Kirchheim Unter Teck

This research aims to evaluate how the medicine nerandomilast affects lung fibrosis in adults with systemic autoimmune rheumatic diseases who have lung fibrosis. The study includes adults 18 years and older who have not shown improvement in lung function after standard immunosuppressant treatment. Participants have interstitial lung disease related to rheumatic diseases such as rheumatoid arthritis, systemic sclerosis, idiopathic inflammatory myopathy, Sjgrens disease, or mixed connective tissue disease. Participants are randomly divided into two groups one group receives nerandomilast tablets and the other receives placebo tablets that look identical but contain no medicine. Tablets are taken twice daily for at least 26 weeks and up to 1 year. Participants continue their usual immunosuppressant treatments during the study. Participants stay in the study for about 7.5 to 13 months and visit the study site 9 to 10 times. During visits, lung function tests and chest imaging are performed, and participants complete questionnaires about symptoms and quality of life. Researchers compare results between the groups to assess the effects of nerandomilast while monitoring health and any side effects throughout the study.

Eosinophilic granulomatosis with polyangiitis EGPA is a rare immune disorder causing asthma, high levels of eosinophils in the blood, and inflammation of blood vessels, affecting organs like skin, lungs, nerves, and kidneys. This research aims to find new biological markers, or biomarkers, to better assess how active the disease is in people with EGPA, improving disease monitoring and future treatment development. The study involves regular visits every 6 or 12 months where participants provide blood and urine samples. Each visit includes a physical exam, medical and medication history review, and completion of questionnaires about disease activity, health status, and lifestyle habits. These procedures help researchers identify biomarkers that reflect disease severity and response to treatment. Participants will be monitored over time with repeated assessments to track disease progression and biomarker levels. Researchers will analyze these data to discover markers that can predict clinical outcomes and guide care. The study aims to improve understanding of EGPA activity and support better management for patients during times when symptoms may not be obvious.