Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis

Key Inclusion Criteria:

• Individuals assigned male at birth, or nonpregnant, nonlactating individualsassigned female at birth, 18 to 75 years of age based on the date of the screeningvisit.

• Ulcerative colitis (UC) of at least 90-day duration before randomization confirmedby endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent withthe diagnosis of UC must be available in the source documents prior to theinitiation of screening.

• Moderately to severely active UC as determined during screening with a modified MayoClinic Score based on the sum of Stool Frequency, Rectal Bleeding, and EndoscopicFinding of 5 to 9 points and an endoscopic subscore of 2 to 3 (determined by centralreader).

• Previous treatment history of approved UC therapy with at least one advanced therapymechanisms of action but failure (ie, loss of response or lack of response) of nomore than 3 different advanced therapy mechanisms of action.

• A surveillance colonoscopy for dysplasia is required prior to randomization ifindicated by regional guidelines for individuals with UC.

Key Exclusion Criteria:

• Current diagnosis of Crohn's Disease (CD) or diagnosis of indeterminate colitis dueto an enteric pathogen, lymphocytic or collagenous colitis.

• Individuals with disease limited to the rectum (ulcerative proctitis) duringscreening endoscopy.

• Requirement for ongoing therapy with or prior use of any prohibited medications.

• Active clinically significant infection, or any infection requiring hospitalizationor treatment with intravenous anti-infectives within 8 weeks.

of randomization; or any infection requiring oral anti-infective therapy within 6 weeks of randomization.

• History of opportunistic infection.

• Current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.