Phase 2 Interstitial Lung Disease Trial, 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 who have been diagnosed with progressive fibrotic interstitial lung disease (a type of scarring lung condition) or progressive idiopathic pulmonary fibrosis (IPF), diagnosed using recognised international medical guidelines
• People who are older than 18 years of age
• People who have had a specific type of detailed lung scan (called an HRCT) within the past 24 months
• People whose lungs are working at more than 45% of normal breathing capacity, with a breathing test result showing airways are not significantly obstructed (confirm with trial site)
• People whose lung capacity has declined by at least 5% over the year before joining, based on at least three breathing tests taken within the 6 to 24 months before enrolment
• People who are able to understand the study and give their consent to take part
• People whose most recent lung scan shows more scarring than emphysema (a different type of lung damage)
• Male participants of reproductive potential who agree to use highly effective contraception from the first dose until 90 days after the last dose of the trial medication
• Female participants who agree to use highly effective contraception during the study and who have a negative pregnancy test before joining
• People who are able to walk at least 150 metres during a standard 6-minute walk test at the first screening visit
• People who are able to read and complete three health questionnaires (EQ-5D, SGRQ-I, and K-BILD)

Who may not be able to join:

• People who have sickle cell disease
• People who have any medical condition or circumstance that, in the investigator's opinion, makes participation unsuitable or unlikely to be completed safely
• People who have a known allergy to any ingredient in the trial medication, or a history of a significant allergic reaction to any medication
• People who currently have a condition that suppresses the immune system
• People who have clinically significant abnormalities in heart rhythm or electrical conduction detected on a heart tracing (ECG)
• People with moderate to severe liver disease, or abnormal liver function test results at screening
• People with laboratory results suggesting a bile flow problem, with bile acid levels more than three times the upper limit of normal
• People with abnormal kidney function, as defined by a specific kidney filtration measurement (confirm with trial site for exact threshold)
• People who have had a cancer diagnosis within the past 5 years
• People who have taken part in another clinical trial using an investigational medication for a fibrotic disease within the last 6 months
• People who are currently taking part in another interventional research study, or who have used an investigational treatment within a defined period before joining (confirm with trial site)
• People who have had a lower respiratory tract infection requiring treatment within 4 weeks before screening, or during the screening period
• People who have previously had lung volume reduction surgery or a lung transplant
• People who have been diagnosed with severe pulmonary hypertension (high blood pressure in the lungs)
• People who have had an unstable heart, lung (other than IPF), or other serious health condition within 6 months before screening or during the screening period
• People who are using, or plan to use, certain specific medications during the study — including warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil (except occasional use), or prednisone at a steady dose above 10 mg per day (or an equivalent steroid) — within 4 weeks before or during screening
• People with current alcohol or substance misuse, in the opinion of the investigator

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