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A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)

RecruitingPhase 2

A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Adult Participants With Moderately to Severely Active Ulcerative Colitis

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
The main inclusion criteria include but are not limited to the following:

* Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before Randomization
* Has moderately to severely active UC
* Has a weight ≥40 kg
* Satisfies at least 1 of the criteria: Has had an inadequate response or loss of response to 1 or more protocol-specified treatments; protocol specified corticosteroid dependence; has been intolerant to 1 or more protocol-specified UC treatments
* Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable

The main exclusion criteria include but are not limited to the following:

* Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment
* Has a current diagnosis of fulminant colitis and/or toxic megacolon
* Has UC limited to the rectum
* Has a current or impending need for colostomy or ileostomy
* Has had a total proctocolectomy or partial colectomy
* Has UC exacerbation requiring hospitalization within 2 weeks before Screening
* Has any active infection as specified in the protocol
* Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
* Has evidence of active tuberculosis (TB) or meets TB exclusionary parameters
* Has a history of cancer (except fully treated nonmelanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years before Randomization or has a history of colorectal cancer at any time
* Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
* Has had major surgery within 3 months before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study
* Has received protocol-specified prohibited medications

About the study

The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that MK-8690 is superior to placebo with respect to the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 100 · Started: Mar 24, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07463183

Locations in the U.S.

CaliforniaClinnova Research ( Site 1042), Anaheim
Southern California Research Center ( Site 1044), Coronado
ColoradoPeak Gastroenterology Associates ( Site 1052), Colorado Springs
South Denver Gastroenterology, PC ( Site 1068), Englewood
FloridaNature Coast Clinical Research ( Site 1045), Inverness
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072), Miami
AdventHealth Orlando ( Site 1074), Orlando
GeorgiaGastroenterology Associates of Central Georgia ( Site 1060), Macon
KansasUniversity of Kansas Medical Center ( Site 1077), Kansas City
LouisianaTulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073), New Orleans
MissouriBVL Research - Kansas ( Site 1054), Liberty

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.