Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06820749 | A Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Airway Mucus Hypersecretion | PHASE2 | ENROLLING BY_INVITATION | 309 | — | — | Dec 10, 2024 | Jun 22, 2026 | Feb 20, 2025 | 1 | China |
Change from baseline in 24 hour sputum weight after 12 weeks of treatment
| Arm | Type | Description |
|---|---|---|
| HSK31858 20mg | EXPERIMENTAL | multiple oral doses: 20mg/d for 12w |
| HSK31858 40mg | EXPERIMENTAL | multiple oral doses: 40mg/d for 12w |
| placebo | PLACEBO_COMPARATOR | multiple oral doses for 12w |
| Name | Type | Description |
|---|---|---|
| HSK31858 | DRUG | HSK31858 is a novel inhibitor of DPP1 developed by Hisco Pharmaceutical and can reduce pulmonary exacerbations over a 12-week treatment period in patients with airway mucus hypersecretion in chronic airway inflammatory diseases |
| Placebo | DRUG | the placebo comparator of study |
Inclusion Criteria: 1)Able to fully understand and voluntarily sign informed consent; 2)Male or female patients ≥18 years of age at the time of screening; 3)Patient with chronic airway inflammatory diseases (bronchiectasis, chronic obstructive pulmonary disease, asthma); 4)24h sputum volume ≥10ml a...