NCT05922761

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research study is to test the efficacy of a novel immunosuppressive agent, belumosudil, in allogeneic hematopoietic stem cell transplant (HSCT) recipients who have been newly diagnosed or have developing (early stage) bronchiolitis obliterans syndrome (BOS). The name of the study drugs involved in this study are: * Belumosudil (an immunotherapy) * Fluticasone (an intranasal corticosteroid) * Azithromycin (an antibiotic) * Montelukast (a leukotriene receptor antagonist) * Prednisone (a corticosteroid)

Detailed description

This is an open-label, single-arm, single-stage phase 2 study to evaluate the activity of Belumosudil in subjects with new onset of bronchiolitis obliterans syndrome (BOS) (Cohort A) and for subjects with incipient BOS (Cohort B) following allogeneic hematopoietic cell transplantation (HCT). Belumosudil is a novel immunosuppressive agent that has both immunosuppressive activity as well as antifibrotic (slowing down the rate of fibrosis or scarring in the lungs) properties. Participants will be placed into one of two treatment groups: Group A Belumosudil + standard of care medications for BOS versus Group B Belumosudil only. The U.S. Food and Drug Administration (FDA) has not approved belumosudil for the initial or preventative therapy of BOS, but it has been approved for the treatment of Chronic Graft Versus Host Disease (cGVHD). The other study drugs, Fluticasone, Azithromycin, Montelukast, and Prednisone are FDA approved as standard of care drugs for BOS. Study procedures include screening for eligibility, treatment visits, blood tests, pulmonary function tests, bronchoscopy wit bronchoalveolar lavage, and Computed Tomography (CT) Scans. Participants will receive study treatment for 11 months (48 weeks) and will be followed for an additional 12 months after completion of study treatment. It is expected that about 45 people (30 in Group A and 15 in Group B) will take part in this research study. The National Heart, Lung, and Blood Institute (NHLBI) is supporting this research study by providing funding. Sanofi is supporting this research study by providing study drug, Belumosudil.

Conditions

• Bronchiolitis Obliterans Syndrome
• Bronchiolitis Obliterans
• Lung Diseases
• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Belumosudil	Kinase inhibitor, tablet taken orally
DRUG	Fluticasone	Via inhalation by metered-dose inhaler.
DRUG	Azithromycin	Semi-synthetic macrolide antibiotic, taken orally
DRUG	Prednisone	Corticosteroid, taken orally
DRUG	Montelukast	Leukotriene Receptor Antagonist, taken orally

Timeline

• Start date: 2024-05-31
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2023-06-28
• Last updated: 2026-02-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study