NCT06981091

A Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of XH-S004 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 231 (estimated)
• Sponsor: S-INFINITY Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if XH-S004 can reduce pulmanary exacerbation over a 24-week treatment duration in participants with non-cystic fibrosis bronchiectasis.

Detailed description

This study is a multicenter, double-blind, placebo-controlled, parallel-group study conducted in china, aimed at evaluating the efficacy, safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of XH-S004 administered once daily for 24 weeks in participants with non-cystic fibrosis bronchiectasis (NCFBE). This study plans to enroll 231 patients with bronchiectasis. Patients who sign the informed consent form will be screened according to the enrollment criteria, and randomly divided into 3 groups. Participants in groups 1 and 2 will receive different doses of XH-S004. Participants in group 3 will receive placebo.

Conditions

• Non-Cystic Fibrosis Bronchiectasis

Interventions

Type	Name	Description
OTHER	XH-S004 20 mg	Administered once per day for 24 weeks.
OTHER	XH-S004 40 mg	Administered once per day for 24 weeks.
OTHER	Placebo	Administered once per day for 24 weeks.

Timeline

• Start date: 2025-05-16
• Primary completion: 2027-01-08
• Completion: 2027-04-28
• First posted: 2025-05-20
• Last updated: 2025-05-20

Locations

1 site across 1 country: China