Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861143
• Other study ID #: BT-11-201
• Status: Completed
• Phase: Phase 2
• Start date: August 14, 2019
• Est. completion date: June 17, 2021

Study information

• Verified date: June 2023
• Source: NImmune Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 17, 2021
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• BT-11 (440 mg)
Oral, once daily tablet
• BT-11 (880 mg)
Oral, once daily tablet
• Placebo
Oral, once daily tablet

Locations

Country	Name	City	State
Bosnia and Herzegovina	Polyclinic and Daily hospital "Dr Al Tawil"	Sarajevo	Federation BiH
Bosnia and Herzegovina	Cantonal Hospital Zenica, Gastroenterology	Zenica
Croatia	Polyclinic Duvnjak	Zagreb
Poland	Centrum Badan Klinicznych PI-House Sp. z o.o.	Gdansk	Pomorskie
Poland	RIVERM E D Sp. zo.o.	Poznan	Wielkopolskie
Ukraine	Municipal Non-profit Enterprise "City Outpatient Clinic No 9 of Kharkiv City Council, Surgery department, Kharkiv	Kharkiv
Ukraine	Multidisciplinary Medical Center of Odesa National Medical University, First Surgery Department ,Odesa National Medical University , Chair of General and Military Surgeon	Odesa
United States	Medycal Research Inc.	Brooksville	Florida
United States	Invesclinic.U.S,LLC.FL	Fort Lauderdale	Florida
United States	I.H.S Health LLC	Kissimmee	Florida
United States	Axis Clinical Trials	Los Angeles	California
United States	Invesclinic.U.S,LLC.	McAllen	Texas
United States	Smart Medical Research	Richmond Hill	New York
United States	Texas Gastroenterology Associates	Spring	Texas
United States	Ventura Clinical Trials	Ventura	California
United States	Clinical Research of California	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
NImmune Biopharma

Countries where clinical trial is conducted

United States,  Bosnia and Herzegovina,  Croatia,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Remission	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.	Week 12