This is a randomized, double-blind, phase II study intending to evaluate omilancor (BT-11). The study will be conducted at multiple sites within the Icahn School of Medicine system at Mount Sinai. 40 subjects with moderate to severe CD will be randomized to receive either omilancor (BT-11) or adalimumab. The duration of treatment will be 12 weeks. Participants will be asked to visit the medical facility at baseline, 2, 6, and 12 weeks. At each visit blood, urine and fecal samples will be collected as well as an overall assessment of symptoms and patient reported outcomes. Participants will be asked to visit the facility at weeks 4, 8, and 10 for dosing on adalimumab and SC placebo. At screening and 12 weeks, subjects will undergo an endoscopy to assess endoscopic response and collect colonic biopsies. After completing week 12 of the study, subjects may be given the chance to be in an optional open-label extension study. All eligible subjects will receive treatment with omilancor (BT-11) 1000 mg daily. Participants who are classified as non-responders will be discontinued from the study. Participants who continue to respond to study treatment will have the option of remaining on omilancor (BT-11) until the therapy becomes commercially available or the sponsor decides to terminate the study.
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). The purpose of this study is to evaluate target engagement and the mechanism of action of BT-11 compared to adalimumab in subjects with moderately to severely active CD.