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

NImmune Biopharma

Status and phase: Terminated; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: BT-11 880 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03870334

BT-11-202

Details and patient eligibility

About

This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.

Enrollment: 27 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months;
2. Moderately to severely active CD as defined by: a CDAI score of 220 450, and an SES-CD scored ≥ 6 ( ≥ 4 for isolated ileitis) (centrally read);

Key exclusion criteria:

1. Ulcerative colitis;
2. Known current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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27 participants in 2 patient groups, including a placebo group

BT-11 880 mg

Experimental group

Description:

Oral once daily tablet

Treatment:

Drug: BT-11 880 mg

Placebo

Placebo Comparator group

Description:

Oral once daily tablet

Treatment:

Drug: Placebo