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:

• You are willing and able to give your consent to take part in the study.
• You are 18 years of age or older.
• A recent chest scan (within the last 12 months) shows that more than 10% of your lungs are affected by scarring (fibrosis), as confirmed by a central review team.
• You have been diagnosed with a progressive scarring lung condition (other than IPF), and your condition has gotten worse within the last 24 months despite receiving standard treatment — this worsening may include a drop in lung function, worsening breathlessness, or increased scarring on chest scans.
• Your lung function (a measure called FVC) is at least 45% of what would be expected for someone your age and size, as confirmed by a central review team.
• You are either currently taking nintedanib or pirfenidone (and have been for at least 90 days, with plans to continue), or you have not taken either of these medicines for at least 90 days and do not plan to start them during the study — but you cannot be taking both at the same time.
• If you are taking immune-suppressing medicines (such as mycophenolate, methotrexate, azathioprine, steroids, or rituximab), you must have been on them for at least 120 days and your doctor believes they are not working well enough for you.
• If you are a woman who could become pregnant, you must not currently be pregnant or breastfeeding, and you must agree to either abstain from sex or use two reliable forms of contraception during the study and for at least 30 days after finishing the study drug.
• If you are a man whose partner could become pregnant, you must agree to use a condom throughout treatment and for at least 48 hours after finishing the study drug.
• In your doctor's opinion, you are able to communicate with the study team and are willing and able to follow the study requirements, including attending all required visits.

Who may not be able to join:

• You are currently pregnant or breastfeeding.
• Your breathing tests suggest a mainly obstructive airway problem (such as COPD-type obstruction), or your chest scan shows more emphysema (air trapping) than scarring.
• You have been diagnosed specifically with IPF (idiopathic pulmonary fibrosis).
• You have previously tried a type of medication called a prostacyclin or prostacyclin analogue and had to stop it or could not tolerate it properly.
• You have taken certain medicines used for pulmonary arterial hypertension (a type of high blood pressure in the lungs) within the last 60 days — including prostacyclins, endothelin receptor antagonists, PDE5 inhibitors (except occasional use for erectile dysfunction, with restrictions), or similar drugs (confirm with trial site for the full list).
• You need more than 10 litres per minute of supplemental oxygen while at rest.
• You have had a flare-up of your lung condition, or an active lung or upper respiratory infection, within the last 30 days — or you were hospitalised for one of these within the last 90 days.
• You have had a heart attack in the last 6 months, or unstable chest pain (angina) within the last 30 days.
• You have taken part in another clinical trial involving a medical treatment, procedure, or device within the last 30 days (observational or registry studies are generally fine).
• You have had a blood clot in your lungs (pulmonary embolism) within the last 90 days.
• In your doctor's opinion, you have another condition that could interfere with the study results or make it difficult for you to participate safely.
• In your doctor's opinion, your life expectancy is less than 12 months due to your lung condition or another serious illness.
• You have taken a medicine called nerandomilast within the last 60 days.

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