Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
S-INFINITY Pharmaceuticals Co., Ltd
Conditions:
Non-Cystic Fibrosis Bronchiectasis
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 pharmacodyn...
Eligibility Criteria
Inclusion
- Understand the procedures and methods of this trial and sign a written informed consent form;
- Male or female paticipants aged 18-85 years (inclusive) ;
- Chest HRCT shows bronchiectasis affecting one or more lobes, and the condition is clinically diagnosed as non-cystic fibrosis bronchiectasis (clinical manifestations include chronic cough, significant productive cough, and/or intermittent hemoptysis, with or without varying degrees of polypnoea and other symptoms);
- Based on medical history and the determination of the investigator , participants have at least 2 documented pulmonary exacerbations in the past 12 months before Screening;
- Are current sputum producers with a history of chronic expectoration and able to provide a spontaneous sputum sample at screening visit (as described by the patient) ;
- The body mass index (BMI) is ≥18 kg/m2 at screening;
- Participants must ensure and agree that from 28 days prior to signing the informed consent form to 28 days after the final administration, women of childbearing potential, male participants, and their partners will use effective contraception methods other than oral drugs (e.g., condoms or intra-uterine contraceptive devices) and will not donate sperm or eggs during this period
Exclusion
- Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
- Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency
- Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
- Have any acute infections, (including respiratory infections)
- Patients who have previously received therapy with DPP1 inhibitors of the same class
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 28 2027
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT06981091
Start Date
May 16 2025
End Date
April 28 2027
Last Update
May 20 2025
Active Locations (1)
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1
Huadong Hospital Affiliated to fudan univercity
Shanghai, Shanghai Municipality, China, 200040