A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
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
4 other identifiers
interventional
100
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2026
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 11, 2026
CompletedStudy Start
First participant enrolled
March 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 21, 2028
June 12, 2026
June 1, 2026
1.6 years
March 4, 2026
June 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1 with no friability, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Week 12
Secondary Outcomes (6)
Percentage of Participants With One or More Adverse Events (AEs)
Up to approximately 12 months
Percentage of Participants Who Discontinued Study Intervention Due to an AE
Up to approximately 12 months
Percentage of Participants Achieving Clinical Response Per MMS at Week 12
Week 12
Percentage of Participants With Endoscopic Improvement at Week 12
Week 12
Percentage of Participants Achieving Clinical Remission Per Partial Modified Mayo Score (pMMS) at Week 12
Week 12
- +1 more secondary outcomes
Study Arms (4)
Period 1: MK-8690
EXPERIMENTALParticipants will receive MK-8690 via subcutaneous injection for 12 weeks.
Period 1: Placebo
PLACEBO COMPARATORParticipants will receive placebo via subcutaneous injection for 12 weeks.
Period 2: MK-8690
EXPERIMENTALParticipants 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.
Period 3: MK-8690
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Clinnova Research ( Site 1042)
Anaheim, California, 92805, United States
Peak Gastroenterology Associates ( Site 1052)
Colorado Springs, Colorado, 80907, United States
South Denver Gastroenterology, PC ( Site 1068)
Englewood, Colorado, 80113, United States
Nature Coast Clinical Research ( Site 1045)
Inverness, Florida, 34452, United States
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)
Miami, Florida, 33134, United States
Gastroenterology Associates of Central Georgia ( Site 1060)
Macon, Georgia, 31201, United States
University of Kansas Medical Center ( Site 1077)
Kansas City, Kansas, 66160, United States
Tulane University School of Medicine ( Site 1073)
New Orleans, Louisiana, 70112, United States
BVL Research - Kansas ( Site 1054)
Liberty, Missouri, 64068, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Period 1 is double-blind. Period 2 and Period 3 are open-label.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2026
First Posted
March 11, 2026
Study Start
March 24, 2026
Primary Completion (Estimated)
October 28, 2027
Study Completion (Estimated)
December 21, 2028
Last Updated
June 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf