Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease

• 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

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: Placebo

Drug: BT-11 880 mg

Primary Outcome(s)

Clinical Remission Rate [Time Frame: 12 weeks]

Secondary ID(s)

BT-11-202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/12/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03870334