A clinical study of tulisokibart for the treatment of ulcerative colitis (MK-7240-005)

Prior treatment

• Has had surgical bowel resection within 3 months before screening

Other illness

• Has diagnosis of Crohn's disease or indeterminate colitis
• Has current evidence of fulminant colitis, toxic megacolon, bowel perforation, total proctocoloectomy or partial colectomy

Other

• The main exclusion criteria include but are not limited to the following:
• Has current or impending need for colostomy or ileostomy
• Has past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed

• The main inclusion criteria include but are not limited to the following:
• Confirmed diagnosis of ulcerative colitis (UC)
• Has moderately to severely active UC as defined by 3-component Modified Mayo score
• Must have corticosteroid dependence or have had no response, insufficient response, loss of response, and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (anti-TNF), anti-integrin, anti-interleukin 12/23 (anti-IL12/23), Janus kinase (JAK) inhibitor, Sphingosine 1-phosphate receptor (S1PR) modulator.