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 have been diagnosed by a specialist doctor with at least one of the following conditions: rheumatoid arthritis, systemic sclerosis (but only if a specific blood test called anticentromere antibody came back negative), inflammatory muscle disease (myositis), Sjögren's disease, or mixed connective tissue disease (but only if a specific blood test called anti-U1-RNP antibody came back positive)
• You have scarring/fibrotic lung disease confirmed by a detailed CT scan of the lungs, showing at least 10% of the lungs are affected, with the scan taken within the last 12 months
• Your lung function has not meaningfully improved with immune-suppressing treatments, based on breathing tests taken over the past 15 months
• Your doctor has not seen a significant improvement in your lung disease based on symptoms, scans, or other assessments
• Your lungs are still functioning at least at 45% of the expected normal level, as measured by a breathing test
• A specific measure of how well your lungs transfer oxygen into the blood is at least 25% of the expected normal level
• You have been on a stable dose of an immune-suppressing medication for at least 6 months (or at least 3 months if you have inflammatory muscle disease with lung involvement)
• If you take a steroid called prednisone, you have been on the same dose for at least 4 weeks before joining
• If you take a medication called rituximab, you finished your first course of treatment more than 6 months ago
• If you take a medication called nintedanib, you have been on a stable dose for at least 12 weeks
• Your doctor does not plan to change your current treatments during the trial
• Further eligibility requirements may also apply (confirm with trial site)

Who may not be able to join:

• Your CT scan shows a specific lung pattern called organising pneumonia as the main finding
• A particular breathing test result (FEV1/FVC ratio) is below 0.7, which may suggest a different type of airway problem
• You have had a sudden and serious worsening of your lung disease in the 3 months before joining or during the screening period
• You have active inflammation of your blood vessels (vasculitis) that is unstable or not well controlled within the past 8 weeks
• You have had any suicidal behaviour in the past 2 years
• You have had certain levels of suicidal thoughts (as measured by a standard scale) in the past 3 months or at the time of joining
• You have taken a medication called cyclophosphamide within the last 6 months, or a medication called pirfenidone within the last 8 weeks
• Further exclusion criteria may also apply (confirm with trial site)

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