NCT07463183RecruitingPhase 2
A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 4 Mar 2026
- Start date
- 24 Mar 2026
- Primary completion date
- 28 Oct 2027
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Ulcerative colitis
- NCT number
- NCT07463183
- EU CT number
- 2025-523479-49-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 24 Mar 2026 to the primary completion date, 28 Oct 2027
- 44 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prairie Institute of Liver and Luminal Advanced Research ( Site 1008) Coordinator of this site? Confirm its status | Lethbridge | Canada | Recruiting |
| Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1001) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Toronto Western Hospital ( Site 1006) Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Clinica de la Costa S.A.S. ( Site 1161) Coordinator of this site? Confirm its status | Barranquilla | Colombia | Recruiting |
| Fundacion Santa Fe de Bogota ( Site 1165) Coordinator of this site? Confirm its status | Bogota | Colombia | Recruiting |
| Fundación Valle del Lili ( Site 1162) Coordinator of this site? Confirm its status | Cali | Colombia | Recruiting |
| Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellín ( Site 1163) Coordinator of this site? Confirm its status | Medellín | Colombia | Recruiting |
| Universitaetsklinikum Brandenburg an der Havel GmbH Coordinator of this site? Confirm its status | Brandenburg An Der Havel | Germany | Recruiting |
| Rostock University Medical Center Coordinator of this site? Confirm its status | Rostock | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Clinique des Cèdres Coordinator of this site? Confirm its status | Échirolles | France | Recruiting |
| Chorale Du Centre Hospitalier De Lens Coordinator of this site? Confirm its status | Lens | France | Recruiting |
| Clinique Jules Verne Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Fairfield General Hospital ( Site 1524) Coordinator of this site? Confirm its status | Bury | United Kingdom | Recruiting |
| Addenbrooke's Hospital ( Site 1525) Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| Huddersfield Royal Infirmary ( Site 1522) Coordinator of this site? Confirm its status | Huddersfield | United Kingdom | Recruiting |
| Guys and St Thomas NHS Foundation Trust ( Site 1523) Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Evangelismos S A Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Korea University Ansan Hospital ( Site 1603) Coordinator of this site? Confirm its status | Ansan-si | South Korea | Recruiting |
| Kangbuk Samsung Hospital ( Site 1601) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Wonju Severance Christian Hospital ( Site 1602) Coordinator of this site? Confirm its status | Wŏnju | South Korea | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Radboud universitair medisch centrum Stichting Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Promed P.Lach R.Glowacki Sp. j. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| Vivamed Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Eb Group Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Melita Medical Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Clinnova Research ( Site 1042) Coordinator of this site? Confirm its status | Anaheim | United States | Recruiting |
| Peak Gastroenterology Associates ( Site 1052) Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Southern California Research Center ( Site 1044) Coordinator of this site? Confirm its status | Coronado | United States | Recruiting |
| South Denver Gastroenterology, PC ( Site 1068) Coordinator of this site? Confirm its status | Englewood | United States | Recruiting |
| Nature Coast Clinical Research ( Site 1045) Coordinator of this site? Confirm its status | Inverness | United States | Recruiting |
| University of Kansas Medical Center ( Site 1077) Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| BVL Research - Kansas ( Site 1054) Coordinator of this site? Confirm its status | Liberty | United States | Recruiting |
| Gastroenterology Associates of Central Georgia ( Site 1060) Coordinator of this site? Confirm its status | Macon | United States | Recruiting |
| Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072) Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073) Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| AdventHealth Orlando ( Site 1074) Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.