Bronchial AsthmaPhase 2NCT06637254
A Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Bronchial Asthma
A Phase 2 study testing HSK31858 in people with Bronchial Asthma, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- HSK31858
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2024to 20 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Have undergone bronchial thermoplasty within 12 months prior to screening or plan to undergo this treatment during the study period.
- Currently using or have used anti-interleukin-5 (IL-5) monoclonal antibody, anti-interleukin-4/13 (IL-4/13) monoclonal antibody, anti-interleukin-4 receptor (IL-4R) monoclonal antibody, anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonal antibody within 12 weeks prior to screening or within 5 half-lives of the drug, whichever is longer.
- Patients who have previously received treatment with HSK31858 tablets or similar products of DPP1 inhibitors.
- Patients who have used a strong inducer or inhibitor of CYP3A within 14 days or 5 half-lives prior to the first investigational product administration, whichever is longer.
- Having received a drug that may cause hyperkeratosis of the skin (e.g., tumor necrosis factor alpha antagonist) within 4 weeks prior to screening.
- Comorbidities associated with the development of non-hereditary palmoplantar keratoderma (e.g., myxedema, chronic lymphoedema).
- Comorbid periodontal disease that, in the judgement of the investigator, has an impact on the study.
- Currently smoking subjects or subjects who quit smoking within 6 months prior to the screening visit; previous smoking subjects with a smoking history >10 pack-year = packs per day × years of smoking (Note: 1 pack = 20 cigarettes, 10 pack-year = 1 pack/day × 10 years or 1/2 pack/day × 20 years).
- History of drug use, or substance abuse within 2 years prior to screening.
- Pregnant, or planning to become pregnant during the study, or breastfeeding.
- Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Bronchial Asthma
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
- Being tested
- HSK31858, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK31858Drug
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
PlaceboDrug
the placebo comparator of study
| Study group | Role | What they receive |
|---|---|---|
| HSK31858 20mg | Experimental | multiple oral doses: 20mg/d for 48w Receives: Drug: HSK31858 |
| HSK31858 40mg | Experimental | multiple oral doses: 40mg/d for 48w Receives: Drug: HSK31858 |
| placebo | Placebo comparator | multiple oral doses for 48w Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24-week treatment period
Secondary outcomes (11)
The annualized asthma exacerbation rate within 48 weeks
Total number of acute exacerbations of bronchial asthma occurring within 48 weeks of study dosing / actual length of follow-up within 48 weeks of dosing
Measured: 48-week treatment period
Time to first acute exacerbation of bronchial asthma
Length of time from randomization to first acute exacerbation of bronchial asthma within 48 weeks of treatment
Measured: 48-week treatment period
Change from Baseline in forced expiratory volume in 1 second (FEV1)
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at each clinical visit during the treatment period
Measured: 48-week treatment period
Change from baseline in peak expiratory flow(PEF)
Change from baseline in peak expiratory flow (PEF) at each clinical visit during the treatment period
Measured: 48-week treatment period
Change from baseline in Asthma Control Test (ACT)
Change from baseline in Asthma Control Test (ACT) score at each clinical visit during the treatment period.The ACT score is a questionnaire designed to assess the level of asthma control, including the impact of asthma on daily life, number of breathlessness episodes, asthma symptoms, use of rescue medication, and self-assessment of asthma control. The ACT score is a questionnaire designed to assess the level of asthma control, including the impact of asthma on daily life, number of breathlessness episodes, asthma symptoms, use of rescue medication, and self-assessment of asthma control.
Measured: 48-week treatment period
Change from baseline in the 5-item Asthma Control Questionnaire (ACQ-5)
Change from baseline in the 5-item Asthma Control Questionnaire (ACQ-5) score at each clinical visit during the treatment period.5-item Asthma Control Questionnaire(ACQ-5) is a scoring scale used to assess asthma control in patients over the past week. It addresses asthma-related symptoms and consists of five items, each scored on a scale of 0 to 6, with higher scores indicating poorer control。Take the average score of 5 questions: <0.75 points indicate that asthma has been fully controlled; a score between 0.75 and 1.5 indicates that asthma is well controlled; and a score of >1.5 indicates that asthma is not controlled.
Measured: 48-week treatment period
Change from baseline in 24-h sputum weight
Change from baseline in 24-h sputum weight at each clinical visit during the treatment period
Measured: 48-week treatment period
The number of puffs of rescue medication used
The number of puffs of rescue medication used at each clinical visit during the treatment period
Measured: 48-week treatment period
Change from baseline in Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)
Change from baseline in Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) scores after 12, 24, 36, and 48 weeks of treatment.The Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) is dedicated to assessing the quality of daily life in adults with asthma. The Asthma Quality of Life Questionnaire is a 7-point scale, with 1 indicating the worst and 7 the best. The sum of each item scores is the total score. The maximum total score is 105, with higher scores indicating better asthma control and lower scores indicating poorer quality of life.
Measured: 48-week treatment period
The proportion of patients without acute exacerbation of bronchial asthma
The proportion of patients without acute exacerbation of bronchial asthma after 24 and 48 weeks of treatment
Measured: 48-week treatment period
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC) after 24 and 48 weeks of treatment.The PGIC scale is an assessment of the overall change in the patient's condition since the start of the study and is rated on a 7-point scale: a score of 1 represents extreme improvement, 2 represents significant improvement, 3 represents slight improvement, 4 represents no improvement, 5 represents slight deterioration, 6 represents significant deterioration and 7 represents critical deterioration.
Measured: 48-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start22 Oct 2024
- Primary completion22 Mar 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637254
- Sponsor's protocol ID
- HSK31858-203
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Bronchial Asthma
- ClinicalTrials.gov ID
- NCT06637254
- Acronym / sponsor ID
- HSK31858-203
- Conditions
- Bronchial Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 22 Mar 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HSK31858 20mg | Experimental | Drug: HSK31858multiple oral doses: 20mg/d for 48w |
| HSK31858 40mg | Experimental | Drug: HSK31858multiple oral doses: 40mg/d for 48w |
| placebo | Placebo comparator | Drug: Placebomultiple oral doses for 48w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK31858HSK31858 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 | Drug | HSK31858 20mg, HSK31858 40mg |
| Placebothe placebo comparator of study | Drug | placebo |
Primary outcome
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
11 secondary outcomes
The annualized asthma exacerbation rate within 48 weeks
Time frame: 48-week treatment period
Time to first acute exacerbation of bronchial asthma
Time frame: 48-week treatment period
Change from Baseline in forced expiratory volume in 1 second (FEV1)
Time frame: 48-week treatment period
Change from baseline in peak expiratory flow(PEF)
Time frame: 48-week treatment period
Change from baseline in Asthma Control Test (ACT)
Time frame: 48-week treatment period
Change from baseline in the 5-item Asthma Control Questionnaire (ACQ-5)
Time frame: 48-week treatment period
Change from baseline in 24-h sputum weight
Time frame: 48-week treatment period
The number of puffs of rescue medication used
Time frame: 48-week treatment period
Change from baseline in Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)
Time frame: 48-week treatment period
The proportion of patients without acute exacerbation of bronchial asthma
Time frame: 48-week treatment period
Patient Global Impression of Change (PGIC)
Time frame: 48-week treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK31858 in people with Bronchial Asthma, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The annualized asthma exacerbation rate within 24 weeks (time frame: 24-week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.