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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-02-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BT-11 880 mg

Oral once daily tablet

Group Type EXPERIMENTAL

BT-11

Intervention Type DRUG

Oral once daily tablet

Standard of care

Biologic

Group Type ACTIVE_COMPARATOR

Active comparator

Intervention Type DRUG

Biologic

Interventions

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BT-11

Oral once daily tablet

Intervention Type DRUG

Active comparator

Biologic

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No