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Non-cystic Fibrosis Bronchiectasis (NCFBE)Phase 2NCT05601778

A Study of HSK31858 in Participants with Non-Cystic Fibrosis Bronchiectasis

A Phase 2 study testing HSK31858 in people with Non-cystic Fibrosis Bronchiectasis (NCFBE), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
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
226 participants
Where
1 siteChina
Study dates
6 Dec 2022to 7 Jun 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age ≥18 years and BMI≥18.0 kg/m^2 at the time of signing the ICF.
  • 2. 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.
  • 3. 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).
  • 4. Have at least 2 pulmonary exacerbations in the past 12 months before Screening.
  • 5. 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.
  • 6. The estimated survival time ≥ 12 months.
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  • 7. 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.
  • 8. Males with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
  • 9. Give their signed study informed consent to participate.

Who cannot join

  • 1. Have pulmonary hypertension or have a primary diagnosis of COPD or asthma as judged by the Investigator.
  • 2. 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.
  • 3. Have bronchiectasis due to CF (HRCT showed that the above lung diseases became predominant) as judged by the Investigator.
  • 4. Currently being treated Non-tuberculous Mycobacterial (NTM) pulmonary infections, allergic bronchopulmonary aspergillosis, or tuberculosis (TB), or active and currently symptomatic infections caused by COVID-19.
  • 5. Patients who had experienced any degree of acute exacerbation of bronchiectasis or were developing an acute exacerbation of bronchiectasis before 4 weeks of screening.
  • 6. Patients who had hemoptysis and required medical intervention within 4 weeks prior to screening(except for coughing up minorbloody streaks).
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  • 7. Have an abnormal renal function test result (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m^2) at Screening.
  • 8. 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.
  • 9. 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.
  • 10. 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.
  • 11. Had participated in a clinical trial of any other drug or medical device in the 3 months prior to the screening (a drug or medical device treated with a clinical trial) or the subject had not been more than 5 half-lives from the last clinical trial of the drug at the time of screening.
  • 12. Medications that may cause hyperkeratosis (e.g., tumor necrosis factor-α antagonists) within 4 weeks prior to screening.
  • 13. Patients who have used a strong inducer or suppressor of CYP3A within 14 days or 5 half-lives of the first investigational drug (whichever is longer).
  • 14. Patients who had smoked an average of 10 cigarettes or more per day in the previous 1 year were screened.
  • 15. Pregnancy and lactation.
  • 16. The subjects were unable to complete the questionnaires due to their limited educational level, or the subjects and their families failed to fill in the subjects' log cards.
  • 17. Had received live attenuated vaccine within 30 days before randomization. 18. The investigators judged that there were other conditions that were not suitable for participation in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

Other trials in China

About this study

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

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.

Being tested
HSK31858, placebo
Keywords
HSK31858, NCFBE, phase II

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 24-week treatment period in patients with non-cystic fibrosis bronchiectasis

  • placeboDrug

    the placebo comparator of study

Study groups in NCT05601778
Study groupRoleWhat they receive
HSK31858 20mgExperimentalmultiple oral doses: 20mg/d for 24w
Receives: Drug: HSK31858
HSK31858 40mgExperimentalmultiple oral doses: 20mg/d for 24w
Receives: Drug: HSK31858
placeboPlacebo comparatormultiple oral doses for 24w
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of pulmonary exacerbations

    Number of events per person-time over 24-weeks

    Measured: 24-week treatment period

Secondary outcomes (5)

  1. Time to first pulmonary exacerbation

    Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics

    Measured: 24-week treatment period

  2. Change from Baseline(Screening) in forced expiratory volume in 1 second (FEV1)

    Change from Baseline(Screening) in FEV1 at 24-weeks

    Measured: 24-week treatment period

  3. Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score

    Change from Baseline(Screening) in 24h Sputum Weight and Purulence Score at 24-weeks

    Measured: 24-week treatment period

  4. Change from Baseline(Screening) in Frequency of Hemoptysis

    Change from Baseline(Screening) in Hemoptysis

    Measured: 24-week treatment period

  5. Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire

    Change from Baseline Quality of Life (QOL) Bronchiectasis questionnairescore at 24-weeks

    Measured: 24-week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2022
  2. Study start6 Dec 2022
  3. Primary completion29 Mar 2024
  4. Study completion7 Jun 2024

Resources

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
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05601778
Sponsor's protocol ID
HSK31858-201
Status last verified
Sep 2024
First submitted
27 Oct 2022
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. doi: 10.1056/NEJMra012519. No abstract available.

    PubMed 11986413

  • Chalmers JD, Aliberti S, Filonenko A, Shteinberg M, Goeminne PC, Hill AT, Fardon TC, Obradovic D, Gerlinger C, Sotgiu G, Operschall E, Rutherford RM, Dimakou K, Polverino E, De Soyza A, McDonnell MJ. Characterization of the "Frequent Exacerbator Phenotype" in Bronchiectasis. Am J Respir Crit Care Med. 2018 Jun 1;197(11):1410-1420. doi: 10.1164/rccm.201711-2202OC.

    PubMed 29357265

  • Zhong NS, Qiu R, Cao J, Huang YM, Zhou H, Xu XX, Xu JF, Ye H, Yang ZR, Gao LY, Shen Y, Xiao ZK, Xie SG, Lin DJ, Zhao L, Xiong H, Zhang XM, Li FQ, Guan WJ, Chalmers JD; SAVE-BE trial investigators. Effects of the DPP-1 inhibitor HSK31858 in adults with bronchiectasis in China (SAVE-BE): a phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet Respir Med. 2025 May;13(5):414-424. doi: 10.1016/S2213-2600(25)00019-0. Epub 2025 Mar 25.

    PubMed 40154523

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HSK31858 in people with Non-cystic Fibrosis Bronchiectasis (NCFBE), 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 9 inclusion and 17 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: finished, as of the sponsor's last update on 26 Sep 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Frequency of pulmonary exacerbations (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?

On the ClinicalTrials.gov record for NCT05601778, which also lists 3 linked publications.

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 26 Sep 2024.

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