Non-cystic Fibrosis BronchiectasisPhase 3NCT07616375
A Study to Assess the Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis
A Phase 3 study testing HSK31858, tablet in people with Non-cystic Fibrosis Bronchiectasis, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a phase III, single-arm, open-label, multicenter study to assess the safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- HSK31858, tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 669 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2025to 3 Apr 2029
- Phase
- Phase 3
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.Voluntarily sign the informed consent form; 2.Had previously participated in the HSK31858-301 study (having completed at least the randomization and having taken the first dose of medication); 3.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 throughout the study period.
- 4.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.
- 5. Males with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
Who cannot join
- 1.In the HSK31858-301 study, there were cases of serious adverse events related to the investigational drug or subjects who were assessed by the investigators as requiring permanent discontinuation of the treatment.
- 2. 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.
- 3.Pregnancy and lactation. 4.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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yixing People's Hospital, Yixing, Jiangxi Recruiting
Yixingcun, Jiangxi
Feng Yan Yan, 86-13812558080, staff622@Yxph.com
About this study
Official title: Phase 3 Single-arm, Open-label, Multicenter Study to Assess the Safety of HSK31858 in Participants With Non-cystic Fibrosis Bronchiectasis
This is a phase III, single-arm, open-label, multicenter study to assess the safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Being tested
- HSK31858, tablet
- Keywords
- non-cystic fibrosis bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK31858, tabletDrug
HSK31858 is a novel inhibitor of DPP1 developed by Hisco Pharmaceutical and can reduce pulmonary exacerbations over a 52-week treatment period in patients with non-cystic fibrosis bronchiectasis
| Study group | Role | What they receive |
|---|---|---|
| HSK31858 40mg | Experimental | HSK31858 40mg treat for 96-week Receives: Drug: HSK31858, tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Occurrence of adverse events
Measured: week 96
Secondary outcomes (4)
Frequency of pulmonary exacerbations
Measured: week 96
Change from Baseline(Screening) in forced expiratory volume in 1 second (FEV1)
Measured: week 96
Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire
score from 0 to 100
Measured: week 96
Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score
score from 0 to 8
Measured: week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start28 Sep 2025
- Primary completion10 Jan 2029 (estimated)
- Study completion3 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cystic Fibrosis BronchiectasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 669 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
- NCT07616375
- Sponsor's protocol ID
- HSK31858-302
- Status last verified
- Oct 2025
- First submitted
- 23 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided