Last updated on January 2020

Safety Tolerability Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis

Brief description of study

Ulcerative colitis is a form of inflammatory bowel disease characterized by chronic relapsing and remitting inflammation of the colon and rectum. There remains a high unmet need for novel treatments that achieve a higher rate of efficacy in resolving disease symptoms, and inducing and maintaining mucosal healing to achieve long-term corticosteroid-free remission. T cells are integral to the pathogenesis of ulcerative colitis, and clinical experience with anti-integrin monoclonal antibodies has established the principle of T cell-targeted therapies in the disease. GSK2831781 causes targeted depletion of Lymphocyte activation gene-3 (LAG3+) T cells, and has shown preliminary evidence of clinical efficacy in plaque psoriasis. It is therefore hypothesized that GSK2831781 will selectively deplete activated mucosal T cells in ulcerative colitis, but with relative sparing of resting T cells. This study will investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in subjects with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 20-week Extended Treatment Phase, and a 12-week Follow-Up Phase. Non-Responders allocated to open label treatment who subsequently respond to treatment may spend up to 54 weeks in total on study. Approximately 280 subjects will be included in the study.

Clinical Study Identifier: NCT03893565

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