Overview
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.
Eligibility
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- 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
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has diagnosis of Crohn's disease or indeterminate colitis
- Has had extensive colonic resection
- Has colostomy or ileostomy
- Has uncontrolled primary sclerosing cholangitis