Tests MK-8690 for moderately to severely active ulcerative colitis
Tests MK-8690 against placebo in adults with active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
Key facts
- Where
- Anaheim, Colorado Springs, Coronado, Englewood, Inverness, Kansas City, Liberty, Macon, Miami, New Orleans, and Orlando, United StatesSee the 11 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07463183, who can take part
Where in United States
- Clinnova Research (Site 1042)Anaheim, United StatesTaking people
- Peak Gastroenterology Associates (Site 1052)Colorado Springs, United StatesTaking people
- Southern California Research Center (Site 1044)Coronado, United StatesTaking people
- South Denver Gastroenterology, PC (Site 1068)Englewood, United StatesTaking people
- Nature Coast Clinical Research (Site 1045)Inverness, United StatesTaking people
- University of Kansas Medical Center (Site 1077)Kansas City, United StatesTaking people
- BVL Research - Kansas (Site 1054)Liberty, United StatesTaking people
- Gastroenterology Associates of Central Georgia (Site 1060)Macon, United StatesTaking people
- Research Associates of South Florida - Miami - Southwest 8th Street (Site 1072)Miami, United StatesTaking people
- Tulane University School of Medicine-Gastroenterology and Hepatology (Site 1073)New Orleans, United StatesTaking people
- AdventHealth Orlando (Site 1074)Orlando, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07463183EU 2025-523479-49-00
- Record updated
- 23 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
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.