Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of HSK31858 in Participants With Non-cystic Fibrosis Bronchiectasis

Haisco Pharmaceutical Group Co., Ltd.1 site in 1 country210 target enrollmentDecember 6, 2022

ConditionsNon-cystic Fibrosis Bronchiectasis (NCFBE)

InterventionsHSK31858 placebo

DrugsHSK31858 placebo

Overview

Phase: Phase 2
Intervention: HSK31858
Conditions: Non-cystic Fibrosis Bronchiectasis (NCFBE)
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Enrollment: 210
Locations: 1
Primary Endpoint: Frequency of pulmonary exacerbations
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase II, randomised, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.

Registry

clinicaltrials.gov

Start Date

December 6, 2022

End Date

February 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years and BMI≥18.0 kg/m\^2 at the time of signing the ICF.
•Chest HRCT showed bronchiectasis affecting one or more lobes and was confirmed by a clinician as NCFBE(clinically characterized by chronic cough, expectoration and/or intermittent hemoptysis, with or without shortness of breath and respiratory failure). HRCT was considered effective if the patient had received HRCT in the same hospital within 12 months and screening HRCT is not necessary.
•Having daily expectoration(with sufficient sputum production at screening, if the subject is unable to produce sputum voluntarily, sample collection can be performed by induced expectoration).
•Have at least 2 pulmonary exacerbations in the past 12 months before Screening.
•If long-term treatment with bronchodilators (long-acting β-agonists and/or long-acting muscarinic antagonists) is required, the dose and regimen should remain stable for at least 3 months before the screening visit and throughout the study period.
•The estimated survival time ≥ 12 months.
•Women must be post-menopausal, surgically sterile, or using highly effective contraception methods from Day 1 to at least 30 days after the last dose.
•Males with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
•Give their signed study informed consent to participate.

Exclusion Criteria

•Have pulmonary hypertension or have a primary diagnosis of COPD or asthma as judged by the Investigator.
•A history of malignancy (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary carcinoma of the thyroid gland. The patients who had survived lung cancer surgery for at least 5 years without antitumor therapy can enroll in the study ) within 5 years prior to screening or a history of antitumor therapy.
•Have bronchiectasis due to CF (HRCT showed that the above lung diseases became predominant) as judged by the Investigator.
•Currently being treated Non-tuberculous Mycobacterial (NTM) pulmonary infections, allergic bronchopulmonary aspergillosis, or tuberculosis (TB), or active and currently symptomatic infections caused by COVID-
•Patients who had experienced any degree of acute exacerbation of bronchiectasis or were developing an acute exacerbation of bronchiectasis before 4 weeks of screening.
•Patients who had hemoptysis and required medical intervention within 4 weeks prior to screening(except for coughing up minorbloody streaks).
•Have an abnormal renal function test result (estimated glomerular filtration rate \[eGFR\] \< 60 mL/min/1.73m\^2) at Screening.
•Subjects with a history of liver disease or current treatment for liver disease during the screening period, including but not limited to acute or chronic hepatitis, cirrhosis or liver failure, or aspartate aminotransferase (AST) \> 2.0×ULN or alanine aminotransferase (ALT) \> 2.0×ULN or total bilirubin (TBIL) \> 1.5×ULN.
•Active hepatitis B virus infection (hepatitis B surface antigen positive with HBV-DNA load above the lower limit of detection), active hepatitis C virus infection (HCV antibody positive with HCV-RNA load above the lower limit of detection), or known HIV infection or syphilis infection.
•Any other unstable clinical condition, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, psychiatric, or major physiological dysfunction, that the investigator considers to be (a) likely to affect patient safety throughout the study; (b) Influence the results of the study and its interpretation; (c) impeding the patient's ability to complete the entire study.

Arms & Interventions

HSK31858 20mg

multiple oral doses: 20mg/d for 24w

Intervention: HSK31858

HSK31858 40mg

multiple oral doses: 20mg/d for 24w

Intervention: HSK31858

placebo

multiple oral doses for 24w

Intervention: placebo

Outcomes

Primary Outcomes

Frequency of pulmonary exacerbations

Time Frame: 24-week treatment period

Number of events per person-time over 24-weeks

Secondary Outcomes

Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score(24-week treatment period)
Change from Baseline(Screening) in Frequency of Hemoptysis(24-week treatment period)
Change from Baseline(Screening) in forced expiratory volume in 1 second (FEV1)(24-week treatment period)
Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire(24-week treatment period)
Time to first pulmonary exacerbation(24-week treatment period)