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:

• People whose lung disease (ILD) linked to a connective tissue disorder has not improved enough, has stayed unstable, or has gotten worse despite standard treatment — or who could not tolerate standard treatment
• People who have been formally diagnosed with one of the following conditions: rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), an inflammatory muscle disease (such as polymyositis, dermatomyositis, or anti-synthetase syndrome), Sjögren's syndrome, or mixed connective tissue disease (MCTD), based on recognised medical classification standards
• People whose lung scans (a type of detailed CT scan) show inflammatory and/or scarring lung disease covering at least 10% of the lungs
• People with signs that their lung disease is ongoing or getting worse
• People who are currently on stable standard treatment for their lung disease and/or connective tissue condition, or who have been unable to take or continue standard treatment
• People who are able and willing to self-administer the study medication, or who have a carer who is able and willing to do so throughout the study
• Women who are not pregnant and not breastfeeding, and who are either unable to become pregnant, or who are using a highly effective form of contraception (with a failure rate of less than 1%)
• People who are able to give their signed agreement to take part in the trial

Who may not be able to join:

• People whose lung disease (ILD) is caused by something other than a connective tissue disorder
• People whose primary diagnosis is systemic sclerosis (also known as scleroderma)
• People whose disease has been rapidly getting worse — specifically, those whose lung function has dropped significantly between the screening visit and the baseline visit, or who have recently been hospitalised due to lung problems
• People whose lung function test results fall below certain thresholds at screening (confirm with trial site for exact values)
• People who have a history of, or currently have, bleeding in the lungs (diffuse alveolar hemorrhage) or other significant lung conditions that could interfere with the study
• People who require treatment for high blood pressure in the lung arteries (pulmonary arterial hypertension)
• People who rely on continuous oxygen supplementation
• People with significant heart, breathing, liver, kidney, digestive, hormonal, blood, or neurological conditions that could affect how the study drug works in the body, pose a risk during the study, or make it harder to interpret results
• People whose lung function tests show an obstructive breathing pattern (confirm with trial site for exact values)
• People whose lung scans show significant emphysema that is more extensive than the ILD
• People who have a confirmed diagnosis of a serious brain infection called progressive multifocal leukoencephalopathy (PML), or who have unexplained new or worsening neurological symptoms
• People who score 10 or above on a standard mental health questionnaire (PHQ-9) and are assessed by a mental health professional as posing a serious suicide risk, or who have had suicidal behaviour in the last 6 months, or suicidal thoughts in the last 2 months, or who the trial investigator considers to be at significant suicide risk
• People who have had lymphoma, leukaemia, or most other cancers within the past 5 years (some skin cancers that were fully removed with no spread for at least 3 years may be considered — confirm with trial site)
• People who have had breast cancer within the past 10 years
• People who have had major surgery (including joint surgery) within the 3 months before screening, or who have major surgery planned during the study
• People who have an active infection or a relevant history of infections (confirm with trial site for specific details)

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