Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

NCT03861143 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BT-11-201
• Study Type: interventional
• Target: 198
• Locations: 5 countries
• Sites: 16

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

BT-11 low-dose (440 mg)

EXPERIMENTAL

Oral, once daily tablet

Drug: BT-11 (440 mg)

BT-11 high-dose (880 mg)

EXPERIMENTAL

Oral, once daily tablet

Drug: BT-11 (880 mg)

Placebo

PLACEBO COMPARATOR

Oral, once daily tablet

Drug: Placebo

Interventions

BT-11 (440 mg) DRUG

Oral, once daily tablet

BT-11 low-dose (440 mg)

BT-11 (880 mg) DRUG

Oral, once daily tablet

BT-11 high-dose (880 mg)

Placebo DRUG

Oral, once daily tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NImmune Biopharma: lead

Study Sites (16)

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Ventura Clinical Trials

Ventura, California, 93003, United States

Location

Clinical Research of California

Walnut Creek, California, 94598, United States

Location

Medycal Research Inc.

Brooksville, Florida, 34613, United States

Location

Invesclinic.U.S,LLC.FL

Fort Lauderdale, Florida, 33308, United States

Location

I.H.S Health LLC

Kissimmee, Florida, 34741, United States

Location

Smart Medical Research

Richmond Hill, New York, 11102, United States

Location

Invesclinic.U.S,LLC.

McAllen, Texas, 78503, United States

Location

Texas Gastroenterology Associates

Spring, Texas, 77386, United States

Location

Polyclinic and Daily hospital "Dr Al Tawil"

Sarajevo, Federation BiH, 71000, Bosnia and Herzegovina

Location

Cantonal Hospital Zenica, Gastroenterology

Zenica, 72000, Bosnia and Herzegovina

Location

Polyclinic Duvnjak

Zagreb, 10000, Croatia

Location

RIVERM E D Sp. zo.o.

Poznan, Greater Poland Voivodeship, 61441, Poland

Location

Centrum Badan Klinicznych PI-House Sp. z o.o.

Gdansk, Pomeranian Voivodeship, 80546, Poland

Location

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

Kharkiv, 61172, Ukraine

Location

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

Odesa, 65082, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Clinical Development
• Organization: NImmune Biopharma, Inc.

info@nimmunebio.com

(540) 218-2262

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: February 27, 2019
• First Posted: March 4, 2019
• Study Start: August 14, 2019
• Primary Completion: December 10, 2020
• Study Completion: June 17, 2021
• Last Updated: June 29, 2023
• Results First Posted: November 3, 2022

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2); US (9); UA (2); CR (1); BO (2)