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 are 40 years of age or older at the time of signing the consent form
• People who have been diagnosed with IPF (idiopathic pulmonary fibrosis) according to internationally recognised 2022 guidelines
• People whose IPF diagnosis was made no more than 7 years ago
• People who have never previously taken the medications pirfenidone or LYT-100 (even a single dose)
• People whose recent lung scan (within the last 12 months) shows a specific pattern of scarring called UIP, confirmed by a central reviewing team
• People whose lung capacity measurement (a breathing test called FVC) is at least 45% of what would be expected for a healthy person of the same age and size

Who may not be able to join:

• People whose IPF has significantly worsened between the first and second trial visits, in the opinion of the investigating doctor (for example, a serious hospital stay or a significant breathing event)
• People who were hospitalised in the 3 months before the first trial visit due to a sudden worsening of IPF or another serious breathing complication
• People whose breathing test results at the first visit show a certain airflow pattern that suggests a different lung condition (confirm with trial site)
• People whose most recent lung scan shows more emphysema (air trapping damage) than scarring, as confirmed by the central reviewing team
• People who have another condition that could itself explain their interstitial lung disease
• People who have a serious condition outside the lungs that could affect their breathing test results
• People who currently have another significant lung or breathing disorder
• People who have significant high blood pressure in the arteries of the lungs (pulmonary hypertension)
• People who have previously had a lung transplant
• People who have cardiovascular (heart and blood vessel) disease
• People who have long-term liver disease or liver problems
• People who have certain active or poorly controlled infections, including active hepatitis B or C, or poorly controlled HIV
• People who have had a major operation in the 6 weeks before the first trial visit, or who are planning a major operation during the study period
• People who have an active cancer, a suspected cancer, or a history of cancer within the past 5 years
• People whose blood test results at the first visit show certain liver or kidney markers outside acceptable ranges (confirm specific values with trial site)
• People who are currently taking the steroid medication prednisone (or an equivalent) at a regular dose of more than 10 mg per day
• People who have used any tobacco products or combustible cannabis products in the 3 months before the first trial visit, or who are unable to stop using them during the study
• People who have known swallowing difficulties, trouble swallowing capsules or tablets, or who have had their entire stomach surgically removed
• People who are currently taking part in another clinical trial involving an experimental drug or device, or who have used an investigational drug or device in the 90 days before the first trial visit (observational studies and registries may be acceptable — confirm with trial site)
• People who have ever received stem cell therapy for pulmonary fibrosis
• People who are currently pregnant, breastfeeding, or planning to become pregnant during the study
• People who have ever taken pirfenidone or LYT-100 at any time, even once

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