A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
Recruiting · NCT07463183 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
MK-8690Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
32 locations listed across 7 US states.
- 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
- 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
- Kangbuk Samsung Hospital ( Site 1601) - Seoul, South Korea
- Prairie Institute of Liver and Luminal Advanced Research ( Site 1008) - Lethbridge, Alberta, 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
- Evangelismos General Hospital of Athens ( Site 1362) - Athens, Attica, Greece
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1361) - Athens, Attica, Greece
- Fundacion Santa Fe de Bogota ( Site 1165) - Bogota, Cundinamarca, Colombia
- Radboudumc ( Site 1650) - Nijmegen, Gelderland, Netherlands
- Wonju Severance Christian Hospital ( Site 1602) - Wŏnju, Kang-won-do, South Korea
- Korea University Ansan Hospital ( Site 1603) - Ansan-si, Kyonggi-do, South Korea
- Fairfield General Hospital ( Site 1524) - Bury, Lancashire, United Kingdom
- 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
- Amsterdam UMC, locatie VUmc ( Site 1651) - Amsterdam, North Holland, Netherlands
- Centre Hospitalier Dr Schaffner ( Site 1288) - Lens, Pas-de-Calais, France
- Clinique Jules Verne ( Site 1284) - Nantes, Pays de la Loire Region, France
- Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1001) - Montreal, Quebec, Canada
- Fundación Valle del Lili ( Site 1162) - Cali, Valle del Cauca Department, Colombia
- Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1450) - Szczecin, West Pomeranian Voivodeship, Poland
- Huddersfield Royal Infirmary ( Site 1522) - Huddersfield, York, United Kingdom