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RECRUITING

NCT07463183

PHASE2

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-03-24

Completion Date

2028-12-21

Last Updated

2026-09-28

Healthy Volunteers

Conditions

Colitis Ulcerative Ulcerative Colitis

Interventions

DRUG

MK-8690

Solution for subcutaneous injection

OTHER

Placebo

Solution for subcutaneous injection

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

Locations (38)

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

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