Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis

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 Mayoclinic score

• Has an inadequate response, loss of response, or intolerance/medicalcontraindication 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