A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)
A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.
Key Inclusion Criteria:
Key Exclusion Criteria:
Scottsdale, Arizona 85258-4547, United States
Stanford, California 94305, United States
Washington D.C., District of Columbia 20010, United States
Miami, Florida 33136-1096, United States
Orlando, Florida 32804, United States
Indianapolis, Indiana 46202-5112, United States
Boston, Massachusetts 02114, United States
Hackensack, New Jersey 07601, United States
New York, New York 10021, United States
New York, New York 10032-1559, United States
New York, New York 10065, United States
Chapel Hill, North Carolina 27516, United States
Pittsburgh, Pennsylvania 15232, United States
Charleston, South Carolina 29425, United States
Nashville, Tennessee 37232-5280, United States
Graz, 8036, Austria
Vancouver, British Columbia V5Z 1M9, Canada
Paris, Île-de-France Region 75010, France
Turin, 10126, Italy
Hiroshima, Hiroshima 730-8619, Japan
Nishinomiya-shi, Hyōgo 663-8501, Japan
Isehara-shi, Kanagawa 259-1193, Japan
Kurishiki-shi, Okayama-ken 710-8602, Japan
Izumi-Shi, Osaka 594-1101, Japan
Bunkyo-ku, Tokyo 113-8677, Japan
Setagaya-ku, Tokyo 157-8535, Japan
Singapore, 119228, Singapore
Seodaemun-gu, Seoul Teugbyeolsi 03722, South Korea
Taipei City, Taipei 10002, Taiwan