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

NImmune Biopharma

Status and phase: Withdrawn; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Active comparator; Drug: BT-11

Study type: Interventional

Funder types: Industry

Identifiers

NCT05057273

BT-11-202B

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

BT-11 880 mg

Experimental group

Description:

Oral once daily tablet

Treatment:

Drug: BT-11

Standard of care

Active Comparator group

Description:

Biologic

Treatment:

Drug: Active comparator