Phase 3 Interstitial Lung Disease Trial, Not Yet Recruiting

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

Who might be able to join this trial:

• People aged 40 or older, of any gender
• People who have been diagnosed with a lung condition called IPF (idiopathic pulmonary fibrosis), confirmed according to 2022 international medical guidelines, before or during the screening process
• People who have not taken either of the IPF medications nintedanib or pirfenidone for at least 8 weeks before screening, and who do not plan to start or restart either medication during the trial
• People who have been taking nintedanib or pirfenidone at a steady, unchanged dose for at least 12 weeks before screening — but not both medications at the same time
• People whose lungs are functioning at or above 45% of the expected capacity for their age and size, based on a breathing test called FVC (confirm with trial site)
• People whose lung capacity to transfer oxygen into the blood (measured by a test called DLCO) falls between 25% and 90% of the expected level, adjusted for their haemoglobin levels (confirm with trial site)
• People who are willing to take part and agree to sign a consent form

Who may not be able to join:

• People who have a significant blockage or obstruction in their airways, detected during a breathing test at screening
• People who have other significant lung conditions, as judged by the investigating doctor (minor conditions that need no treatment during the trial, such as small lung nodules or emphysema without symptoms, may be exceptions)
• People who have had a sudden severe worsening of their IPF in the 3 months before screening, or during the screening period
• People who are taking immune-suppressing medications (other than oral corticosteroids) for a lung condition, or who are taking prednisone or an equivalent steroid at a dose higher than 15 mg per day
• People who have a history of vasculitis (inflammation of the blood vessels)
• People who have made a suicide attempt or taken preparatory steps toward suicide at any point in the 2 years before screening
• People who have had active thoughts of suicide with a specific method or intent in the 3 months before or during screening, as assessed using a standard rating scale called the C-SSRS
• People who have had a respiratory infection needing antibiotics, or any other infection requiring treatment, within 4 weeks before or during screening
• People who have had major surgery in the 3 months before screening, or who have major surgery planned during the study (being listed for a lung transplant is not considered a reason for exclusion)
• People who have had cancer in the 5 years before screening — exceptions include certain treated skin cancers (basal cell carcinoma, squamous cell carcinoma in situ) and treated cervical carcinoma in situ
• People whose blood pressure is 160/100 mmHg or higher at screening
• People who have had an unstable or worsening heart or blood vessel condition in the 6 months before screening, such as a heart attack, unstable angina, heart failure, stroke, or blood clot
• People whose liver enzyme levels (AST or ALT) or bilirubin levels are significantly above the normal range in blood tests at screening (confirm with trial site for specific values)
• People whose kidneys are functioning at a low level, as measured by a blood test called eGFR, with a result of 30 or below (confirm with trial site)
• People who have had stomach or bowel surgery or a digestive condition that could affect how the body processes medication — except for appendix removal or hernia repair
• People who have active hepatitis B, hepatitis C, syphilis, or HIV infection, as detected by blood tests at screening
• People who have an existing liver disease that has caused measurable liver damage, as classified by a medical scoring system called Child-Pugh (confirm with trial site)
• People who have used recreational drugs, misused substances, or regularly consumed more than 2 standard alcoholic drinks per day in the 3 months before screening
• People who have used tobacco or nicotine products in the 3 months before screening, or who are unwilling to avoid them during the study
• People who have previously taken the study drug HSK44459, or who have taken certain other medications that work similarly (called PDE inhibitors, such as apremilast, roflumilast, or ibudilast) within 8 weeks before screening
• People who have taken certain medications known to strongly affect how the body breaks down drugs (strong CYP3A4 inhibitors or inducers) within approximately 2 weeks before the first dose, or who are expected to need them during the study (confirm with trial site)
• People who have a history of a severe allergic reaction to the study medication or any of its ingredients
• People who have taken part in another clinical trial involving an investigational drug or placebo within 1 month before screening
• People who are pregnant or breastfeeding, or people of childbearing potential — including male participants — who are unwilling to use contraception during the study and for 3 months afterward
• People whom the investigating doctor considers unsuitable for any other reason

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