Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-11-30; most recent amendment 2026-04-21.
Status change: Not Yet Recruiting → Recruiting 2023-07-02
Trial Details
NCT Number NCT05139719
Lead Sponsor Sunshine Lake Pharma Co., Ltd.
Conditions Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)
Enrollment 110 participants
Start Date 2023-02-15
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-24