Actively Recruiting
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
Led by Sunshine Lake Pharma Co., Ltd. · Updated on 2026-04-24
110
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to participate and sign the informed consent form.
- Male or female patients aged 18 years or older.
- Patients with known or unknown cause (except IPF) and clear pulmonary fibrosis on chest CT after at least 3 months of conventional treatment.
- Evidence of disease progression within 12 months before screening, including worsening respiratory symptoms, lung function decline (FVC decline ≥ 5% or DLco decline ≥ 10%), or radiological signs of progression.
- Fibrosing lung disease on HRCT with disease extent over 10% confirmed by central readers.
- Patients with connective tissue disease must be stable with no changes in therapy within 12 weeks before randomization.
- FEV1/FVC ratio ≥ 0.7 before bronchodilators.
- Predicted FVC % ≥ 45%.
- Hemoglobin-corrected DLCO between 30% and 80% of predicted.
- Fertile males and females agree to effective contraception from signing consent until 30 days after last dose.
- Willing and able to comply with study requirements and attend visits as assessed by the investigator.
You will not qualify if you...
- Diagnosis of idiopathic pulmonary fibrosis (IPF).
- Presence of other lung abnormalities affecting study results.
- Significant pulmonary arterial hypertension or right heart failure.
- Major extrapulmonary restrictions such as chest wall abnormality or large pleural effusion.
- Expected lung transplantation during the study.
- Expected survival less than 6 months.
- History of malignant tumors within 5 years except certain localized cancers.
- Clinically significant thyroid dysfunction requiring treatment.
- Unstable or worsening heart disease in the last 6 months including angina, heart attack, severe heart failure, or uncontrolled arrhythmias.
- Elevated liver enzymes or poor kidney function (CLcr < 50 mL/min).
- Positive HIV or treponema pallidum antibody.
- Uncontrolled hepatitis B or C infection.
- Recent use of medications that affect lung disease or study drug safety including certain immunosuppressants, corticosteroids, antifibrotics, or biologics within specified timeframes.
- Inability to complete pulmonary function tests, 6-minute walk test, or questionnaires.
- Allergy to any component of HEC585 tablets.
- Participation in another clinical study within 3 months before screening.
- Pregnancy or breastfeeding.
- Smoking ≥ 10 cigarettes per day within 3 months before screening or unwillingness to quit.
- History of alcohol or drug abuse within 6 months before screening.
- Any condition affecting safety, compliance, or study completion as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
H
HuaPing Dai, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here