Phase III Study of HEC585 Tablets Compared to Placebo and Pirfenidone for Treating Idiopathic Pulmonary Fibrosis IPF in Adults Aged 40 to 80

What this Trial Is About

Researchers are conducting a Phase III clinical trial to study idiopathic pulmonary fibrosis IPF, a lung disease that causes scarring and breathing difficulties. This randomized, placebo-controlled, and active comparator-controlled study evaluates the safety and effectiveness of the drug HEC585 in patients with IPF. The trial is sponsored by Sunshine Lake Pharma Co., Ltd. and aims to provide important information about treatment options for this condition. Participants will be assigned to one of three groups one receiving HEC585 tablets once daily, another receiving a placebo tablet once daily, and a third group receiving pirfenidone three times daily as an active comparator. The study is designed with a double-blind placebo arm and an open-label pirfenidone arm to compare outcomes over the study duration. Treatments will be taken as directed, and participants will be monitored carefully throughout the trial. During the study, participants will undergo regular assessments including lung function tests like forced vital capacity FVC, diffusion capacity of the lung for carbon monoxide DLco, and a six-minute walk test to measure exercise tolerance. Quality of life will be evaluated using the St Georges Respiratory Questionnaire SGRQ. The primary outcome focuses on the change in FVC after 52 weeks. Researchers will also monitor safety and any clinical events during this period. The total study duration extends through the planned follow-up until February 2032.

Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF