A Study of MK-8690 for Moderately to Severely Active Ulcerative Colitis

This study is testing a new treatment called MK-8690 for people with moderately to severely active ulcerative colitis (UC), a long-lasting inflammatory bowel disease. Researchers want to see if MK-8690, given as a shot under the skin, is better than a placebo (an inactive substance) at helping people achieve clinical remission (a period when symptoms are reduced or absent). You might be able to join if you are 18 to 75 years old, have had UC for at least 3 months, and your current UC treatment hasn't worked well enough. The study aims to enroll about 100 participants. The current status of this study is unclear.

Study design
This is an interventional study comparing MK-8690 to a placebo in approximately 100 participants. It is designed to see if MK-8690 is superior to placebo in achieving clinical remission.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at Week 12, which suggests follow-up for at least this duration.

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NCT07463183

A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Merck Sharp & Dohme LLC
~100 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:MK-8690Placebo

At a glance

Recruiting sites
28 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
Measured over Week 12
Colitis Ulcerative
Ulcerative Colitis
28 sites across 23 states
California2
Colorado2
Florida2
Attica2
Masovian Voivodeship2
Georgia1
Kansas1
Louisiana1
  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12Week 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.