Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate 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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: BT-11 (440 mg); Drug: BT-11 (880 mg); Drug: Placebo

Detailed Description

Following a 28-day screening period, a total of 195 subjects with mild to moderate UC (total Mayo Score 4-10; Mayo endoscopic subscore [MES] ≥ 2) are planned to be enrolled into this study from approximately 46 sites in Europe and the United States. Eligible subjects will be randomized in a 1:1:1 ratio to receive BT-11 low-dose (500 mg), BT-11 high-dose (1,000 mg) or placebo. Each of the treatment arms will comprise 65 subjects. The randomization will be stratified by prior exposure to biologic therapy for UC (yes/no; exposed population limited to 30% of total sample) and corticosteroid use at baseline (yes/no).

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Zenica, Bosnia and Herzegovina, 72000
    • Cantonal Hospital Zenica, Gastroenterology
  • Federation BiH
    • Sarajevo, Federation BiH, Bosnia and Herzegovina, 71000
      • Polyclinic and Daily hospital "Dr Al Tawil"
• Croatia
  • Zagreb, Croatia, 10000
    • Polyclinic Duvnjak
• Poland
  • Pomorskie
    • Gdańsk, Pomorskie, Poland, 80546
      • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Wielkopolskie
    • Poznań, Wielkopolskie, Poland, 61441
      • RIVERM E D Sp. zo.o.
• Ukraine
  • Kharkiv, Ukraine, 61172
    • Municipal Non-profit Enterprise "City Outpatient Clinic No 9 of Kharkiv City Council, Surgery department, Kharkiv
  • Odesa, Ukraine, 65082
    • Multidisciplinary Medical Center of Odesa National Medical University, First Surgery Department ,Odesa National Medical University , Chair of General and Military Surgeon
• United States
  • California
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
    • Ventura, California, United States, 93003
      • Ventura Clinical Trials
    • Walnut Creek, California, United States, 94598
      • Clinical Research of California
  • Florida
    • Brooksville, Florida, United States, 34613
      • Medycal Research Inc.
    • Fort Lauderdale, Florida, United States, 33308
      • Invesclinic.U.S,LLC.FL
    • Kissimmee, Florida, United States, 34741
      • I.H.S Health LLC
  • New York
    • Richmond Hill, New York, United States, 11102
      • Smart Medical Research
  • Texas
    • McAllen, Texas, United States, 78503
      • Invesclinic.U.S,LLC.
    • Spring, Texas, United States, 77386
      • Texas Gastroenterology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BT-11 low-dose (440 mg); Oral, once daily tablet	Drug: BT-11 (440 mg); Oral, once daily tablet
Experimental: BT-11 high-dose (880 mg); Oral, once daily tablet	Drug: BT-11 (880 mg); Oral, once daily tablet
Placebo Comparator: Placebo; Oral, once daily tablet	Drug: Placebo; Oral, once daily tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic Response Rate	Patient with a Mayo score of 0 or 1. The Mayo Clinic Score System has a scale of 0 to 3, whereas zero indicates no evidence of ulcerative colitis and 3 indicating severe ulcerative colitis.	12 weeks
Mucosal Healing Rate	Mayo Endoscopic Score of 0 or 1 and a Geboes Histologic Index score of less than 3.1. The Mayo Endoscopic Score has a scale of 0 to 3, whereas zero indicates no evidence of ulcerative colitis and 3 indicates severe ulcerative colitis. The Geboes Histologic Index score has a scale of grades from 0.0 to 4.4, whereas zero indicates no abnormalities and 4.4 indicates ulcers or granulation tissue	12 weeks
Change in Fecal Calprotectin From Baseline and 12 Weeks	Change in fecal calprotectin from baseline and 12 weeks	Baseline and 12 weeks
Concentration of BT-11 in Stool at Week 12	Concentration of BT-11 in Stool at Week 12	Week 12
Number of Participants With Treatment-related Adverse Events	Number of participants with treatment-related adverse events - subjects with >= 1 AE by Max. Treatment Relation (Possibly related and Probably related)	up to 12 weeks

Collaborators and Investigators

• Sponsor: NImmune Biopharma

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2019
• Primary Completion (Actual): December 10, 2020
• Study Completion (Actual): June 17, 2021

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: BT-11-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No