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

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease

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

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.