Phase 2 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 aged 40 years or older, of any gender
• People who have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) — a type of lung scarring disease — confirmed using recognised international medical guidelines
• People whose lung scans (taken within 2 months of the study start date) or past lung biopsy show a specific pattern of scarring called UIP (usual interstitial pneumonia) or probable UIP
• People already taking one of the IPF medications pirfenidone or nintedanib, as long as the dose has been stable for at least 2 months before the study start date and there are plans to keep it stable throughout the study (taking both medications together is not allowed)
• People not currently taking pirfenidone or nintedanib, as long as neither has been taken for at least 4 weeks before the study start date, with no plans to start either during the study
• People taking a single medication for pulmonary hypertension (high blood pressure in the lungs), as long as the dose has been stable for at least 4 weeks before the study start date and there are plans to keep it stable throughout the study
• People whose lungs are still functioning at or above 40% of the expected normal level for breathing capacity (measured by a lung function test called FVC)
• People whose lungs are functioning between 25% and just below 80% of the expected normal level for transferring oxygen into the blood (measured by a test called DLCO)

Who may not be able to join:

• People with significant airway blockage, based on a specific breathing test result (confirm with trial site)
• People with other significant lung conditions, as determined by the trial investigator
• People with severe pulmonary arterial hypertension (PAH), including those with serious right-heart problems, poor heart output shown by a heart catheter test, or those who need multiple PAH medications or PAH medications given through a vein
• People whose lung scans show emphysema (air sac damage) covering 50% or more of the lungs, or where the emphysema appears more extensive than the scarring
• People who have had a sudden worsening (acute exacerbation) of their IPF in the 6 weeks before screening or during the screening period
• People whose lung scarring is caused by another known condition
• People who have had a lower respiratory tract infection requiring antibiotics in the 4 weeks before the study start date or during the screening period
• People who have had major surgery in the 6 weeks before the study start date, or who have major surgery planned during the trial (being on a transplant waiting list is allowed)
• People with certain abnormal liver, kidney, or blood test results that fall outside acceptable ranges (confirm with trial site)
• People with a chronic liver disease of any severity
• People with severe uncontrolled high blood pressure (at or above 160/100 mmHg despite treatment)
• People who have had a heart attack within 6 months of the study start date
• People with unstable chest pain caused by the heart (unstable angina)
• People with a known hereditary tendency to bleed
• People who require strong blood-thinning medications (full-dose anticoagulants) or high-dose anti-platelet medications above specified thresholds (confirm with trial site for exact thresholds; low-dose preventive use of some of these medications may be permitted)
• People who have had bleeding in the brain within 12 months of the study start date
• People who have had coughing up blood or blood in the urine within 3 months of the study start date
• People who have had active gastrointestinal bleeding requiring hospital treatment or a peptic ulcer within 3 months of the study start date
• People with certain abnormal blood-clotting test results (confirm with trial site)
• People who have had a blood clot, stroke, or mini-stroke (transient ischaemic attack) within 12 months of the study start date
• People who have used certain immune-system-modifying medications (including some arthritis drugs or drugs that reduce immune cell activity) within 6 months of the study start date
• People who have been taking high-dose steroid medications (equivalent to more than 15 mg per day of prednisone) within 2 weeks of the study start date
• People taking both pirfenidone and nintedanib at the same time during screening
• People with another condition that, in the investigator's judgement, could interfere with the trial or put them at risk
• People with any active or suspected cancer diagnosed within the past 5 years, with the exception of certain treated skin cancers or prostate cancer that is being monitored
• People with signs of an active infection (either ongoing or recent), based on examination or test results
• People who have had a confirmed COVID-19 infection within 4 weeks of the study start date or during the screening period
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
• Women who are capable of becoming pregnant and are not willing or able to use highly effective contraception for 28 days before and 3 months after receiving the study medication
• People who, in the investigator's opinion, have active alcohol or drug misuse problems
• People who are not able to understand or follow the trial procedures, including completing questionnaires independently

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