the investigator assessed to be clinically significant and needed to be treated.
- History of unstable or worsening heart disease during the 6 months prior to screening, including but not limited to the following:
- Unstable cardiac angina,
- Acute Myocardial infarction,
- Congestive heart failure (need to be treated in hospital or NYHA III/IV),
- Uncontrolled Severe Arrhythmias.
- TBIL >1.2 × ULN, AST or ALT > 1.5 × ULN.
- CLcr < 50 mL/min.
- Human immunodeficiency virus (HIV) or treponema pallidum antibody is positive.
- Uncontrolled hepatitis B virus infection or hepatitis C virus infection.
- Use of any of the following medications for the treatment of Interstitial Lung Disease (ILD) or influence the effect or safety of investigational drug:
- Strong inducers or strong inhibitors of CYP3A4 within 4 weeks before randomization.
- Azathioprine (AZA), cyclosporine, MMF ( > 1.5 g/d or equivalent dose), tripterygium glycosides , hydroxychloroquine, tacrolimus, prednisone > 15mg/day or equivalent systemic glucocorticoid therapy, and the combination of OCS+AZA+NAC within 4 weeks before randomization.
- Cyclophosphamide within 8 weeks before randomization.
- Combination of ≤ 15mg/day or equivalent systemic glucocorticoid therapy with ≤ 1.5 g/d or equivalent dose MMF within 12 weeks before randomization.
- Pirfenidone or nintedanib within 1 months before screening.
- Rituximab, Adalimumab, Secukinumab, Infliximab, Tocilizumab, Certolizumab, Golimumab, Tofacitinib, Baricitinib, Etanercept, Abatacept within 6 months before randomization.
- Subjects cannot complete the PFT、6MWT,or questionnaires.
- Allergic to any component of HEC585 Tablets.
- Participated in other clinical study and received the last dose within 3 months before screening.
- Pregnant or breastfeeding.
- History of smoking (≥ 10 cigarettes/day) within 3 months before screening or are unwilling to quit smoking during the study.
- History of alcohol or drug abuse within 6 months before the screening.
- Any condition that, in the opinion of the investigator, would compromise the safety or compliance of the subject, or prevent the subject from completing the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
About this study
Official title: A Phase IIb, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HEC585 Tablets in Patients With Progressive Fibrosing Interstitial Lung Disease
The main goal of this phase llb study is to compare the efficacy and safety of two doses of HEC585 tablets with placebo which is a look-alike substance that contains no active drug in patients with progressive fibrosing interstitial lung diseases. This study is divided into two stages, i.e. main study stage with 24 weeks treatment duration followed by up to 96 weeks treatment extended study stage.
- Conditions
- Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)
- Being tested
- HEC585 dose A, HEC585 dose B, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC585 dose ADrug
taking HEC585 dose A orally once daily, up to 24 weeks in main stage (if applicable); up to 96 weeks in extended stage
HEC585 dose BDrug
taking HEC585 dose B orally once daily, up to 24 weeks in main stage; up to 96 weeks in extended stage
PlaceboDrug
taking Placebo orally once daily, up to 24 weeks in main stage
| Study group | Role | What they receive |
|---|---|---|
| HEC585 tables does A | Experimental | Not described Receives: Drug: HEC585 dose A |
| HEC585 tables does B | Experimental | Not described Receives: Drug: HEC585 dose B |
| placebo | Placebo comparator | Placebo once daily up to 24 weeks in main stage; HEC585 dose A once daily up to 96 weeks in extended stage Receives: Drug: HEC585 dose A; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 24 in FVC (mL) compared with placebo
change in FVC (mL), measured using Spirometer, from baseline to week 24
Measured: 24 Weeks
Secondary outcomes (12)
Change from Baseline to Week 12 in FVC (mL) compared with placebo
change in FVC (mL), measured using Spirometer, from baseline to week 12
Measured: 12 Weeks
Proportion of subjects with the decline from baseline in FVC (% predicted) > 10%
The proportion of subjects whose %FVC decline from baseline by more than 10% in each treatment group at week 24
Measured: 24 Weeks
Proportion of subjects with the decline from baseline in FVC (% predicted) > 5%
The proportion of subjects whose %FVC decline from baseline by more than 5% in each treatment group at week 24
Measured: 24 Weeks
Changes of DLco (Hb correction)
Measured: 12 Weeks, 24 Weeks
Changes of 6MWT results
Measured: 12 Weeks, 24 Weeks
Changes of St George' s Respiratory Questionnaire (SGRQ)
The higher the score, the more serious the impact on life
Measured: 12 Weeks, 24 Weeks
Changes of The University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ)
Scores range from 0 to 120. The higher the score, the more severe the difficulty in breathing
Measured: 12 Weeks, 24 Weeks
Changes of Leicester coughing questionnaire scores
Scores range from 3 to 21. The lower the score, the greater the impact of cough on quality of life
Measured: 12 Weeks, 24 Weeks
Changes of HRCT
Measured: 24 Weeks
Time to first acute ILD exacerbation or death
the time duration from randomization to first acute ILD exacerbation or death whichever occurs first
Measured: 24 Weeks
Proportion of subjects with death caused by any reason(s)
Measured: 24 Weeks
Proportion of subjects with death caused by the respiratory reason
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start15 Feb 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)Studies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139719
- Sponsor's protocol ID
- HEC585-PF-202
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HEC585 Tablets in Patients With Progressive Fibrosing Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT05139719
- Acronym / sponsor ID
- HEC585-PF-202
- Conditions
- Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Dec 2021 (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.
The main goal of this phase llb study is to compare the efficacy and safety of two doses of HEC585 tablets with placebo which is a look-alike substance that contains no active drug in patients with progressive fibrosing interstitial lung diseases. This study is divided into two stages, i.e. main study stage with 24 weeks treatment duration followed by up to 96 weeks treatment extended study stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HEC585 tables does A | Experimental | Drug: HEC585 dose A |
| HEC585 tables does B | Experimental | Drug: HEC585 dose B |
| placebo | Placebo comparator | Drug: HEC585 dose A, Drug: PlaceboPlacebo once daily up to 24 weeks in main stage; HEC585 dose A once daily up to 96 weeks in extended stage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Volunteer to participate and sign the ICF.
- Male or female patients' age ≥ 18 years when signing the ICF.
- Patients with known or unknown etiology (except IPF) and clear pulmonary fibrosis on chest CT have undergone conventional clinical treatment (assessed by the investigator, including follow-up observation) for ≥ 3 months. At least two of the following criteria occurring within 12 months before screening without alternative explanation (such as infection, heart failure, etc.):
- <!-- -->
- Fibrosing lung disease on HRCT, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of >10% as confirmed by central readers.
Key exclusion criteria (31 listed)
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF).
- Lung with other clinically significant abnormalities which the investigator assess to have an effect on the results of study.
- Significant Pulmonary Arterial Hypertension (PAH), such as meeting the following: Previous clinical or echocardiographic evidence of significant right heart failure, History of right heart catheterization showing a cardiac index ≤ 2 L/min/m², or PAH requiring parenteral therapy with epoprostenol/treprostinil.
- Major extrapulmonary physiological or pathological restriction (e.g. chest wall abnormality, large pleural effusion).
- Expected to receive lung transplantation during the study.
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 |
|---|---|---|
| HEC585 dose Ataking HEC585 dose A orally once daily, up to 24 weeks in main stage (if applicable); up to 96 weeks in extended stage | Drug | HEC585 tables does A, placebo |
| HEC585 dose Btaking HEC585 dose B orally once daily, up to 24 weeks in main stage; up to 96 weeks in extended stage | Drug | HEC585 tables does B |
| Placebotaking Placebo orally once daily, up to 24 weeks in main stage | Drug | placebo |
Primary outcome
Change from Baseline to Week 24 in FVC (mL) compared with placebo
Time frame: 24 Weeks
change in FVC (mL), measured using Spirometer, from baseline to week 24
12 secondary outcomes
Change from Baseline to Week 12 in FVC (mL) compared with placebo
Time frame: 12 Weeks
Proportion of subjects with the decline from baseline in FVC (% predicted) > 10%
Time frame: 24 Weeks
Proportion of subjects with the decline from baseline in FVC (% predicted) > 5%
Time frame: 24 Weeks
Changes of DLco (Hb correction)
Time frame: 12 Weeks, 24 Weeks
Changes of 6MWT results
Time frame: 12 Weeks, 24 Weeks
Changes of St George' s Respiratory Questionnaire (SGRQ)
Time frame: 12 Weeks, 24 Weeks
Changes of The University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ)
Time frame: 12 Weeks, 24 Weeks
Changes of Leicester coughing questionnaire scores
Time frame: 12 Weeks, 24 Weeks
Changes of HRCT
Time frame: 24 Weeks
Time to first acute ILD exacerbation or death
Time frame: 24 Weeks
Proportion of subjects with death caused by any reason(s)
Time frame: 24 Weeks
Proportion of subjects with death caused by the respiratory reason
Time frame: 24 Weeks
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 24 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HEC585 dose A and HEC585 dose B in people with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF), run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
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 20 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 HuaPing Dai, Ph.D (010-84206271, daihuaping@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 24 in FVC (mL) compared with placebo (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026.