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

Recruiting Phase 3 Interventional Study
Lung Transplant Rejection
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
180 (estimated)
Sponsor
Sanofi · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
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 azithrom…
Contacts

Trial Transparency email recommended (Toll free number for US & Canada)

800-633-1610

contact-us@sanofi.com

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