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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XH-S004 20 mg, XH-S004 40 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Non-Cystic Fibrosis Bronchiectasis. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period [Time frame: Baseline (Day 1) to Week 24]
Secondary outcome measures (5)
- Incidence of pulmonary exacerbation as defined by EMBARC over 24-week treatment period. [Time frame: Baseline (Day 1) to Week 24]
- Incidence of Pulmonary exacerbation as defined by investigators over 24-week treatment period. [Time frame: Baseline (Day 1) to Week 24]
- Change from baseline in forced expiratory volume in 1 second (FEV1) in pulmonary function test at week 24 after first drug administration. [Time frame: At baseline and at week 24]
- Change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOLB) respiratory symptoms domain score at week 24 after first drug administration; [Time frame: At baseline and at week 24]
- Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum [Time frame: Baseline (Day 1) to Week 24]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Huadong Hospital Affiliated to fudan univercity — Shanghai
Identifiers
NCT: NCT06981091 · XH-S004-201