Actively Recruiting
Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter 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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of HSK31858, a novel DPP1 inhibitor, in adults with non-cystic fibrosis bronchiectasis (NCFBE). This phase III, randomized, double-blind, placebo-controlled, multicenter study aims to reduce pulmonary exacerbations in participants who have experienced at least two exacerbations in the past year. The study is sponsored by Haisco Pharmaceutical Group Co., Ltd. and focuses on a population with confirmed bronchiectasis affecting one or more lung lobes, excluding those with cystic fibrosis or certain other lung diseases. Participants will be randomly assigned to receive either HSK31858 40 mg tablets or a placebo for 52 weeks. The treatment is administered orally once daily. The study includes a placebo comparator group to evaluate the effects of HSK31858 against no active treatment. The trial also requires stable dosing of any long-term bronchodilator therapies during the study period. During the 52-week study, participants will be monitored regularly for pulmonary exacerbations and lung function changes using measures such as forced expiratory volume in 1 second (FEV1), sputum weight, sputum purulence, and quality of life assessments specific to bronchiectasis symptoms. Safety will be assessed throughout the trial, and participants will be followed closely to evaluate treatment outcomes and adverse effects. Total participation duration is approximately one year, including screening and treatment.
CONDITIONS
Brief 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 and BMI of at least 18.0 kg/m² at the time of consent
- Chest HRCT showing bronchiectasis affecting one or more lobes confirmed as non-cystic fibrosis bronchiectasis
- At least 2 pulmonary exacerbations in the past 12 months before screening
- Stable long-term bronchodilator treatment (if used) for at least 3 months before screening and during the study
- Estimated survival time of at least 12 months
- Women must be post-menopausal, surgically sterile, or using highly 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 to participate
You will not qualify if you...
- Primary diagnosis of COPD or asthma
- History of malignancy within 5 years prior to screening (with some exceptions) or history of antitumor therapy
- Bronchiectasis due to cystic fibrosis
- Current treatment for Non-tuberculous Mycobacterial pulmonary infections, allergic bronchopulmonary aspergillosis, tuberculosis, or active COVID-19
- Severe pulmonary fibrosis, lung destruction, pneumonectomy, pneumoconiosis, or decompensated pulmonary heart disease
- Acute exacerbation of bronchiectasis within 4 weeks before screening
- Hemoptysis requiring medical intervention within 4 weeks prior to screening (except minor bloody streaks)
- Previous treatment with HSK31858 or other DPP1 inhibitors
- Uncontrolled hypertension or diabetes
- History or current treatment of significant liver disease
- Active hepatitis B or C, HIV, or syphilis infection
- Other unstable clinical conditions affecting safety or study results
- Abnormal laboratory test results during screening beyond set thresholds
- Participation in another clinical trial within 3 months prior to screening
- Use of medications causing hyperkeratosis within 4 weeks prior to screening
- Use of strong CYP3A inducers or suppressors near study start
- Smoking 10 or more cigarettes daily in the past year
- Pregnancy or lactation
- Inability to complete questionnaires or log cards due to educational or other limitations
- Recent live attenuated vaccine within 30 days before randomization
- Any other conditions judged unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive either HSK31858 or placebo tablets to assess the efficacy and safety of the drug over time.
Regular visits throughout the 52-week treatment period
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
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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