Clinical Trials Logo

Clinical Trial 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). 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05057273
Study type Interventional
Source Landos Biopharma Inc.
Contact Josep Bassaganya Riera
Phone 5402182232
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date September 2021
Completion date February 2022

See also
  Status Clinical Trial Phase
Completed NCT02883452 - A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis Phase 1
Terminated NCT03017014 - A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Active, not recruiting NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Not yet recruiting NCT03992469 - Study to Evaluate Safety, Tolerability and Efficacy of Oral B-FAHF-2 in Mild-to-Moderate Crohn's Disease Phase 1
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A
Terminated NCT02882841 - MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients N/A
Completed NCT02542917 - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Terminated NCT02417974 - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) Phase 2
Completed NCT03010787 - A First Time in Human Study in Healthy Volunteers and Patients Phase 1
Recruiting NCT02193048 - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Active, not recruiting NCT02316678 - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics N/A
Active, not recruiting NCT02265588 - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
Completed NCT01958827 - A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease Phase 3
Completed NCT01951326 - Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease Phase 3
Recruiting NCT01632462 - A Prospective, Placebo Controlled, Double-Blind, Cross-over Study on the Effects of a Probiotic Preparation (VSL#3) on Metabolic Profile, Intestinal Permeability, Microbiota, Cytokines and Chemokines Expression and Other Inflammatory Markers in Pediatric Patients With Crohn's Disease Phase 4
Completed NCT01697761 - Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease N/A
Completed NCT01696838 - Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With fMRI N/A