Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 10 July 2023
• Main ID: NCT03861143
• Date of registration: 27/02/2019
• Prospective Registration: Yes
• Primary sponsor: NImmune Biopharma
• Public title: Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
• Scientific title: A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
• Date of first enrolment: August 14, 2019
• Target sample size: 198
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03861143
• 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

Belarus, Bosnia and Herzegovina, Croatia, Georgia, Hungary, Moldova, Republic of, Poland, Russian Federation, Serbia, Ukraine, United States

Key inclusion & exclusion criteria

Key Inclusion Criteria:

1. . Male and female subjects aged 18 to 75 years, inclusive.

2. . Diagnosis of UC for at least 3 months prior to screening.

3. . UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES 2
(confirmed by central reader).

4. . Able to participate fully in all aspects of this clinical trial.

5. . Written informed consent must be obtained and documented.

Key Exclusion Criteria:

1. . A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with
CD.

2. . Modified Truelove and Witts criteria (2: 6 bloody stools per day and one or more of
the following: pulse > 90 bpm, temperature > 37.8°C, hemoglobin < 10.5 g/dl, or hs-CRP
> 30 mg/I).

3. . Disease activity limited to distal 15 cm (proctitis).

4. . Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine [6-MP]) within
25 days prior to randomization.

5. . Unable to attend study visits or comply with procedures.

6. . Concurrent participation in any other interventional study.

7. . Prior enrollment in the current study and had received study treatment.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Placebo

Drug: BT-11 (440 mg)

Drug: BT-11 (880 mg)

Primary Outcome(s)

Clinical Remission [Time Frame: Week 12]

Secondary ID(s)

BT-11-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/11/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03861143