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

S-INFINITY Pharmaceuticals Co., Ltd

Status and phase: Not yet enrolling; Phase 2

Conditions: Non-Cystic Fibrosis Bronchiectasis

Treatments: Other: XH-S004 40 mg; Other: XH-S004 20 mg; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06981091

XH-S004-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 231 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Understand the procedures and methods of this trial and sign a written informed consent form;
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

1. Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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231 participants in 3 patient groups, including a placebo group

Arm 1: Participant Group

Experimental group

Description:

Participants received XH-S004 20 mg once daily (QD) , for 24 weeks.

Treatment:

Other: XH-S004 20 mg

Arm 2: Participant Group

Experimental group

Description:

Participants received XH-S004 40 mg once daily (QD) , for 24 weeks.

Treatment:

Other: XH-S004 40 mg

Arm 3: Participant Group

Placebo Comparator group

Description:

Participants received the matching placebo once daily (QD) , for 24 weeks.

Treatment:

Other: Placebo