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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: ClinicalTrials.gov
Last refreshed on: 11 December 2023
Main ID:  NCT03870334
Date of registration: 08/03/2019
Prospective Registration: Yes
Primary sponsor: NImmune Biopharma
Public title: Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
Scientific 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
Date of first enrolment: May 5, 2021
Target sample size: 27
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/ct2/show/NCT03870334
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Bulgaria Poland United States
Contacts
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: BT-11 880 mg
Drug: Placebo
Primary Outcome(s)
Clinical Remission Rate [Time Frame: 12 weeks]
Secondary Outcome(s)
Secondary ID(s)
BT-11-202
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 04/12/2023
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT03870334
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