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
NCT ID: NCT06981091
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
231 participants
INTERVENTIONAL
2025-05-16
2027-04-28
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: Participant Group
Participants received XH-S004 20 mg once daily (QD) , for 24 weeks.
XH-S004 20 mg
Administered once per day for 24 weeks.
Arm 2: Participant Group
Participants received XH-S004 40 mg once daily (QD) , for 24 weeks.
XH-S004 40 mg
Administered once per day for 24 weeks.
Arm 3: Participant Group
Participants received the matching placebo once daily (QD) , for 24 weeks.
Placebo
Administered once per day for 24 weeks.
Interventions
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XH-S004 20 mg
Administered once per day for 24 weeks.
XH-S004 40 mg
Administered once per day for 24 weeks.
Placebo
Administered once per day for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Male or female paticipants aged 18-85 years (inclusive) ;
3. 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);
4. 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;
5. 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) ;
6. The body mass index (BMI) is ≥18 kg/m2 at screening;
7. 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 Criteria
2. Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency
3. Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
4. Have any acute infections, (including respiratory infections)
5. Patients who have previously received therapy with DPP1 inhibitors of the same class
18 Years
85 Years
ALL
No
Sponsors
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S-INFINITY Pharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Huadong Hospital Affiliated to fudan univercity
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XH-S004-201
Identifier Type: -
Identifier Source: org_study_id
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