This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first.
Chronic Graft Versus Host Disease
This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first.
A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.
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University of Arkansas for Medical Sciences-Site Number : 8400019, Little Rock, Arkansas, United States, 72205
City of Hope National Medical Center- Site Number : 8400001, Duarte, California, United States, 91010
AdventHealth Orlando- Site Number : 8400023, Orlando, Florida, United States, 32803
Emory University School of Medicine- Site Number : 8400020, Atlanta, Georgia, United States, 30322-1007
Northwestern University- Site Number : 8400017, Chicago, Illinois, United States, 60611
University of Kentucky Chandler Medical Center- Site Number : 8400024, Lexington, Kentucky, United States, 40536
Dana Farber Cancer Institute Site Number : 8400005, Boston, Massachusetts, United States, 02115
Karmanos Cancer Institute - Detroit- Site Number : 8400013, Detroit, Michigan, United States, 48201
UNC Children's Hospital- Site Number : 8400025, Chapel Hill, North Carolina, United States, 27514
Wake Forest Baptist Medical Center - Winston-Salem - Medical Center Boulevard- Site Number : 8400007, Winston-Salem, North Carolina, United States, 27157
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
12 Years to
ALL
No
Sanofi,
2028-09-29