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New treatment option for Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive...
Official title 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
ClinicalTrials.gov ID: NCT05139719
What this study is testing
What is HEC585 dose A?
HEC585 dose A is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for progressive fibrosing interstitial lung disease (pf-ild) / progressive pulmonary fibrosis (ppf).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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):
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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):
- 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...
- 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 people agreed and promised to take effective contraception measures from signing the ICF till 30 days after last administration.
- people are willing and able to comply with the protocol requirements and attend visits assessed by the investigator.
- 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...
- 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.
- 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...
- 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.