Actively Recruiting
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
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-26
100
Participants Needed
8
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug MK-8690 in adults with moderately to severely active ulcerative colitis. The study aims to determine if MK-8690 is better than a placebo in helping participants achieve clinical remission by Week 12, using the Modified Mayo Score. This Phase 2a trial is sponsored by Merck Sharp & Dohme LLC and focuses on improving outcomes for adults who have had ulcerative colitis for at least three months. Participants are randomly assigned to receive either MK-8690 or a placebo via subcutaneous injections for 12 weeks in the first study period. Those who do not respond to treatment in this initial phase will receive MK-8690 for another 12 weeks. Participants who respond in either of the first two periods can continue MK-8690 injections for up to approximately 42 additional weeks. This trial uses a triple-blind design to maintain unbiased results. Throughout the study, participants will undergo regular assessments to evaluate clinical remission, response, endoscopic improvement, and mucosal healing. Researchers will monitor safety by recording adverse events and any treatment discontinuations due to side effects for up to about one year. The total participation duration can extend through multiple treatment periods and long-term follow-up to assess both effectiveness and safety over time.
CONDITIONS
Brief 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...
- Has had ulcerative colitis for at least 3 months before randomization
- Has moderately to severely active ulcerative colitis
- Weighs at least 40 kg
- Has had inadequate response, loss of response, corticosteroid dependence, or intolerance to one or more protocol-specified ulcerative colitis treatments
- Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements as applicable
You will not qualify if you...
- Diagnosis of Crohn's Disease, indeterminate colitis, or other types of colitis or enteritis that may affect efficacy assessment
- Current diagnosis of fulminant colitis and/or toxic megacolon
- Ulcerative colitis limited to the rectum
- Current or impending need for colostomy or ileostomy
- History of total proctocolectomy or partial colectomy
- Ulcerative colitis exacerbation requiring hospitalization within 2 weeks before screening
- Any active infection as specified in the protocol
- Known infection with hepatitis B, hepatitis C, or HIV
- Evidence of active tuberculosis or meets tuberculosis exclusion criteria
- History of cancer (except certain treated skin or cervical cancers) within 5 years or any history of colorectal cancer
- Prior or current definite colonic dysplasia except low-grade dysplasia that has been completely removed
- Major surgery within 3 months before screening or planned major surgery during the study
- Received protocol-specified prohibited medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive MK-8690 or placebo via subcutaneous injection to evaluate efficacy and safety for ulcerative colitis.
Weekly visits for up to 12 weeks
Duration - 12 weeks
Participants who do not respond to initial treatment receive MK-8690 via subcutaneous injection for an additional 12 weeks.
Weekly visits for up to 12 weeks
Duration - Up to approximately 42 weeks
Participants who respond to treatment receive additional MK-8690 via subcutaneous injection for up to approximately 42 weeks.
Visits approximately every 4 weeks
Trial Site Locations
Total: 8 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
Tulane University School of Medicine ( Site 1073)
New Orleans, Louisiana, United States, 70112
Actively Recruiting
8
BVL Research - Kansas ( Site 1054)
Liberty, Missouri, United States, 64068
Actively Recruiting
Research Team
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Toll Free Number
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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