Phase 3 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:

• Adults between 18 and 80 years old, of any gender.
• People who have been diagnosed with a connective tissue disease (a group of conditions affecting the body's connective tissues, such as lupus, Sjögren's syndrome, scleroderma, rheumatoid arthritis, or muscle inflammation conditions) AND also have scarring or inflammation of the lungs (interstitial lung disease), confirmed through symptoms, breathing tests, or a high-resolution CT scan of the chest.
• Alternatively, people who have confirmed lung scarring or inflammation (shown on a high-resolution chest CT scan or through a lung biopsy), where other known causes have been ruled out and a full connective tissue disease diagnosis cannot be made, but who show at least 2 out of 3 of the following groups of features: (1) certain physical signs such as cracked skin on the fingers, fingertip ulcers, joint stiffness lasting 60 minutes or more, small visible blood vessels on the hands, a condition where fingers change colour in the cold (Raynaud's phenomenon), unexplained finger swelling, or a specific skin rash on the knuckles; (2) certain blood test results showing specific antibodies or immune markers above set levels; or (3) specific patterns seen on chest CT scans, lung biopsies, or other unexplained chest findings such as fluid around the lungs or heart, airway problems, or blood vessel disease in the lungs (confirm with trial site).

Who may not be able to join:

• People whose liver enzyme levels (AST and ALT) are above 1.5 times the normal upper limit at the first study visit.
• People whose bilirubin (a liver-related substance in the blood) is above 1.5 times the normal upper limit at the first study visit.
• People whose kidneys are not filtering well enough, with a calculated clearance rate below 30 mL/min at the first study visit.
• People who have an existing chronic liver disease of any severity.
• People who have taken another experimental medication within 1 month, or within 6 half-lives of that medication (whichever period is longer), before the screening visit.
• People with significant high blood pressure in the arteries of the lungs (pulmonary arterial hypertension), including those with evidence of serious right-sided heart failure, a very low heart output shown on a heart catheter test, or those who need ongoing intravenous medication to manage the condition.
• People with other lung problems considered clinically significant by the study doctors.
• People with major physical limitations outside the lungs, such as chest wall deformities or a large amount of fluid around the lungs.
• People with serious heart or blood pressure problems in the 6 months before the first visit, including uncontrolled high blood pressure (at or above 160/100 mmHg despite treatment), a heart attack, or unstable chest pain.
• People with a history of serious events affecting the brain or nervous system.
• People with a known allergy to the experimental drug being studied.
• People with other medical conditions that the study doctors believe could interfere with the trial or put the person at risk.
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial.
• People who are unable to understand or follow the trial procedures, including completing questionnaires independently without assistance.

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