Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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% 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33592
- Study Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months;
- Moderately to severely active CD as defined by: a CDAI score of 220 450, and an SES-CD scored ≥ 6 ( ≥ 4 for isolated ileitis) (centrally read);
Key exclusion criteria:
- Ulcerative colitis;
- Known current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BT-11 880 mg
Oral once daily tablet
|
Oral once daily tablet
|
|
Placebo Comparator: Placebo
Oral once daily tablet
|
Oral once daily tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Remission Rate
Time Frame: 12 weeks
|
Clinical remission defined by CDAI score <150.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical response
Time Frame: 12 weeks
|
CDAI reduction from baseline ≥ 100 points or CDAI < 150
|
12 weeks
|
|
Endoscopic remission
Time Frame: 12 weeks
|
SES-CD OF 0-2 or SES-CD ≤ 4, a ≥2-point improvement over baseline, and no sub-score > 1
|
12 weeks
|
|
Histologic Remission
Time Frame: 12 weeks
|
Geboes score < 2B.1 (with absence of neutrophils in lamina propria)
|
12 weeks
|
|
Endoscopic Response
Time Frame: 12 weeks
|
Proportion of subjects achieving clinical remission defined as 50% reduction from baseline in SES-CD score at week 12
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BT-11-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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