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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07463183

Registry updated: 2026-10-23
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Description

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.

Interventions

  • MK-8690 (Drug)
    Solution for subcutaneous injection
  • Placebo (Other)
    Solution for subcutaneous injection

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

Conditions

Colitis Ulcerative Ulcerative Colitis

Locations

  • Clinnova Research ( Site 1042) — Anaheim, California, United States
  • Southern California Research Center ( Site 1044) — Coronado, California, United States
  • Peak Gastroenterology Associates ( Site 1052) — Colorado Springs, Colorado, United States
  • South Denver Gastroenterology, PC ( Site 1068) — Englewood, Colorado, United States
  • Nature Coast Clinical Research ( Site 1045) — Inverness, Florida, United States
  • Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072) — Miami, Florida, United States
  • AdventHealth Orlando ( Site 1074) — Orlando, Florida, United States
  • Gastroenterology Associates of Central Georgia ( Site 1060) — Macon, Georgia, United States
  • University of Kansas Medical Center ( Site 1077) — Kansas City, Kansas, United States
  • Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073) — New Orleans, Louisiana, United States
  • BVL Research - Kansas ( Site 1054) — Liberty, Missouri, United States
  • Prairie Institute of Liver and Luminal Advanced Research ( Site 1008) — Lethbridge, Alberta, Canada
  • Toronto Western Hospital ( Site 1006) — Toronto, Ontario, Canada
  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1001) — Montreal, Quebec, Canada
  • Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellín ( Site 1163) — Medellín, Antioquia, Colombia
  • Clinica de la Costa S.A.S. ( Site 1161) — Barranquilla, Atlántico, Colombia
  • Fundacion Santa Fe de Bogota ( Site 1165) — Bogota, Cundinamarca, Colombia
  • Fundación Valle del Lili ( Site 1162) — Cali, Valle del Cauca Department, Colombia
  • Centre Hospitalier Dr Schaffner ( Site 1288) — Lens, Pas-de-Calais, France
  • Clinique Jules Verne ( Site 1284) — Nantes, Pays de la Loire Region, France
  • Universitaetsklinikum Ulm. ( Site 1324) — Ulm, Baden-Wurttemberg, Germany
  • Universitätsklinikum Brandenburg an der Havel ( Site 1323) — Brandenburg, Germany
  • Evangelismos General Hospital of Athens ( Site 1362) — Athens, Attica, Greece
  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1361) — Athens, Attica, Greece
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1404) — Bologna, Emilia-Romagna, Italy
  • Radboudumc ( Site 1650) — Nijmegen, Gelderland, Netherlands
  • Amsterdam UMC, locatie VUmc ( Site 1651) — Amsterdam, North Holland, Netherlands
  • PROMED P. LACH R. GLOWACKI SP. J. ( Site 1447) — Krakow, Lesser Poland Voivodeship, Poland
  • Melita Medical Sp Zoo ( Site 1442) — Wroclaw, Lower Silesian Voivodeship, Poland
  • EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1449) — Warsaw, Masovian Voivodeship, Poland
  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś ( Site 1448) — Warsaw, Masovian Voivodeship, Poland
  • Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1450) — Szczecin, West Pomeranian Voivodeship, Poland
  • Wonju Severance Christian Hospital ( Site 1602) — Wŏnju, Kang-won-do, South Korea
  • Korea University Ansan Hospital ( Site 1603) — Ansan-si, Kyonggi-do, South Korea
  • Kangbuk Samsung Hospital ( Site 1601) — Seoul, South Korea
  • Addenbrooke's Hospital ( Site 1525) — Cambridge, Cambridgeshire, United Kingdom
  • Fairfield General Hospital ( Site 1524) — Bury, Lancashire, United Kingdom
  • Guys and St Thomas NHS Foundation Trust ( Site 1523) — London, London, City of, United Kingdom
  • Huddersfield Royal Infirmary ( Site 1522) — Huddersfield, York, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record