Tests MK-8690 for moderately to severely active ulcerative colitis
Tests MK-8690 against placebo in adults with active ulcerative colitis.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Anaheim, Colorado Springs, Coronado, Englewood, Inverness, Kansas City, Liberty, Macon, Miami, New Orleans, and Orlando, United StatesSee the 11 sitesAlso in 11 other countries, 35 sites
- Trial code
- NCT07463183
- EU 2025-523479-49-00
- U1111-1326-7763
- Registry title
- A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 100 people, planned
- Started
- 24 Mar 2026
- Expected to end
- 21 Dec 2028
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- MK-8690
- Placebo
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with ulcerative colitis that is moderately to severely active. It tests the drug MK-8690 against a placebo.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Moderately to severely active ulcerative colitis, present for at least 3 months before randomization. Weight of at least 40 kg (88 lb).
- Earlier treatment
- Must have had at least 1 of these: an inadequate response or loss of response to 1 or more protocol-specified treatments, protocol-specified corticosteroid dependence, or intolerance to 1 or more protocol-specified UC treatments. Must be on protocol-specified drugs during the study and meet drug stabilization requirements, as applicable.
Main reasons for not taking part
- Crohn's disease, indeterminate colitis or other types of colitis or enteritis that may confound efficacy assessment
- Fulminant colitis or toxic megacolon
- Ulcerative colitis limited to the rectum
- Known infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
- Total proctocolectomy or partial colectomy, or a current or impending need for colostomy or ileostomy
The registry criteria, word for word
Show all 19 criteriaShow less
Other 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
Check if you might fit
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?
Where in United States
Also in 11 other countries, 35 sites
- Clinnova Research (Site 1042)Anaheim, United StatesContact: Study CoordinatorTaking people
- Peak Gastroenterology Associates (Site 1052)Colorado Springs, United StatesContact: Study CoordinatorTaking people
- Southern California Research Center (Site 1044)Coronado, United StatesContact: Study CoordinatorTaking people
- South Denver Gastroenterology, PC (Site 1068)Englewood, United StatesContact: Study CoordinatorTaking people
- Nature Coast Clinical Research (Site 1045)Inverness, United StatesContact: Study CoordinatorTaking people
- University of Kansas Medical Center (Site 1077)Kansas City, United StatesContact: Study CoordinatorTaking people
- BVL Research - Kansas (Site 1054)Liberty, United StatesContact: Study CoordinatorTaking people
- Gastroenterology Associates of Central Georgia (Site 1060)Macon, United StatesContact: Study CoordinatorTaking people
- Research Associates of South Florida - Miami - Southwest 8th Street (Site 1072)Miami, United StatesContact: Study CoordinatorTaking people
- Tulane University School of Medicine-Gastroenterology and Hepatology (Site 1073)New Orleans, United StatesContact: Study CoordinatorTaking people
- AdventHealth Orlando (Site 1074)Orlando, United StatesContact: Study CoordinatorTaking people
About the trial
What the trial wants to find out
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 4 groups in the trial
- Period 1: MK-8690Treatment being tested
Participants will receive MK-8690 via subcutaneous injection for 12 weeks.
Treatment: MK-8690
- Period 1: PlaceboPlacebo, for comparison
Participants will receive placebo via subcutaneous injection for 12 weeks.
Treatment: Placebo
- Period 2: MK-8690Treatment being tested
Participants who do not respond to treatment in Period 1 (regardless of treatment assignment in Period 1) will receive MK-8690 via subcutaneous injection for 12 weeks.
Treatment: MK-8690
- Period 3: MK-8690Treatment being tested
Participants who respond to treatment in either Period 1 or Period 2 will receive additional MK-8690 via subcutaneous injection for up to approximately 42 weeks.
Treatment: MK-8690
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- Tests MK-8690 for moderately to severely active ulcerative colitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07463183, who can take part
- Record updated
- 12 November 2026