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

Phase 3RecruitingNCT06082037

Sanofi180 enrolled

Overview

This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. Study details include: The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE. The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE. The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE. For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

180

Conditions

Lung Transplant Rejection

Interventions

BelumosudilDRUG

Tablet, Oral

AzithromycinDRUG

Depends on pharmaceutical presentation, Oral

PlaceboDRUG

Tablet, Oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant ≥1 year post bilateral lung transplantation at the time of screening * Participants presenting with CLAD Stage 1 or 2: FEV1 from \>50% to 80% of post-transplant baseline at screening and at randomization * Participants who have received at least 8 weeks of azithromycin (≥250 mg/day, at least 3 times a week) prior to randomization Exclusion Criteria: * FEV1 ≤50% of the post-transplant baseline value (CLAD 3 and 4) * Lung function decline that can be explained by non-CLAD causes including but not limited to acute lung allograft rejection (\>A1), antibody-mediated rejection, airway stenosis, or tracheobronchomalacia

Locations (80)

UAB Lung Health Center- Site Number : 8400026

Birmingham, Alabama, United States

RECRUITING

St. Joseph's Hospital & Medical Center - Norton Thoracic Research Department- Site Number : 8400019

Phoenix, Arizona, United States

RECRUITING

David Geffen School of Medicine at UCLA- Site Number : 8400020

Los Angeles, California, United States

RECRUITING

Stanford Health Care - Center for Advance Lung Disease- Site Number : 8400008

Stanford, California, United States