NCT05139719

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)

Interventions

Type	Name	Description
DRUG	HEC585 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
DRUG	HEC585 dose B	taking HEC585 dose B orally once daily, up to 24 weeks in main stage; up to 96 weeks in extended stage
DRUG	Placebo	taking Placebo orally once daily, up to 24 weeks in main stage

Timeline

• Start date: 2023-02-15
• Primary completion: 2024-12-01
• Completion: 2026-12-01
• First posted: 2021-12-01
• Last updated: 2023-07-05

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study