This is a phase III, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.
1. Age ≥18 years and BMI≥18.0 kg/m² at the time of signing the ICF. 2. Chest HRCT showed bronchiectasis affecting one or more lobes and was confirmed by a clinician as NCFBE(clinically characterized by chronic cough, expectoration and/or intermittent hemoptysis, with or without shortness of breath and respiratory failure). HRCT was considered effective if the patient had received HRCT in the same hospital within 12 months and screening HRCT is not necessary.
1. Have a primary diagnosis of COPD or asthma as judged by the Investigator. 2. A history of malignancy (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary carcinoma of the thyroid gland. The patients who had survived lung cancer surgery for at least 5 years without antitumor therapy can enroll in the study ) within 5 years prior to screening or a history of antitumor therapy.
AST>2.0×ULN or ALT>2.0×ULN or TBIL>1.5×ULN
eGFR<60ml/min/1.73m2
Hb<90 g/L
Parallel
HSK31858, tablet
DrugHSK31858 is a novel inhibitor of DPP1 developed by Hisco Pharmaceutical and can reduce pulmonary exacerbations over a 52-week treatment period in patients with non-cystic fibrosis bronchiectasis
Placebo
Drugthe placebo comparator of study
Frequency of pulmonary exacerbations
Time to first pulmonary exacerbation
Change from Baseline(Screening) in forced expiratory volume in 1 second (FEV1)
Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score
score from 0 to 8
Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire
score from 0 to 100
Click on the lead sponsor to view all of their trials.
