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NCT07463183From ClinicalTrials.govRecruiting

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

  • Colitis Ulcerative
  • Ulcerative Colitis

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
100
Started
24 March 2026
Main results due
28 October 2027
Study sites
38
Registry updated
28 September 2026

Can you take part?

  • Ages 18 years to 75 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(38)

  • 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

  • AdventHealth Orlando ( Site 1074)

    Orlando, Florida, United States

    Recruiting

  • Gastroenterology Associates of Central Georgia ( Site 1060)

    Macon, Georgia, United States

    Recruiting

  • University of Kansas Medical Center ( Site 1077)

    Kansas City, Kansas, United States

    Recruiting

  • Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073)

    New Orleans, Louisiana, United States

    Recruiting

  • BVL Research - Kansas ( Site 1054)

    Liberty, Missouri, United States

    Recruiting

  • Prairie Institute of Liver and Luminal Advanced Research ( Site 1008)

    Lethbridge, Alberta, Canada

    Recruiting

  • Toronto Western Hospital ( Site 1006)

    Toronto, Ontario, Canada

    Recruiting

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1001)

    Montreal, Quebec, Canada

    Recruiting

  • Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellín ( Site 1163)

    Medellín, Antioquia, Colombia

    Recruiting

  • Clinica de la Costa S.A.S. ( Site 1161)

    Barranquilla, Atlántico, Colombia

    Recruiting

  • Fundacion Santa Fe de Bogota ( Site 1165)

    Bogota, Cundinamarca, Colombia

    Recruiting

  • Fundación Valle del Lili ( Site 1162)

    Cali, Valle del Cauca Department, Colombia

    Recruiting

  • Centre Hospitalier Dr Schaffner ( Site 1288)

    Lens, Pas-de-Calais, France

    Recruiting

  • Clinique Jules Verne ( Site 1284)

    Nantes, Pays de la Loire Region, France

    Recruiting

  • Universitaetsklinikum Ulm. ( Site 1324)

    Ulm, Baden-Wurttemberg, Germany

    Recruiting

  • Evangelismos General Hospital of Athens ( Site 1362)

    Athens, Attica, Greece

    Recruiting

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1361)

    Athens, Attica, Greece

    Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1404)

    Bologna, Emilia-Romagna, Italy

    Recruiting

  • Radboudumc ( Site 1650)

    Nijmegen, Gelderland, Netherlands

    Recruiting

  • Amsterdam UMC, locatie VUmc ( Site 1651)

    Amsterdam, North Holland, Netherlands

    Recruiting

  • PROMED P. LACH R. GLOWACKI SP. J. ( Site 1447)

    Krakow, Lesser Poland Voivodeship, Poland

    Recruiting

  • Melita Medical Sp Zoo ( Site 1442)

    Wroclaw, Lower Silesian Voivodeship, Poland

    Recruiting

  • EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1449)

    Warsaw, Masovian Voivodeship, Poland

    Recruiting

  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś ( Site 1448)

    Warsaw, Masovian Voivodeship, Poland

    Recruiting

  • Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1450)

    Szczecin, West Pomeranian Voivodeship, Poland

    Recruiting

  • Wonju Severance Christian Hospital ( Site 1602)

    Wŏnju, Kang-won-do, South Korea

    Recruiting

  • Korea University Ansan Hospital ( Site 1603)

    Ansan-si, Kyonggi-do, South Korea

    Recruiting

  • Kangbuk Samsung Hospital ( Site 1601)

    Seoul, South Korea

    Recruiting

  • Addenbrooke's Hospital ( Site 1525)

    Cambridge, Cambridgeshire, United Kingdom

    Recruiting

  • Fairfield General Hospital ( Site 1524)

    Bury, Lancashire, United Kingdom

    Recruiting

  • Guys and St Thomas NHS Foundation Trust ( Site 1523)

    London, London, City of, United Kingdom

    Recruiting

  • Huddersfield Royal Infirmary ( Site 1522)

    Huddersfield, York, United Kingdom

    Recruiting

Showing 38 of 38 sites. 38 of the 38 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07463183. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerati | Trialion