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

  • STATUS
    Not Recruiting
  • End date
    May 19, 2023
  • participants needed
    242
  • sponsor
    GlaxoSmithKline
Updated on 24 February 2021
cancer
corticosteroids
remission
cyclosporine
methotrexate
monoclonal antibodies
endoscopy
adalimumab
infliximab
tumor necrosis factor
mercaptopurine
inflammatory bowel disease
azathioprine
biosimilar
tumor necrosis factor alpha
golimumab
tumour necrosis
hematochezia
thiopurines
intestinal diseases
pancolitis
sigmoidoscopy or colonoscopy

Summary

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.

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment Placebo, GSK2831781, Placebo IV Infusion, GSK2831781 IV infusion, GSK2831781 SC injection, Placebo SC injection
Clinical Study IdentifierNCT03893565
SponsorGlaxoSmithKline
Last Modified on24 February 2021

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