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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)

NCT07463183 · Merck Sharp & Dohme LLC
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Official title
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
About this 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.
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
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2026-03-24
Estimated completion: 2028-12-21
Last updated: 2026-05-26
Interventions
Drug: MK-8690Other: Placebo
Primary outcomes
  • Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12 (Week 12)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (8)
Clinnova Research ( Site 1042)Recruiting
Anaheim, California, United States
Peak Gastroenterology Associates ( Site 1052)Recruiting
Colorado Springs, Colorado, United States
South Denver Gastroenterology, PC ( Site 1068)Recruiting
Englewood, Colorado, United States
Nature Coast Clinical Research ( Site 1045)Recruiting
Inverness, Florida, United States
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)Recruiting
Miami, Florida, United States
Gastroenterology Associates of Central Georgia ( Site 1060)Recruiting
Macon, Georgia, United States
Tulane University School of Medicine ( Site 1073)Recruiting
New Orleans, Louisiana, United States
BVL Research - Kansas ( Site 1054)Recruiting
Liberty, Missouri, United States
A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002) · TrialPath