A double blind, randomised, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over 26 weeks in patients with Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD)

A tablet called nerandomilast is being tested in a 26-week trial to see if it can improve lung function in people with lung scarring linked to autoimmune diseases like rheumatoid arthritis or scleroderma. Many patients with these conditions develop interstitial lung disease (ILD) — scarring that stiffens the lungs and makes breathing progressively harder. Standard immunosuppressant drugs often fail to stop this decline. The trial enrols only adults whose lung function has not improved after such treatment, targeting a group with few remaining options. Participants are randomly assigned to receive either nerandomilast or a placebo twice daily, while continuing their usual immunosuppressants. Lung function tests, chest imaging, and symptom questionnaires track outcomes over roughly seven and a half months. If nerandomilast proves effective, it would offer a new treatment pathway for a condition that currently has limited pharmacological options beyond immunosuppression. The drug belongs to a class that targets fibrosis directly, rather than the underlying immune inflammation. Success could slow or halt lung scarring in thousands of patients with autoimmune-related ILD, preserving breathing capacity and quality of life. The trial also generates safety data essential for regulatory approval and clinical adoption.