Florensocatib in adults with bronchiectasis: the HOPE-BE trial protocol and baseline demographic characteristics.

BACKGROUND: Florensocatib (formerly known as HSK31858) is a novel reversible inhibitor of dipeptidyl peptidase 1. We sought to determine the efficacy and safety of florensocatib in decreasing exacerbation frequency in Chinese adults with bronchiectasis. METHODS: The HOPE-BE trial was a phase 3, randomised, placebo-controlled trial which determines the efficacy and safety of high-dose florensocatib (40 mg once daily) versus placebo in Chinese adults with bronchiectasis who had two or more exacerbations within the past year. Patients were randomly assigned in a 2:1 ratio to receive florensocatib 40 mg or matching placebo once daily for 52 weeks. We recorded demographics, medical history, bacterial infection status and quality-of-life and performed spirometry at baseline. RESULTS: We randomised 700 patients who were enrolled from 67 sites in mainland China between September 2024 and November 2025. 60.4% of patients were female. 559 (79.9%) and 141 (20.1%) of patients, respectively, had two and three or more exacerbations in the past year. The median (interquartile range) of 24-h sputum weight was 14.8 (29.3) g, and the median (interquartile range) of sputum purulence score was 5.0 (2.0). 192 (27.4%) patients were culture positive to Pseudomonas aeruginosa, and demonstrated significantly higher 24-h sputum volume and purulence score, and lower lung function and quality-of-life scores. Significant geographical variations were seen regarding comorbidity, blood eosinophil counts and sputum bacteriology. CONCLUSION: The baseline demographic characteristics of the HOPE-BE trial may provide important clues to future therapeutic efficacy assessment in adults with bronchiectasis.