Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease

A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease

This is a phase 2, randomized, double-blind, multicenter study to assess the therapeutic efficacy, safety, and mechanisms of omilancor (BT-11) in patients with moderate to severe Crohn's Disease (CD).

Study Overview

• Status: Withdrawn
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: BT-11; Drug: Active comparator

Detailed Description

This is a randomized, double-blind, phase II study intending to evaluate omilancor (BT-11). The study will be conducted at multiple sites within the Icahn School of Medicine system at Mount Sinai. 40 subjects with moderate to severe CD will be randomized to receive either omilancor (BT-11) or adalimumab. The duration of treatment will be 12 weeks. Participants will be asked to visit the medical facility at baseline, 2, 6, and 12 weeks. At each visit blood, urine and fecal samples will be collected as well as an overall assessment of symptoms and patient reported outcomes. Participants will be asked to visit the facility at weeks 4, 8, and 10 for dosing on adalimumab and SC placebo. At screening and 12 weeks, subjects will undergo an endoscopy to assess endoscopic response and collect colonic biopsies. After completing week 12 of the study, subjects may be given the chance to be in an optional open-label extension study. All eligible subjects will receive treatment with omilancor (BT-11) 1000 mg daily. Participants who are classified as non-responders will be discontinued from the study. Participants who continue to respond to study treatment will have the option of remaining on omilancor (BT-11) until the therapy becomes commercially available or the sponsor decides to terminate the study.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Male and female subjects age 18 to 75 years, inclusive.
2. Diagnosis of CD for at least 6 weeks prior to screening

3. Moderate to severely active CD as defined by all of the following:

   • CDAI score of 220-450
   • PRO-2 stool frequency (SF) ≥ 4 and/or abdominal pain (AP) ≥ 2
   • SES-CD ≥ 6 ( ≥4 for isolated ileitis) scored by a blinded central reader

Key Exclusion Criteria:

1. Participant has ulcerative colitis
2. Participant is at imminent risk of ileo-colectomy
3. Prior enrolment 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BT-11 880 mg; Oral once daily tablet	Drug: BT-11; Oral once daily tablet
Active Comparator: Standard of care; Biologic	Drug: Active comparator; Biologic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biomarkers of reponse	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
In the active BT-11 treatment group, BT-11 concentration in serum, feces, and tissue.	12 weeks
Frequency and severity of AEs compared to adalimumab during the 12-week induction period	12 weeks
Results of physical examinations like weight	12 weeks
Changes in hematology from baseline by complete hemogram	12 weeks

Collaborators and Investigators

• Sponsor: NImmune Biopharma

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2021
• Primary Completion (Estimated): February 1, 2022
• Study Completion (Estimated): February 1, 2022

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: BT-11-202B

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