Nerandomilast for Interstitial Lung Disease

This trial tests nerandomilast, a potential new treatment for individuals with interstitial lung disease (ILD) related to autoimmune diseases such as rheumatoid arthritis or systemic sclerosis. The researchers aim to determine if nerandomilast can improve lung function in those unresponsive to standard immunosuppressant treatments. Participants will receive either nerandomilast or a placebo (a pill with no active medicine) for up to a year. Suitable candidates have a fibrotic lung condition visible on scans and have not experienced improvement in breathing tests or symptoms despite current treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for ILD.

The trial does not require you to stop taking your current medications. In fact, participants must continue their immunosuppressant treatment for their underlying rheumatic disease and be on stable doses of certain medications for a specified period before joining the trial.

Research has shown that nerandomilast is generally well-tolerated by people with lung diseases. In earlier studies, participants experienced manageable side effects, meaning any negative effects were not too severe and could be easily handled. One study found no increase in serious problems or treatment discontinuations compared to other patients.

Nerandomilast is unique because it targets interstitial lung disease with a novel mechanism of action. Unlike traditional treatments such as corticosteroids or immunosuppressants, which generally aim to reduce inflammation, Nerandomilast specifically inhibits certain pathways responsible for lung tissue scarring. This targeted approach could potentially slow or even halt the progression of lung damage more effectively. Researchers are excited about Nerandomilast because it offers hope for improved outcomes and quality of life for patients with this challenging condition.

Research has shown that nerandomilast, which participants in this trial may receive, can slow the decline in lung function for people with progressive pulmonary fibrosis. One study found that patients taking nerandomilast experienced a smaller decrease in lung capacity, measured by forced vital capacity (FVC), compared to those on a placebo over a year. Additionally, combined data suggests that nerandomilast may reduce the risk of death in patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. These findings indicate that nerandomilast could be beneficial for lung conditions related to systemic autoimmune diseases.²³⁶⁷⁸