RecruitingPhase 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 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


Sponsor

Sunshine Lake Pharma Co., Ltd.

Enrollment

110 participants

Start Date

Feb 15, 2023

Study Type

INTERVENTIONAL

Conditions

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. main study stage with 24 weeks treatment duration followed by up to 96 weeks treatment extended study stage.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an investigational drug called HEC585 to see whether it can slow the worsening of lung function in patients with progressive fibrosing interstitial lung disease (PF-ILD) — a group of conditions where lung tissue becomes progressively scarred, making breathing increasingly difficult over time. You may be eligible if: - You are 18 years of age or older - You have progressive pulmonary fibrosis (not IPF) confirmed on CT scan - Your lung function has measurably declined in the past 12 months - Your FVC is at least 45% of predicted and your DLCO is between 30% and 80% of predicted - You have been on standard treatment for at least 3 months You may NOT be eligible if: - You have idiopathic pulmonary fibrosis (IPF) — the most common form - You have significant pulmonary arterial hypertension with right heart failure - You are expected to need a lung transplant during the study - Your expected survival is less than 6 months - You have had cancer within the past 5 years - You have significant heart disease, severe liver or kidney impairment, or HIV/hepatitis - You are a heavy smoker (10 or more cigarettes per day in the past 3 months) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHEC585 dose A

taking HEC585 dose A orally once daily, up to 24 weeks in main stage (if applicable); up to 96 weeks in extended stage

DRUGHEC585 dose B

taking HEC585 dose B orally once daily, up to 24 weeks in main stage; up to 96 weeks in extended stage

DRUGPlacebo

taking Placebo orally once daily, up to 24 weeks in main stage


Locations(1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

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NCT05139719