- Participants with moderate to severe UC as defined by a total Mayo score of ≥6, with a
rectal bleeding subscore of ≥1 and an endoscopic subscore of ≥2;
- Participants must have inadequate response to, loss of response to, or intolerance to
at least one conventional therapy for UC: Oral, intravascular, or intramuscular
corticosteroids; Immunosuppressants (azathioprine [AZA], 6-MP, or methotrexate [MTX]);
Anti-tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab, or
golimumab); Anti-integrin inhibitors (eg, vedolizumab); JAK inhibitor (eg,
tofacitinib); Anti-IL-12/IL-23 inhibitors (eg, ustekinumab).
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, radiation colitis, and diverticular disease associated with colitis, or
- Participants displaying clinical signs of fulminant colitis or toxic megacolon;
- Participants with evidence of colonic dysplasia, adenomas or neoplasia.