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

NCT06981091 | Not Yet Recruiting Phase 2

• 1 other identifier: XH-S004-201
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Cystic Fibrosis Bronchiectasis

Keywords

Bronchiectasis; Active neutrophil elastase; Fibrosis

Outcome Measures

Primary Outcomes (1)

• Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period

  Time to first pulmonary exacerbation was calculated as the number of days from the date of randomization to the date of first documentation of an exacerbation. Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics (EMBARC guideline) : 1. Increased cough 2. Increased sputum volume 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis.

  Baseline (Day 1) to Week 24

Secondary Outcomes (5)

• Incidence of pulmonary exacerbation as defined by EMBARC over 24-week treatment period.

  Baseline (Day 1) to Week 24

• Incidence of Pulmonary exacerbation as defined by investigators over 24-week treatment period.

  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.

  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;

  At baseline and at week 24

• Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum

  Baseline (Day 1) to Week 24

Study Arms (3)

Arm 1: Participant Group

EXPERIMENTAL

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

Other: XH-S004 20 mg

Arm 2: Participant Group

EXPERIMENTAL

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

Other: XH-S004 40 mg

Arm 3: Participant Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

XH-S004 20 mg OTHER

Administered once per day for 24 weeks.

Arm 1: Participant Group

XH-S004 40 mg OTHER

Administered once per day for 24 weeks.

Arm 2: Participant Group

Placebo OTHER

Administered once per day for 24 weeks.

Arm 3: Participant Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• S-INFINITY Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Huadong Hospital Affiliated to fudan univercity

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Bronchiectasis; Fibrosis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jinfu Xu, Doctor degree

CONTACT

86-13321922898; jfxucn@163.com

Yinggang Zhu, Doctor degree

CONTACT

86-13917543210; robinzyg-zhu@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): January 8, 2027
• Study Completion (Estimated): April 28, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)