Kirchheim Unter Teck

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.

Eosinophilic granulomatosis with polyangiitis (EGPA), also known as allergic granulomatosis angiitis or Churg-Strauss Syndrome, is a rare immune disorder causing asthma, high eosinophil levels, and inflammation of blood vessels affecting various organs. This research aims to find new biological markers called biomarkers that can measure disease activity and help assess how severe EGPA is in patients. Identifying these biomarkers could improve how doctors monitor the disease and guide future treatments. Participants in the study will have visits every six months or once a year. During these visits, blood and urine samples will be collected to analyze potential biomarkers. Each visit also includes a physical exam, medical and medication history review, and completion of several questionnaires that evaluate disease activity, overall health, and lifestyle factors such as tobacco, alcohol, and drug use. Throughout the study, researchers will track how these biomarkers relate to disease activity and response to treatment. The goal is to better understand EGPA progression and support the development of improved care. The total duration and number of visits depend on the participant's involvement over time, with ongoing monitoring to capture changes in disease status.

Researchers are evaluating the safety and effectiveness of NS-229 compared to a placebo in adults aged 18 years or older who have Eosinophilic Granulomatosis With Polyangiitis (EGPA), also known as Churg-Strauss Syndrome. This is a Phase 2, randomized, double-blind study involving participants who are receiving corticosteroid therapy, with or without Mepolizumab or Benralizumab treatment. The study aims to measure clinical remission, defined by a specific vasculitis activity score and a low corticosteroid dose. Participants will be randomly assigned to receive either NS-229 or a placebo over a 28-week treatment period. During this time, their corticosteroid doses will be gradually reduced. The study compares the effects of the investigational drug NS-229 against placebo while participants continue their background treatments. Throughout the study, researchers will monitor remission rates using clinical scores and corticosteroid dosing. Participants will undergo assessments to evaluate disease activity and safety over the 28 weeks. The main outcome measured is the proportion of subjects who achieve remission by the end of the treatment period.