Asthma BronchialePhase 2NCT06820749
A Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Airway Mucus Hypersecretion
A Phase 2 study testing HSK31858 in people with Asthma Bronchiale and Bronchiectasis, 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 airway mucus hypersecretion in chronic airway inflammatory diseases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Bronchiale, Bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD)
- 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
- 309 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 22 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1)Able to fully understand and voluntarily sign informed consent; 2)Male or female patients ≥18 years of age at the time of screening; 3)Patient with chronic airway inflammatory diseases (bronchiectasis, chronic obstructive pulmonary disease, asthma); 4)24h sputum volume ≥10ml at screening period (V1) and baseline (V2); 5) If the subjects have used background therapy drugs, other background therapy drugs other than expectorant drugs were used to maintain stability for ≥1 month before screening; 6)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.
- 7)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
- Known allergic history to the active ingredient of the investigational drug or other drugs with similar chemical structure;
- FEV1 accounted for less than 30% of the estimated value after bronchodilator use;
- 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;
- Hemoptysis (other than a small amount of bloody sputum or a blood clot smaller than a fingernail) occurs within 4 weeks prior to screening and requires urgent medical intervention;
- Active infection or acute infection requiring systemic anti-infective therapy within 4 weeks prior to screening.
- 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;
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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);
- Participation in a clinical trial of any other drug or medical device (treated with a drug or medical device in a clinical trial) within 1 months prior to screening;
- Having received a drug that may cause hyperkeratosis of the skin (e.g., tumor necrosis factor alpha antagonist) within 4 weeks prior to screening;
- 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;
- 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;
- Asthmatic 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. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, 100020
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 Airway Mucus Hypersecretion in Chronic Airway Inflammatory Diseases
This is a phase II, randomised, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of HSK31858 in patients with airway mucus hypersecretion in chronic airway inflammatory diseases
- Being tested
- HSK31858, Placebo
- Medical subject headings
- Bronchiectasis, Pulmonary Disease, Chronic Obstructive
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 12-week treatment period in patients with airway mucus hypersecretion in chronic airway inflammatory diseases
PlaceboDrug
the placebo comparator of study
| Study group | Role | What they receive |
|---|---|---|
| HSK31858 20mg | Experimental | multiple oral doses: 20mg/d for 12w Receives: Drug: HSK31858 |
| HSK31858 40mg | Experimental | multiple oral doses: 40mg/d for 12w Receives: Drug: HSK31858 |
| placebo | Placebo comparator | multiple oral doses for 12w Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 24 hour sputum weight
Change from baseline in 24 hour sputum weight after 12 weeks of treatment
Measured: 12-week treatment period
Secondary outcomes (6)
Change from baseline in expectoration difficulty score
Change from baseline in expectoration difficulty score after 4, 8 and 12 weeks of treatment.The expectoration difficulty score adopt a 4-level evaluation standard, 0 points for no expectoration, 1 points for easy expectoration, 2 points for moderate expectoration difficulty, and 3 points for hardest expectoration.
Measured: 12-week treatment period
Change from baseline in sputum trait score
Change from baseline in sputum trait score after 4, 8, and 12 weeks of treatment.The sputum trait score was based on the Miller classification, according to the proportion of purulent part to total sputum volume.
Measured: 12-week treatment period
Change from baseline in sputum viscosity score
Change from baseline in sputum viscosity score after 4, 8, and 12 weeks of treatment.The sputum viscosity score is based on a 5-level evaluation standard. Sputum adhering to the cup wall of the container and not sliding down is 1 point; sputum slowly sliding through the cup wall of the container under the action of gravity is 2 points; sputum sliding in large pieces through the cup wall under the action of gravity is 3 points; sputum is easily poured out and a small amount of thin mucus sticks to the cup wall of the container. No residual sputum on the wall of the container 5 points.
Measured: 12-week treatment period
Change from baseline in cough severity score
Change from baseline in cough severity score after 4, 8, and 12 weeks of treatment.The visual analog scale (VAS) was used to score the severity of cough: a line 10 cm long was drawn on the white paper, and the corresponding scale was marked to indicate the severity of cough. The score was 0 to 10 points, 0 was no cough and no trouble to the patient, and 10 was the most serious cough and the most serious trouble to the patient.
Measured: 12-week treatment period
Change from baseline in cough and sputum assessment questionnaire
Change from baseline in cough and sputum assessment questionnaire after 4, 8, and 12 weeks of treatment.The cough and sputum assessment questionnaire is an evaluation tool used to evaluate the impact of cough and sputum on the quality of life of patients. The contents involved four dimensions: cough symptoms, cough effects, sputum symptoms and sputum effects. Each dimension contained different items, which were scored and statistically converted, with a total score of 100 points. The lower the score, the heavier airway mucus hypersecretion.
Measured: 12-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 12 week.
Measured: 12-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 posted11 Feb 2025
- Study start10 Dec 2024
- Primary completion23 Apr 2026 (estimated)
- Study completion22 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma BronchialeStudies 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
- 309 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
- NCT06820749
- Sponsor's protocol ID
- HSK31858-204
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. 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 Airway Mucus Hypersecretion in Chronic Airway Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT06820749
- Acronym / sponsor ID
- HSK31858-204
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 23 Apr 2026 (estimated)
- Study completion
- 22 Jun 2026 (estimated)
- First posted
- 11 Feb 2025 (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 airway mucus hypersecretion in chronic airway inflammatory diseases
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 12w |
| HSK31858 40mg | Experimental | Drug: HSK31858multiple oral doses: 40mg/d for 12w |
| placebo | Placebo comparator | Drug: Placebomultiple oral doses for 12w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1)Able to fully understand and voluntarily sign informed consent; 2)Male or female patients ≥18 years of age at the time of screening; 3)Patient with chronic airway inflammatory diseases (bronchiectasis, chronic obstructive pulmonary disease, asthma); 4)24h sputum volume ≥10ml at screening period (V1) and baseline (V2); 5) If the subjects have used background therapy drugs, other background therapy drugs other than expectorant drugs were used to maintain stability for ≥1 month before screening; 6)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.
- 7)Subjects are able to communicate well with the investigator and are able to complete the study in accordance with the protocol requirements.
Key exclusion criteria (22 listed)
- Known allergic history to the active ingredient of the investigational drug or other drugs with similar chemical structure;
- FEV1 accounted for less than 30% of the estimated value after bronchodilator use;
- 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;
- Hemoptysis (other than a small amount of bloody sputum or a blood clot smaller than a fingernail) occurs within 4 weeks prior to screening and requires urgent medical intervention;
- Active infection or acute infection requiring systemic anti-infective therapy 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 12-week treatment period in patients with airway mucus hypersecretion in chronic airway inflammatory diseases | Drug | HSK31858 20mg, HSK31858 40mg |
| Placebothe placebo comparator of study | Drug | placebo |
Primary outcome
Change from baseline in 24 hour sputum weight
Time frame: 12-week treatment period
Change from baseline in 24 hour sputum weight after 12 weeks of treatment
6 secondary outcomes
Change from baseline in expectoration difficulty score
Time frame: 12-week treatment period
Change from baseline in sputum trait score
Time frame: 12-week treatment period
Change from baseline in sputum viscosity score
Time frame: 12-week treatment period
Change from baseline in cough severity score
Time frame: 12-week treatment period
Change from baseline in cough and sputum assessment questionnaire
Time frame: 12-week treatment period
Change from Baseline in forced expiratory volume in 1 second (FEV1)
Time frame: 12-week treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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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.
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 Asthma Bronchiale and Bronchiectasis, 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 2 inclusion and 22 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: enrolling by invitation, as of the sponsor's last update on 20 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in 24 hour sputum weight (time frame: 12-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 20 Feb 2025.