Last updated on May 2020

Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

Brief description of study

This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with mild to moderate UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.

Detailed Study Description

Following a 28-day screening period, a total of 195 subjects with mild to moderate UC (total Mayo Score 4-10; Mayo endoscopic subscore [MES] 2) are planned to be enrolled into this study from approximately 46 sites in Europe and the United States. Eligible subjects will be randomized in a 1:1:1 ratio to receive BT-11 low-dose (500 mg), BT-11 high-dose (1,000 mg) or placebo. Each of the treatment arms will comprise 65 subjects. The randomization will be stratified by prior exposure to biologic therapy for UC (yes/no; exposed population limited to 30% of total sample) and corticosteroid use at baseline (yes/no).

Clinical Study Identifier: NCT03861143

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Florida Research Institute

Lakewood Ranch, FL United States
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Recruitment Status: Open

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