Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT03870334|
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : September 23, 2022
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: BT-11 1,000 mg Drug: Placebo||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 Crohn'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)|
|Official Title:||A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease|
|Actual Study Start Date :||May 5, 2021|
|Actual Primary Completion Date :||August 26, 2022|
|Actual Study Completion Date :||August 26, 2022|
Experimental: BT-11 1,000 mg
Eligible subjects will be randomly assigned, in a centralized manner, in a 1:1 ratio to 1 of 2 treatment groups, (omilancor) BT-11 1000 mg or placebo, through an interactive web-based response system (IWRS).
Drug: BT-11 1,000 mg
Subjects will be randomized to receive BT-11 1,000 mg once-daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive blister packs of the study drug (BT-11, or placebo).
Placebo Comparator: Placebo
Subjects in the (omilancor) BT-11 group will receive 1000 mg of BT-11 and subjects in the placebo group will receive matched placebo. Subjects will take study drug by ingesting 1 tablet per day with water.
Subjects will be randomized to receive Placebo once daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive blister packs of the study drug (BT-11, or placebo).
- Clinical remission rate [ Time Frame: 12 weeks ]Clinical remission defined by CDAI score <150.
- Clinical response [ Time Frame: 12 weeks ]CDAI reduction from baseline ≥ 100 points or CDAI < 150
- 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
- Histologic Remission [ Time Frame: 12 weeks ]Geboes score < 2B.1 (with absence of neutrophils in lamina propria)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870334
|Study Director:||Simon Lichtiger, MD||Landos Biopharma Inc.|