潰瘍性大腸炎におけるGSK2831781の安全性、忍容性、有効性および用量反応

基本情報

NCT ID

NCT03893565

ステータス

中止

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

104

治験依頼者名

GlaxoSmithKline

概要

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.

対象疾患

介入

依頼者（Sponsor）