Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 195
Summary
- Conditions
- Ulcerative Colitis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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. 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).Masking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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 ra...
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).
Tracking Information
- NCT #
- NCT03861143
- Collaborators
- Not Provided
- Investigators
- Study Director: Jyoti Chauhan Landos Biopharma Inc.
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