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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant ≥1 year post bilateral lung transplantation at the time of screening - Participants presenting with CLAD - Participants who have received at least 8 weeks of azithromycin

Exclusion Criteria

  • Lung function decline that can be explained by non-CLAD causes including but not limited to acute lung allograft rejection (>A1), antibody-mediated rejection within 4 weeks of screening, airway stenosis, or tracheobronchomalacia - Participants who have received other treatments for CLAD

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Belumosudil + Azithromycin 		Participants will receive 200 mg belumosudil orally once daily
  • Drug: Belumosudil
    Tablet, Oral
    Other names:
    • REZUROCK
  • Drug: Azithromycin
    Depends on pharmaceutical presentation, Oral
Placebo Comparator
Placebo + Azithromycin 		Participants will receive placebo orally once daily
  • Drug: Azithromycin
    Depends on pharmaceutical presentation, Oral
  • Drug: Placebo
    Tablet, Oral

Recruiting Locations

University of Alabama at Birmingham- Site Number : 8400026
Birmingham, Alabama 35233

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free number for US & Canada)
800-633-1610
contact-us@sanofi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.