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Clinical Trials in the USA / NCT07463183
Recruiting Phase 2

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

NCT07463183 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 2
Started
2026-03-24
Last updated
2026-09-09

Condition(s) studied

Colitis UlcerativeUlcerative Colitis

Investigational drug(s) / intervention(s)

MK-8690Placebo

MK-8690: Solution for subcutaneous injection

Placebo: Solution for subcutaneous injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
Clinnova Research ( Site 1042) Anaheim California Recruiting
Southern California Research Center ( Site 1044) Coronado California Recruiting
Peak Gastroenterology Associates ( Site 1052) Colorado Springs Colorado Recruiting
South Denver Gastroenterology, PC ( Site 1068) Englewood Colorado Recruiting
Nature Coast Clinical Research ( Site 1045) Inverness Florida Recruiting
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072) Miami Florida Recruiting
Gastroenterology Associates of Central Georgia ( Site 1060) Macon Georgia Recruiting
University of Kansas Medical Center ( Site 1077) Kansas City Kansas Recruiting
Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073) New Orleans Louisiana Recruiting
BVL Research - Kansas ( Site 1054) Liberty Missouri Recruiting
Prairie Institute of Liver and Luminal Advanced Research ( Site 1008) Lethbridge Alberta Recruiting
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1001) Montreal Quebec Recruiting
Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellín ( Site 1163) Medellín Antioquia Recruiting
Clinica de la Costa S.A.S. ( Site 1161) Barranquilla Atlántico Recruiting
Fundacion Santa Fe de Bogota ( Site 1165) Bogota Cundinamarca Recruiting
Fundación Valle del Lili ( Site 1162) Cali Valle del Cauca Department Recruiting
Centre Hospitalier Dr Schaffner ( Site 1288) Lens Pas-de-Calais Recruiting
Clinique Jules Verne ( Site 1284) Nantes Pays de la Loire Region Recruiting
Evangelismos General Hospital of Athens ( Site 1362) Athens Attica Recruiting
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1361) Athens Attica Recruiting
Radboudumc ( Site 1650) Nijmegen Gelderland Recruiting
Amsterdam UMC, locatie VUmc ( Site 1651) Amsterdam North Holland Recruiting
PROMED P. LACH R. GLOWACKI SP. J. ( Site 1447) Krakow Lesser Poland Voivodeship Recruiting
Melita Medical Sp Zoo ( Site 1442) Wroclaw Lower Silesian Voivodeship Recruiting
EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1449) Warsaw Masovian Voivodeship Recruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś ( Site 1448) Warsaw Masovian Voivodeship Recruiting
Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1450) Szczecin West Pomeranian Voivodeship Recruiting
Wonju Severance Christian Hospital ( Site 1602) Wŏnju Kang-won-do Recruiting
Korea University Ansan Hospital ( Site 1603) Ansan-si Kyonggi-do Recruiting
Kangbuk Samsung Hospital ( Site 1601) Seoul South Korea Recruiting
Fairfield General Hospital ( Site 1524) Bury Lancashire Recruiting
Huddersfield Royal Infirmary ( Site 1522) Huddersfield York Recruiting

More Merck Sharp & Dohme LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07463183 on ClinicalTrials.gov ↗ ← All trials in the USA