Last updated on July 2020

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


Brief description of study

Ulcerative colitis (UC) 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 is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 30-week double-blind Extended Treatment Phase (ETP) with 42-week Follow-Up Phase. Non-Responders identified following the Week 10 assessment will be allocated to open label treatment, consisting of Induction (Weeks 12 to 22), an Open label ETP (Weeks 22 to 42) and a follow-Up to Week 54. Approximately 242 participants will be included in the study.

Clinical Study Identifier: NCT03893565

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Rialto, CA United States
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Saint-Priest en Jarez, France
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Kaliningrad, Russian Federation
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St.Petersburg, Russian Federation
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Oklahoma City, OK United States
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Busan, Korea, Republic of
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Gangwon-do, Korea, Republic of
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Samara, Russian Federation
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Headington, United Kingdom
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Miami, FL United States
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Kamieniec Zabkowicki, Poland
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Recruitment Status: Open


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