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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2019
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.
Epistemonikos ID: 0850e6f0fd5dac2aa3554ee42a759f83687e6aca
First added on: Mar 23, 2022