A Phase 2a, Two-Part, Open-Label and Randomized Study to Evaluate the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Patients with Moderately to Severely Active Ulcerative Colitis (NCT06850727)

The purpose of this study is to evaluate the clinical efficacy and safety of OD-07656 in participants with moderately to severely active ulcerative colitis (UC). In addition, the study will evaluate the potential of OD-07656 to enhance the therapeutic benefit of vedolizumab when given after OD-07656.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Miles Sparrow

Key inclusion data

Main Inclusion Criteria: Has a confirmed diagnosis of ulcerative colitis (UC); Has moderate to severely active UC as defined by the 3-component Modified Mayo clinic score; Has an inadequate response, loss of response, or intolerance/medical contraindication to at least one of the following therapies: oral aminosalicylates, corticosteroids, immunosuppressants, anti-tumor necrosis factor biologic, anti-interleukin 12/23 biologic, Janus kinase inhibitors, or sphingosine-1-phosphate (S1P) modulators. Main Exclusion Criteria: Has diagnosis of Crohn's disease or indeterminate colitis; Has had extensive colonic resection; Has colostomy or ileostomy; Has uncontrolled primary sclerosing cholangitis.