Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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11 December 2023 |
Main ID: |
NCT03870334 |
Date of registration:
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08/03/2019 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
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Scientific title:
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A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease |
Date of first enrolment:
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May 5, 2021 |
Target sample size:
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27 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/ct2/show/NCT03870334 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Bulgaria
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Poland
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United States
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
1. Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months;
2. 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:
1. Ulcerative colitis;
2. Known current bacterial or parasitic pathogenic enteric infection; live virus
vaccination within 12 weeks of screening.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: BT-11 880 mg
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Drug: Placebo
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Primary Outcome(s)
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Clinical Remission Rate
[Time Frame: 12 weeks]
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Secondary ID(s)
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BT-11-202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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