Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

Phase 2

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: BT-11 (880 mg); Drug: Placebo; Drug: BT-11 (440 mg)

• Registration Number: NCT03861143
• Lead Sponsor: NImmune Biopharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-04
• Study Start: 2019-08-14
• Primary Completion: 2020-12-10
• Study Completion: 2021-06-17
• Results First Submitted: 2022-07-15
• Results First Submitted QC: 2022-10-10
• Results First Posted: 2022-11-03
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BT-11 high-dose (880 mg)	BT-11 (880 mg)	Oral, once daily tablet
Placebo	Placebo	Oral, once daily tablet
BT-11 low-dose (440 mg)	BT-11 (440 mg)	Oral, once daily tablet

Primary Outcome Measures

Name	Time	Method
Clinical Remission	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.

Trial Locations

Locations (16)

Invesclinic.U.S,LLC.FL; 🇺🇸 Fort Lauderdale, Florida, United States

Invesclinic.U.S,LLC.; 🇺🇸 McAllen, Texas, United States

I.H.S Health LLC; 🇺🇸 Kissimmee, Florida, United States

Ventura Clinical Trials; 🇺🇸 Ventura, California, United States

Clinical Research of California; 🇺🇸 Walnut Creek, California, United States

Polyclinic Duvnjak; 🇭🇷 Zagreb, Croatia

Medycal Research Inc.; 🇺🇸 Brooksville, Florida, United States

Texas Gastroenterology Associates; 🇺🇸 Spring, Texas, United States

Smart Medical Research; 🇺🇸 Richmond Hill, New York, United States

RIVERM E D Sp. zo.o.; 🇵🇱 Poznań, Wielkopolskie, Poland

Multidisciplinary Medical Center of Odesa National Medical University, First Surgery Department ,Odesa National Medical University , Chair of General and Military Surgeon; 🇺🇦 Odesa, Ukraine

Cantonal Hospital Zenica, Gastroenterology; 🇧🇦 Zenica, Bosnia and Herzegovina

Axis Clinical Trials; 🇺🇸 Los Angeles, California, United States

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

Centrum Badan Klinicznych PI-House Sp. z o.o.; 🇵🇱 Gdańsk, Pomorskie, Poland

Municipal Non-profit Enterprise "City Outpatient Clinic No 9 of Kharkiv City Council, Surgery department, Kharkiv; 🇺🇦 Kharkiv, Ukraine