Phase 3 Interstitial Lung Disease 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:

• People who have been diagnosed with idiopathic pulmonary fibrosis (IPF — a condition that causes scarring in the lungs), confirmed using a specialised chest scan (high-resolution CT) taken within the past 12 months, and where an independent panel of imaging experts has also reviewed and agreed with the diagnosis before the trial begins.
• People who are willing to take part and who have signed a consent form before any study activities begin.
• People who are between 40 and 80 years of age (inclusive) at the time of signing the consent form, of any sex.
• People who are capable of having children and who agree to use highly effective contraception from the time of signing the consent form until 90 days after the last dose of the study medicine.
• People whose IPF has been stable for at least 8 weeks before the first visit, and who either: have not taken the IPF medicines nintedanib or pirfenidone for at least 8 weeks before the first visit (including those who were never on these medicines, or those for whom these medicines did not work); or have been on a stable, unchanged dose of nintedanib or pirfenidone for at least 12 weeks before the first visit and plan to continue this medicine throughout the trial.
• People whose breathing test results at screening and at the baseline visit show a specific ratio of airflow (FEV1/FVC) of 0.70 or above.
• People whose lungs are functioning at more than 50% of the expected normal capacity for their age and size, based on a breathing test (FVC), at both screening and the baseline visit.
• People whose lungs' ability to transfer oxygen into the blood (measured by a test called DLco) is at 30% or more of the expected normal value, at both screening and the baseline visit.
• People who had an active infection requiring treatment in the 4 weeks before screening, but where the treating doctor has determined the infection was fully cleared during the screening period (confirm with trial site).
• People who the trial doctor believes are willing and able to follow the study requirements and attend all scheduled visits.

Who may not be able to join:

• People whose lung disease is caused by something other than IPF, such as exposure to substances at home or work, a connective tissue disease, or certain medicines.
• People who have other significant lung conditions in addition to IPF, such as asthma, chronic obstructive pulmonary disease (COPD), or significant airflow obstruction, hypersensitivity pneumonitis, or eosinophilic pneumonia.
• People who are planning to have a lung transplant within 12 months of the screening visit.
• People who have had active tuberculosis in the 12 months before screening, or who have any active infection requiring treatment during the screening period.
• People whose IPF the trial doctor considers to be unstable at screening, or who have had a sudden worsening of their IPF in the 8 weeks before or during the screening period.
• People who have, in the 4 weeks before being assigned to a treatment group, taken: certain IPF medicines at unstable doses, or steroid medicines at more than 15 mg per day of prednisone or equivalent, or immune-modifying medicines for lung reasons; or certain strong medicines that affect how the liver breaks down other drugs (called strong CYP3A4 inhibitors, such as ritonavir or clarithromycin); or certain medicines that are affected by specific liver enzymes or transporters (such as warfarin, digoxin, or phenytoin); or a medicine called belumosudil (a ROCK2 inhibitor).
• People who have had a cancer diagnosis in the 5 years before screening, with the exception of certain treated skin cancers or treated cervical cancer in situ.
• People with moderate to severe liver disease (classified as Child-Pugh Class B or C).
• People whose blood test results at screening or the baseline visit show certain liver enzyme or muscle enzyme levels above the acceptable thresholds set by the trial.
• People with uncontrolled hepatitis B or hepatitis C virus infection at screening.
• People who have had an unstable or worsening heart condition in the 6 months before screening, including unstable chest pain (angina), a heart attack, heart failure requiring hospitalisation, or severe uncontrolled irregular heartbeat.
• People with a family history of a heart rhythm condition called long QT syndrome or sudden death, or whose heart tracing (ECG) at screening or baseline shows certain abnormal results, including a prolonged QTc interval, atrial fibrillation or flutter, certain types of heart block, or left bundle branch block.
• People whose blood pressure at screening and baseline remains above 160/100 mmHg after resting for at least 5 minutes, confirmed by a repeat measurement.
• People who were hospitalised for a stroke or bleeding in the brain in the 12 months before screening.
• People whose kidneys are not filtering blood well enough, based on a calculated measure of kidney function (creatinine clearance below 50 mL/min).
• People who are unable to complete a six-minute walk test or standard breathing (lung function) tests.
• People who have smoked in the 3 months before screening, or who are unwilling to stop smoking during the study.
• People who regularly drink more than 21 units of alcohol per week (where 1 unit equals approximately 360 mL of beer, 45 mL of spirits, or 150 mL of wine) in the 6 months before screening, or who are unwilling to keep alcohol intake within this limit during the study.
• People who have misused drugs or substances in the 6 months before screening.
• People who are pregnant or breastfeeding.
• People whose HIV test result is not negative at screening.
• People who are known to be allergic to any ingredient in the study medicine (TDI01 suspension).
• People who received their last dose of medicine in another clinical trial within 3 months or within 5 half-lives of that medicine before screening, whichever period is longer.
• People who have had major surgery under general anaesthesia in the 3 months before screening, or who have surgery planned during the study that the trial doctor believes could affect the study results.
• People who the trial doctor considers to have another unstable health condition that could affect their safety, their ability to follow the study requirements, how the study medicine is absorbed, or their ability to complete all study assessments.

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