Randomized, double-blind, placebo-controlled, parallel group, Phase 3, followed by open-label extensions, to evaluate the efficacy of oral belumosudil in adult participants with chronic lung allograft dysfunction following bilateral lung transplantation

A randomized, double-blind, placebo-controlled, parallel group, Phase 3 study, followed by open-label extensions, to evaluate the efficacy of oral belumosudil in adult participants with chronic lung allograft dysfunction (CLAD) following bilateral lung transplantation.

Inova Fairfax Medical Center 
3300 Gallows Rd  
Falls Church, VA, 22042

1. Participant must be at least 18 years of age, at the time of signing the informed consent.
2. Participant ≥1 year post bilateral lung transplantation at the time of screening.
3. Participants presenting with CLAD Stage 1 or 2: FEV1 from >50% to 80% of PTBL at  screening and at randomization.
4. Participants who have received at least 8 weeks of azithromycin (≥250 mg/day, at least 3 times a week) following the diagnosis of CLAD and prior to randomization
5. Body mass index ≥18 kg/m2

1. ≤50% of the post-transplant baseline value (CLAD 3 and 4)
2. Participant who are enrolled in other clinical trials
3. Participants who are intolerant to belumosudil or any of its components
4. Known history of human immunodeficiency virus (HIV)
5. Participants who have received therapy for CLAD other than azithromycin and standard-of-care immunosuppressants. Participants who have received alemtuzumab, pirfenidone, nintedanib, thymoglobulin, basiliximab, JAK inhibitors, high dose steroid, total lymphoid irradiation (TLI) and ECP are excluded from the study. Previous use of montelukast, fluticasone, or mTORi is allowed if discontinued at least 28 days prior to 
   randomization. Previous induction therapy at the time of transplant (eg, thymoglobulin, alemtuzumab, or basiliximab) is allowed. High dose steroid as induction at the time of transplant and for the treatment of acute rejection if discontinued at least 8 weeks prior to screening are allowed.