Phase 3 Study to Evaluate Oral Belumosudil Added to Azithromycin for Adults With Chronic Lung Allograft Dysfunction After Bilateral Lung Transplant

What this Trial Is About

Researchers are evaluating the efficacy and safety of belumosudil compared with placebo in adult participants who have chronic lung allograft dysfunction CLAD after bilateral lung transplantation. This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants at least one year after their transplant, who show progressive CLAD despite treatment with azithromycin. The study is multinational, multicenter, and parallel-group, aiming to assess lung function changes over time. Participants will receive either 200 mg of oral belumosudil once daily or a matching placebo, both alongside azithromycin and standard immunosuppression care. The study includes a treatment period lasting up to 26 weeks for those not entering the open-label extension OLE and up to 52 weeks for those entering the OLE but not the long-term extension. For participants in the long-term OLE, treatment and study visits continue every 12 weeks as specified. During the study, participants will attend up to 10 visits if not entering the OLE, or up to 16 visits if entering the OLE but not the long-term phase. Assessments include lung function tests such as forced expiratory volume in 1 second FEV1 and forced vital capacity FVC, 6-minute walk distance, and quality of life questionnaires. Safety is monitored by recording adverse events. The total study duration may be up to 31 weeks for some and up to 57 weeks for others, with ongoing monitoring for those in the long-term extension.

A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction