Evaluating Nerandomilast for Safety and Benefits in Children and Teens Aged 2 to 17 with Fibrosing Interstitial Lung Disease

What this Trial Is About

Researchers are investigating nerandomilast in children and adolescents aged 2 to 17 years who have fibrosing interstitial lung disease ILD. Nerandomilast has already been approved for adults with idiopathic pulmonary fibrosis, and this study aims to understand how the drug is tolerated, processed by the body, and whether it may help younger patients with ILD. The study includes both younger children and older childrenadolescents in different treatment groups to assess these questions. Participants aged 6 to 17 years are randomly placed into one of two groups one receiving nerandomilast and the other a placebo, with twice as many participants receiving nerandomilast. They take tablets twice daily for six months, then all receive nerandomilast for at least two years. Children aged 2 to 5 years receive nerandomilast from the start for at least two and a half years. The total study duration varies between two and a half and five years depending on when participants join. During the study, participants may visit the study site about 18 to 30 times. Doctors collect blood samples to monitor health and drug processing, assess lung function, growth, and quality of life, and track any changes in health. For those aged 6 to 17 years, comparisons between the nerandomilast and placebo groups help evaluate potential treatment effects. Safety and treatment-related side effects are closely monitored throughout the study period.

A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)