MK-8690 for moderately to severely active ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, placebo-controlled trial comparing MK-8690 to placebo in participants with moderately to severely active ulcerative colitis. The primary endpoint is the proportion of participants achieving clinical remission per the Modified Mayo Score at Week 12. Eligible participants must have had UC for at least 3 months, weigh ≥40 kg, and meet prior-treatment failure, intolerance, or steroid-dependence criteria, while key exclusions include Crohn's disease, fulminant colitis, toxic megacolon, or UC limited to the rectum. Participants will be treated and followed at selected U.S. clinical sites with protocol-specified drug stabilization requirements before and during the study.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinnova Research ( Site 1042)
  Anaheim, California, United States Recruiting
• Southern California Research Center ( Site 1044)
  Coronado, California, United States Recruiting
• Peak Gastroenterology Associates ( Site 1052)
  Colorado Springs, Colorado, United States Recruiting
• South Denver Gastroenterology, PC ( Site 1068)
  Englewood, Colorado, United States Recruiting
• Nature Coast Clinical Research ( Site 1045)
  Inverness, Florida, United States Recruiting
• Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Aletekitug safety study in moderate to severe ulcerative colitis

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• Treatment study to test multiple interventions for moderate to severe ulcerative colitis

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• A Probiotic Approach to Modulating Gut Microbiota in Mild-to-Moderate Ulcerative Colitis

  A specific probiotic given rectally will be tested in adults with mild-to-moderate ulcerative colitis to see if it can help manage symptoms.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.