Phase 3 Study of HSK31858 to Treat Adults With Non-Cystic Fibrosis Bronchiectasis Randomized, Double-Blind, Placebo-Controlled Multicenter Trial

What this Trial Is About

Researchers are evaluating the efficacy and safety of HSK31858, a novel DPP1 inhibitor, in adults with non-cystic fibrosis bronchiectasis NCFBE. This phase III, randomized, double-blind, placebo-controlled, multicenter study aims to reduce pulmonary exacerbations in participants who have experienced at least two exacerbations in the past year. The study is sponsored by Haisco Pharmaceutical Group Co., Ltd. and focuses on a population with confirmed bronchiectasis affecting one or more lung lobes, excluding those with cystic fibrosis or certain other lung diseases. Participants will be randomly assigned to receive either HSK31858 40 mg tablets or a placebo for 52 weeks. The treatment is administered orally once daily. The study includes a placebo comparator group to evaluate the effects of HSK31858 against no active treatment. The trial also requires stable dosing of any long-term bronchodilator therapies during the study period. During the 52-week study, participants will be monitored regularly for pulmonary exacerbations and lung function changes using measures such as forced expiratory volume in 1 second FEV1, sputum weight, sputum purulence, and quality of life assessments specific to bronchiectasis symptoms. Safety will be assessed throughout the trial, and participants will be followed closely to evaluate treatment outcomes and adverse effects. Total participation duration is approximately one year, including screening and treatment.

A Study to Assess the Efficacy and Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis