Phase 3 Cystic Fibrosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older and have a healthy body weight (BMI of 18.0 or above)
• A detailed lung scan (HRCT) has confirmed that you have bronchiectasis (a condition causing widened, damaged airways) affecting one or more areas of your lungs, with symptoms such as long-term cough, mucus production, and/or occasional coughing up of blood
• You have had at least 2 lung flare-ups (periods when your symptoms got significantly worse) in the past 12 months
• If you regularly take long-acting inhalers, your dose and routine have stayed the same for at least 3 months before joining and must remain the same throughout the study
• Your doctors expect you to live for at least 12 more months
• Women must be past menopause, have had surgery to prevent pregnancy, or agree to use reliable contraception from the first dose until at least 30 days after the last dose
• Men whose partners could become pregnant must agree to use reliable contraception from the first dose until at least 90 days after the last dose
• You are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

• You have been diagnosed with COPD or asthma as your main lung condition
• You have had cancer in the past 5 years or have received cancer treatment (some exceptions may apply — confirm with trial site)
• Your bronchiectasis is caused by cystic fibrosis (CF)
• You are currently being treated for certain lung infections, including non-tuberculous mycobacteria (NTM), tuberculosis (TB), or a fungal condition called allergic bronchopulmonary aspergillosis, or you have an active COVID-19 infection, or have a history of bronchopulmonary aspergillosis
• You have severe scarring or destruction of the lung tissue, have had a lung removed, have a dust-related lung disease (pneumoconiosis), or have had severe heart strain caused by lung disease
• You had a bronchiectasis flare-up within the 4 weeks before screening
• You coughed up a significant amount of blood (more than minor streaks) and needed medical treatment within the 4 weeks before screening
• You have previously taken HSK31858 or any other DPP1 inhibitor medication
• You have very high blood pressure that is not controlled (resting reading of 180/110 or higher)
• You have uncontrolled diabetes with a fasting blood sugar above 7.0 mmol/L
• You have a significant liver condition (such as hepatitis, cirrhosis, or liver failure), with the exception of mild to moderate non-alcoholic fatty liver disease
• You have an active hepatitis B or hepatitis C infection, or a known HIV or syphilis infection
• You have any other serious ongoing health condition that the trial doctors believe could affect your safety, the study results, or your ability to complete the study
• Certain blood test results from screening fall outside acceptable ranges, including abnormal liver markers, reduced kidney function, low red blood cells (anaemia), low white blood cells, low platelets, or abnormal blood clotting results (confirm with trial site for specific values)
• You have taken part in another clinical drug or medical device trial within the past 3 months, or the previous trial drug has not fully left your system
• You have taken certain medications that can cause skin thickening (such as some immune-system drugs called TNF-α antagonists) within the 4 weeks before screening
• You have taken certain medications that strongly affect how the body processes drugs (strong CYP3A inducers or suppressors) within 14 days or 5 half-lives before your first dose, whichever is longer
• You have smoked an average of 10 or more cigarettes per day over the past year
• You are pregnant or breastfeeding
• You are unable to complete questionnaires or fill in study diary cards due to literacy or other difficulties
• You have received a live vaccine within 30 days before being randomly assigned to a treatment group
• The trial doctors have identified any other reason they feel makes participation unsuitable for you

Important: Always verify eligibility with the trial site directly before applying.