A Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Bronchial Asthma

NCT06637254 | Enrolling By Invitation Phase 2

• 1 other identifier: HSK31858-203
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

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

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• The annualized asthma exacerbation rate within 24 weeks

  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

  24-week treatment period

Secondary Outcomes (11)

• 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

Study Arms (3)

HSK31858 20mg

EXPERIMENTAL

multiple oral doses: 20mg/d for 48w

Drug: HSK31858

HSK31858 40mg

EXPERIMENTAL

multiple oral doses: 40mg/d for 48w

Drug: HSK31858

placebo

PLACEBO COMPARATOR

multiple oral doses for 48w

Drug: Placebo

Interventions

HSK31858 DRUG

HSK31858 is a novel inhibitor of DPP1 developed by Hisco Pharmaceutical and can reduce pulmonary exacerbations over a 48-week treatment period in patients with bronchial asthma

HSK31858 20mg; HSK31858 40mg

Placebo DRUG

the placebo comparator of study

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) ≥ 1.5.
• 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.

You may not qualify if:

• 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:
• White blood cell count \< 3 × 109/L, or neutrophil count\< 1.5 × 109/L, or platelet \< 70 × 109/L, or hemoglobin \< 90 g/L;
• Alanine aminotransferase (ALT) \> 2 × ULN (upper limit of normal), or aspartate aminotransferase (AST) \> 2 × ULN, or total bilirubin (TBIL) \> 1.5 × ULN;
• Patients with moderate to severe renal insufficiency (eGFR \< 60 ml/min/1.73m2, calculation of eGFR using the simplified MDRD equation);
• Screening positive for human immunodeficiency virus (HIV) or a positive syphilis antibody test, active hepatitis B virus infection (hepatitis B surface antigen positive and HBV-DNA load above the lower limit of detection) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA load above the lower limit of detection).
• Participation in a clinical trial of any other drug or medical device (treated with a drug or medical device in a clinical trial) within 3 months prior to screening.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: October 22, 2024
• Primary Completion: March 22, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)