Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
130

Summary

Conditions
Crohn's Disease
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 induction study. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 induction compared to placebo in subjects with moderate to severe CD. Approximately 100 sites will participate from Europe and the USA. A total of 150 subjects with moderate to severe CD (CDAI Score 220-450 and a Simplified Endoscopic Index of Severity of Chron's Disease (SES-CD) SCORED ? 6 (? 4 for isolated ileitis) will be randomized in a 1:1 ratio to receive BT-11 1,000 mg or placebo. Each of the treatment arms will comprise 75 subjects. The randomization will be stratified by prior exposure to biologic therapy for CD (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.Masking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

A total of 150 subjects will be randomized in a 1:1 ratio, in a centralized manner, to receive BT 11 1000 mg or placebo. Each of the treatment arms will comprise 75 subjects. The randomization will be stratified by prior exposure to biologic therapy for CD (yes/no; exposed population limited to 50% ...

A total of 150 subjects will be randomized in a 1:1 ratio, in a centralized manner, to receive BT 11 1000 mg or placebo. Each of the treatment arms will comprise 75 subjects. The randomization will be stratified by prior exposure to biologic therapy for CD (yes/no; exposed population limited to 50% of total sample) and corticosteroid use at baseline (yes/no). The study will consist of a 28-day screening period, a 12-week induction period, an 18-week maintenance period, and a 2-week posttreatment safety follow-up period. Subjects who are nonresponders at Week 12, or who lose response during the maintenance period, or who complete the Week 30 study will be eligible for a separate open-label extension (OLE) study.

Tracking Information

NCT #
NCT03870334
Collaborators
Not Provided
Investigators
Study Director: Jyoti Chauhan Landos Biopharma Inc.