Gommern

This trial studies adults aged 18 years and older with lung fibrosis caused by systemic autoimmune rheumatic diseases who have not shown lung function improvement after standard immunosuppressant treatment. It evaluates how the medicine nerandomilast affects lung disease associated with these conditions. The study is a phase 3, double-blind, randomized, placebo-controlled trial designed to test nerandomilast's safety and efficacy over at least 26 weeks. Participants are randomly assigned to receive either nerandomilast tablets or placebo tablets twice daily for a period of at least 26 weeks and up to 1 year. Alongside this, participants continue their ongoing immunosuppressant treatments for their rheumatic disease. The study involves two groups receiving either the active drug or placebo to compare outcomes between them. During the 7.5 to 13 months of participation, individuals visit the study site about 9 to 10 times for lung function tests, chest imaging at select visits, and to complete questionnaires about symptoms and quality of life. Researchers monitor changes in lung disease using high-resolution CT scans and assess safety by recording any side effects. The main outcome is the change in lung fibrosis score after 26 weeks of treatment.