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Testing the effectiveness of belumosudil for treating lung transplant rejection

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

PHASE3 · Sanofi · NCT06082037

This study is testing if belumosudil can help improve lung function in adults who have had a lung transplant and are experiencing ongoing issues with their new lungs.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi (industry)
Locations79 sites (Birmingham, Alabama and 78 other locations)
Trial IDNCT06082037 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial is a double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of belumosudil tablets in adult participants with chronic lung allograft dysfunction (CLAD) who are at least one year post bilateral lung transplant. Participants will receive either belumosudil or a placebo, alongside azithromycin and standard immunosuppressive therapy. The study will last up to 31 weeks for those not entering the open-label extension period, with multiple visits scheduled throughout the trial. The goal is to determine if belumosudil can improve lung function in patients experiencing progressive CLAD despite existing treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are at least one year post bilateral lung transplantation and have evidence of progressive CLAD despite azithromycin therapy.

Not a fit: Patients with severe lung function decline (FEV1 ≤50% of post-transplant baseline) or those whose lung function issues are due to non-CLAD causes will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients suffering from chronic lung allograft dysfunction.

How similar studies have performed: While this approach is novel in the context of CLAD treatment, similar studies have shown promise in evaluating new therapies for lung transplant rejection.

Eligibility criteria

Show full inclusion / exclusion 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 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where this trial is running

Birmingham, Alabama and 78 other locations

+29 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Lung Transplant Rejection

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.