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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05057273

Enrollment

Registered

2021-09-27

Start date

2021-11-30

Completion date

2022-02-28

Last updated

2023-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Brief summary

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).

Interventions

DRUGBT-11

Oral once daily tablet

DRUGActive comparator

Biologic

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Biomarkers of reponse	12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026