A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Bronchial Asthma

Haisco Pharmaceutical Group Co., Ltd.1 site in 1 country219 target enrollmentOctober 22, 2024

ConditionsBronchial Asthma

InterventionsHSK31858 Placebo

DrugsHSK31858 Placebo

Overview

Phase: Phase 2
Intervention: HSK31858
Conditions: Bronchial Asthma
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Enrollment: 219
Locations: 1
Primary Endpoint: The annualized asthma exacerbation rate within 24 weeks
Status: Enrolling By Invitation
Last Updated: last year

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 patients with bronchial asthma

Registry

clinicaltrials.gov

Start Date

October 22, 2024

End Date

September 20, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily sign the informed consent form.
•Male or female patients aged ≥18 and ≤75 years at screening, weighing ≥40 kg.
•Diagnosis of typical asthma and their history of asthma is ≥12 months at screening (provide a traceable record of asthma diagnosis).
•Have been treated for ≥3 consecutive months prior to screening with a moderate-to-high daily dose of inhaled corticosteroids (ICS) in combination with at least one other asthma-controlling medication, and have remained stable for ≥1 month prior to screening.
•Have had ≥1 acute exacerbation of asthma in the 12 months prior to screening.
•Screening period (V1) pre-bronchodilator FEV1 \<80% of predicted value.
•Screening period (V1) 5-item Asthma Control Questionnaire (ACQ-5) ≥ 1.
•Screening period (V1) blood eosinophil count \<150/μL.
•Female subjects with fertility or male subjects whose partner is a female with fertility must agree to have no plans to have children and to use contraception voluntarily from the time of signing the informed consent form until 3 months after the last dose. All females of childbearing potential must have a negative screening pregnancy test.
•Subjects are able to communicate well with the investigator and are able to complete the study in accordance with the protocol requirements.

Exclusion Criteria

•Requires long-term oral corticosteroid maintenance therapy.
•Subjects also have other lung diseases, including chronic obstructive pulmonary disease, bronchiectasis, and pulmonary fibrosis, not dominated by asthma as determined by the investigator.
•Comorbid with other diseases that are clinically significant and may affect lung function, including but not limited to pleural disease, mediastinal disease, diaphragmatic lesions, myasthenia, and thoracic deformities.
•History of malignancy: subjects with basal cell carcinoma, limited squamous cell carcinoma of the skin, or cervical carcinoma in situ will be allowed to enter the study if curative treatment has been completed for at least 12 months prior to signing the informed consent form; subjects with other malignancies will be allowed to enter the study if curative treatment has been completed for at least 5 years prior to signing the informed consent form.
•Patients who have experienced any degree of acute exacerbation of asthma or are experiencing an acute exacerbation of asthma within 4 weeks prior to screening.
•Active infection or acute infection requiring systemic anti-infective therapy within 4 weeks prior to screening.
•Presence of any severe and/or uncontrolled medical condition that, in the judgement of the investigator, affects the safety of the subject or interferes with the evaluation of the medication, including, but not limited to: severe neurological disease, history of serious mental disorders, major cardiovascular disease, diabetes mellitus that is poorly controlled on standardized therapy, presence of prolonged QTcF interval or cardiac arrhythmia, or immunodeficiency disorders.
•Subjects with a history of liver disease or currently receiving treatment for liver disease during the screening period, including but not limited to acute and chronic hepatitis, cirrhosis or liver failure.
•Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg, and/or diastolic blood pressure ≥ 100 mmHg at screening or baseline).
•Abnormal screening and baseline laboratory tests:

Arms & Interventions

HSK31858 20mg

multiple oral doses: 20mg/d for 48w

Intervention: HSK31858

HSK31858 40mg

multiple oral doses: 40mg/d for 48w

Intervention: HSK31858

placebo

multiple oral doses for 48w

Intervention: Placebo

Outcomes

Primary Outcomes

The annualized asthma exacerbation rate within 24 weeks

Time Frame: 24-week treatment period

Total number of acute exacerbations of bronchial asthma occurring within 24 weeks of study dosing / actual length of follow-up within 24 weeks of dosing

Secondary Outcomes

The annualized asthma exacerbation rate within 48 weeks(48-week treatment period)
Time to first acute exacerbation of bronchial asthma(48-week treatment period)
Change from Baseline in forced expiratory volume in 1 second (FEV1)(48-week treatment period)
Change from baseline in peak expiratory flow(PEF)(48-week treatment period)
Change from baseline in Asthma Control Test (ACT)(48-week treatment period)
Change from baseline in the 5-item Asthma Control Questionnaire (ACQ-5)(48-week treatment period)
Change from baseline in 24-h sputum weight(48-week treatment period)
The number of puffs of rescue medication used(48-week treatment period)
Change from baseline in Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)(48-week treatment period)
The proportion of patients without acute exacerbation of bronchial asthma(48-week treatment period)
Patient Global Impression of Change (PGIC)(48-week treatment period)