Actively Recruiting
A Study to Assess the Efficacy and Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2024-10-28
669
Participants Needed
2
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.
CONDITIONS
Official Title
A Study to Assess the Efficacy and Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with a body mass index of 18.0 kg/m2 or higher at consent
- Chest HRCT showing bronchiectasis affecting one or more lobes confirmed as non-cystic fibrosis bronchiectasis by a clinician
- At least 2 pulmonary exacerbations in the 12 months before screening
- Stable dose and regimen of long-acting bronchodilators for at least 3 months before screening, if applicable
- Estimated survival time of 12 months or more
- Women must be post-menopausal, surgically sterile, or using effective contraception from Day 1 to 30 days after last dose
- Males with female partners of childbearing potential must use effective contraception from Day 1 to 90 days after last dose
- Signed informed consent provided
You will not qualify if you...
- Primary diagnosis of COPD or asthma
- History of malignancy within 5 years prior to screening, except certain cured cancers
- Bronchiectasis due to cystic fibrosis as judged by the investigator
- Current treatment for non-tuberculous mycobacterial infections, allergic bronchopulmonary aspergillosis, tuberculosis, active COVID-19 infection, or history of bronchopulmonary aspergillosis
- Severe pulmonary fibrosis, lung destruction, pneumonectomy history, pneumoconiosis, or decompensated pulmonary heart disease
- Acute bronchiectasis exacerbation within 4 weeks before screening
- Hemoptysis requiring medical intervention within 4 weeks before screening (except minor bloody streaks)
- Previous treatment with HSK31858 or other DPP1 inhibitors
- Uncontrolled hypertension (SBP ≥180 mmHg and/or DBP ≥110 mmHg)
- Uncontrolled diabetes (fasting plasma glucose >7.0 mmol/L)
- History or current liver disease during screening, excluding mild to moderate non-alcoholic fatty liver disease
- Active hepatitis B or C infection, HIV, or syphilis
- Any unstable clinical condition affecting safety or study results
- Abnormal laboratory test results meeting exclusion thresholds
- Participation in another clinical trial within 3 months before screening
- Use of medications causing hyperkeratosis within 4 weeks before screening
- Use of strong CYP3A inducers or suppressors within 14 days or 5 half-lives before first dose
- Smoking 10 or more cigarettes per day in the past year
- Pregnancy or breastfeeding
- Inability to complete questionnaires or maintain study logs
- Live attenuated vaccine within 30 days before randomization
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
2
Yixing People's Hospital
Yixingcun, Jiangxi, China
Actively Recruiting
Research Team
G
Guan Wei Jie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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