Actively Recruiting
A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-21
100
Participants Needed
7
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
Who Can Participate
Eligibility Criteria
You may qualify if you...
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
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Clinnova Research ( Site 1042)
Anaheim, California, United States, 92805
Actively Recruiting
2
Peak Gastroenterology Associates ( Site 1052)
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
3
South Denver Gastroenterology, PC ( Site 1068)
Englewood, Colorado, United States, 80113
Actively Recruiting
4
Nature Coast Clinical Research ( Site 1045)
Inverness, Florida, United States, 34452
Actively Recruiting
5
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)
Miami, Florida, United States, 33134
Actively Recruiting
6
Gastroenterology Associates of Central Georgia ( Site 1060)
Macon, Georgia, United States, 31201
Actively Recruiting
7
BVL Research - Kansas ( Site 1054)
Liberty, Missouri, United States, 64068
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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