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RECRUITING
NCT05139719
PHASE2

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

Sponsor: Sunshine Lake Pharma Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2023-02-15

Completion Date

2026-12

Last Updated

2023-07-05

Healthy Volunteers

No

Interventions

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

Locations (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China