Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07463183

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

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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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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