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NCT07463183PHASE2Recruiting

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

Merck Sharp & Dohme LLC

Start Date

3/24/2026

Completion Date

12/21/2028

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 Criteria

Age Range: 18 years to 75 years

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

Interventions

DRUG

MK-8690

OTHER

Placebo

Interested in This Trial?

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Conditions

Colitis UlcerativeUlcerative Colitis

Locations

Clinnova Research ( Site 1042)

Anaheim, California 92805

United States

Southern California Research Center ( Site 1044)

Coronado, California 92118

United States

Peak Gastroenterology Associates ( Site 1052)

Colorado Springs, Colorado 80907

United States

South Denver Gastroenterology, PC ( Site 1068)

Englewood, Colorado 80113

United States

Nature Coast Clinical Research ( Site 1045)

Inverness, Florida 34452

United States

Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)

Miami, Florida 33134

United States

AdventHealth Orlando ( Site 1074)

Orlando, Florida 32803

United States

Gastroenterology Associates of Central Georgia ( Site 1060)

Macon, Georgia 31201

United States

University of Kansas Medical Center ( Site 1077)

Kansas City, Kansas 66160

United States

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

New Orleans, Louisiana 70112

United States

BVL Research - Kansas ( Site 1054)

Liberty, Missouri 64068

United States

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

Lethbridge, Alberta T1J 4G9

Canada

Toronto Western Hospital ( Site 1006)

Toronto, Ontario M5T 2S8

Canada

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

Montreal, Quebec H2X 0C1

Canada

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

Medellín, Antioquia 050001

Colombia

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

Barranquilla, Atlántico 080020

Colombia

Fundacion Santa Fe de Bogota ( Site 1165)

Bogota, Cundinamarca 110111

Colombia

Fundación Valle del Lili ( Site 1162)

Cali, Valle del Cauca Department 760032

Colombia

Centre Hospitalier Dr Schaffner ( Site 1288)

Lens, Pas-de-Calais 62300

France

Clinique Jules Verne ( Site 1284)

Nantes, Pays de la Loire Region 44300

France

Universitaetsklinikum Ulm. ( Site 1324)

Ulm, Baden-Wurttemberg 89081

Germany

Evangelismos General Hospital of Athens ( Site 1362)

Athens, Attica 10676

Greece

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

Athens, Attica 115 27

Greece

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

Bologna, Emilia-Romagna 40138

Italy

Radboudumc ( Site 1650)

Nijmegen, Gelderland 6525 GA

Netherlands

Amsterdam UMC, locatie VUmc ( Site 1651)

Amsterdam, North Holland 1081 HZ

Netherlands

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

Krakow, Lesser Poland Voivodeship 31-513

Poland

Melita Medical Sp Zoo ( Site 1442)

Wroclaw, Lower Silesian Voivodeship 53-611

Poland

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

Warsaw, Masovian Voivodeship 00-189

Poland

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

Warsaw, Masovian Voivodeship 04-501

Poland

Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1450)

Szczecin, West Pomeranian Voivodeship 71-434

Poland

Wonju Severance Christian Hospital ( Site 1602)

Wŏnju, Kang-won-do 26426

South Korea

Korea University Ansan Hospital ( Site 1603)

Ansan-si, Kyonggi-do 15355

South Korea

Kangbuk Samsung Hospital ( Site 1601)

Seoul, 03181

South Korea

Addenbrooke's Hospital ( Site 1525)

Cambridge, Cambridgeshire CB2 0QQ

United Kingdom

Fairfield General Hospital ( Site 1524)

Bury, Lancashire BL9 7TD

United Kingdom

Guys and St Thomas NHS Foundation Trust ( Site 1523)

London, London, City of SE1 9RT

United Kingdom

Huddersfield Royal Infirmary ( Site 1522)

Huddersfield, York HD3 3EA

United Kingdom