A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
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
- Lung Transplant Rejection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Belumosudil + Azithromycin |
Participants will receive 200 mg belumosudil orally once daily |
|
|
Placebo Comparator Placebo + Azithromycin |
Participants will receive placebo orally once daily |
|
Recruiting Locations
Birmingham, Alabama 35233
Phoenix, Arizona 85013
Los Angeles, California 90095
Stanford, California 94305
Jacksonville, Florida 32224
Miami, Florida 33136
Orlando, Florida 32803
Tampa, Florida 33606
Atlanta, Georgia 30324
Chicago, Illinois 60611
Maywood, Illinois 60153
Iowa City, Iowa 52242
Baltimore, Maryland 21201
Baltimore, Maryland 21287
Boston, Massachusetts 02115
Ann Arbor, Michigan 48109
Grand Rapids, Michigan 49503
New York, New York 10016
New York, New York 10029
New York, New York 10032
The Bronx, New York 10467
Durham, North Carolina 27710
Cleveland, Ohio 44195
Columbus, Ohio 43210
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19140
Nashville, Tennessee 37232
Dallas, Texas 75390
Houston, Texas 77030
Houston, Texas 77030
San Antonio, Texas 78229
Falls Church, Virginia 22042
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