Back to resultsEfficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BT-11 880 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility Criteria
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);
- Prior biologic must have stopped at least 8 weeks before study (or within 4 weeks prior to randomization, if no detectable drug levels by validated or commercial assay) and previous biologic treatment failure is limited to 1 class of biologic (if applicable);
- 5 aminosalicylates (max 4.8 g/day) and oral corticosteroids (max 20 mg/day prednisone or equivalent) must be stable for the duration of the 12-week induction period.
Key exclusion criteria:
- Ulcerative colitis;
- Imminent risk of ileocolectomy; symptomatic bowel stricture, ostomy or ileoanal pouch, stenoses, or short gut syndrome;
- Recent (within 2 months) abscess, unless drained and treated at least 6 weeks before randomization;
- History of bowel resection or diversion within 3 months prior to screening;
- Use of apheresis ≤ 2 weeks prior to screening; treatment with an immunosuppressant within 25 days prior to randomization;
- Known current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.
Sites / Locations
- Study Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BT-11 880 mg
Placebo
Arm Description
Oral once daily tablet
Oral once daily tablet
Outcomes
Primary Outcome Measures
Clinical remission rate
Clinical remission defined by CDAI score <150.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03870334
Brief Title
Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Decision of Landos Biopharma (not related to safety or efficacy)
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
August 26, 2022 (Actual)
Study Completion Date
August 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NImmune Biopharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BT-11 880 mg
Arm Type
Experimental
Arm Description
Oral once daily tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral once daily tablet
Intervention Type
Drug
Intervention Name(s)
BT-11 880 mg
Intervention Description
Oral once daily tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral once daily tablet
Primary Outcome Measure Information:
Title
Clinical remission rate
Description
Clinical remission defined by CDAI score <150.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Study Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33592
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
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