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Completed

NCT Number: NCT03861143

Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Polyclinic and Daily hospital "Dr Al Tawil", Sarajevo, Federation BiH, Bosnia and Herzegovina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • . Male and female subjects aged 18 to 75 years, inclusive.
  • . Diagnosis of UC for at least 3 months prior to screening.
  • . UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES 2 (confirmed by central reader).
  • . Able to participate fully in all aspects of this clinical trial.
  • . Written informed consent must be obtained and documented.

Key Exclusion Criteria:

  • . A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with CD.
  • . 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).
  • . Disease activity limited to distal 15 cm (proctitis).
  • . Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine [6-MP]) within 25 days prior to randomization.
  • . Unable to attend study visits or comply with procedures.
  • . Concurrent participation in any other interventional study.
  • . Prior enrollment in the current study and had received study treatment.

Treatment and study plan

BT-11 (440 mg)

Drug

Oral, once daily tablet

BT-11 (880 mg)

Drug

Oral, once daily tablet

Placebo

Drug

Oral, once daily tablet

Primary outcomes

  1. Clinical Remission

    Time frame: Week 12

    Clinical remission rate at Week 12, defined using the 3-component modified Mayo Score as a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and an endoscopic subscore of 0 or 1.

Sponsors and collaborators

Lead sponsor

NImmune Biopharma

Industry

Registry information

Official study title

A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 4, 2019
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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