Trial Details

Recruiting
Basic Information
Clinical ID c2671
Identifier ISRCTN14296856
Trial Title A randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of oral BT-11 in mild to moderate ulcerative colitis
Trial URL Visit Original Page
Study Information
Study Results

Yes
Conditions Ulcerative colitis Digestive System Ulcerative colitis
Interventions A total of 195 subjects with mild to moderate UC (total Mayo Score 4-10; MES 2:2) are planned to be enrolled into this study from approximately 46 centers 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 orally, once daily. Each of the treatment arms will comprise 65 subjects. The randomization will be stratified by prior exposure to biologic therapy for UC (yes/no) and corticosteroid use at baseline (yes/no). The study consists of a 28-day screening period, a 12-week induction phase, and a 2-week post-treatment safety follow-up period. Upon completion of the study, subjects will be eligible to receive ongoing therapy as part of longer-term studies.
Participant Information
Sponsor Landos Biopharma Inc.
City -
Country/Region Belarus;Bosnia and Herzegovina;Croatia;Georgia;Hungary;Moldova;Poland;Russia;Serbia;Ukraine;United States
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Interventional
Phase PHASE2
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2025-06-15