A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
Phase 2 · Testing MK-8690 · 38 sites · Merck Sharp & Dohme LLC
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing MK-8690 (a drug) as a possible treatment. Condition(s) listed: Colitis Ulcerative and Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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…
- Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable
Plus 14 more requirement(s). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- The study has 4 groups.
- Start date: 2026-03-24.
- Main results expected around 2027-10-28 (estimate from the record).
- 38 study sites listed (38 marked recruiting) in Canada, Colombia, France, Germany and Greece and 6 more countries.
Groups in this study
- Period 1: MK-8690 (listed as: experimental group)
- Period 1: Placebo (listed as: placebo group)
- Period 2: MK-8690 (listed as: experimental group)
- Period 3: MK-8690 (listed as: experimental group)
Main thing being measured
- Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12 (Week 12)
In the researchers’ words
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.
Words you might see
- Placebo: a look-alike pill or injection with no active drug, used for comparison.
- Mayo score: a score used to measure how active ulcerative colitis is.
- Remission: a period when the disease is quiet or under control.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Colitis Ulcerative; Ulcerative Colitis |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Enrollment | 100 (estimated) |
| Start date | 2026-03-24 |
| Primary completion (est.) | 2027-10-28 |
| First posted | 2026-03-11 |
| Last updated | 2026-09-28 |
| 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 |
| ClinicalTrials.gov ID | NCT07463183 |
Interventions
- MK-8690 (Drug)
Solution for subcutaneous injection - Placebo (Other)
Solution for subcutaneous injection
Full eligibility criteria (from the record)
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)
Show all 38 sites
| Site | City | Country | Site status |
|---|---|---|---|
| Clinnova Research ( Site 1042) | Anaheim, California | United States | Recruiting |
| Southern California Research Center ( Site 1044) | Coronado, California | United States | Recruiting |
| Peak Gastroenterology Associates ( Site 1052) | Colorado Springs, Colorado | United States | Recruiting |
| South Denver Gastroenterology, PC ( Site 1068) | Englewood, Colorado | United States | Recruiting |
| Nature Coast Clinical Research ( Site 1045) | Inverness, Florida | United States | Recruiting |
| Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072) | Miami, Florida | United States | Recruiting |
| AdventHealth Orlando ( Site 1074) | Orlando, Florida | United States | Recruiting |
| Gastroenterology Associates of Central Georgia ( Site 1060) | Macon, Georgia | United States | Recruiting |
| University of Kansas Medical Center ( Site 1077) | Kansas City, Kansas | United States | Recruiting |
| Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073) | New Orleans, Louisiana | United States | Recruiting |
| BVL Research - Kansas ( Site 1054) | Liberty, Missouri | United States | Recruiting |
| Prairie Institute of Liver and Luminal Advanced Research ( Site 1008) | Lethbridge, Alberta | Canada | Recruiting |
| Toronto Western Hospital ( Site 1006) | Toronto, Ontario | Canada | Recruiting |
| Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1001) | Montreal, Quebec | Canada | Recruiting |
| Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellín ( Site 1163) | Medellín, Antioquia | Colombia | Recruiting |
| Clinica de la Costa S.A.S. ( Site 1161) | Barranquilla, Atlántico | Colombia | Recruiting |
| Fundacion Santa Fe de Bogota ( Site 1165) | Bogota, Cundinamarca | Colombia | Recruiting |
| Fundación Valle del Lili ( Site 1162) | Cali, Valle del Cauca Department | Colombia | Recruiting |
| Centre Hospitalier Dr Schaffner ( Site 1288) | Lens, Pas-de-Calais | France | Recruiting |
| Clinique Jules Verne ( Site 1284) | Nantes, Pays de la Loire Region | France | Recruiting |
| Universitaetsklinikum Ulm. ( Site 1324) | Ulm, Baden-Wurttemberg | Germany | Recruiting |
| Evangelismos General Hospital of Athens ( Site 1362) | Athens, Attica | Greece | Recruiting |
| THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1361) | Athens, Attica | Greece | Recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1404) | Bologna, Emilia-Romagna | Italy | Recruiting |
| Radboudumc ( Site 1650) | Nijmegen, Gelderland | Netherlands | Recruiting |
| Amsterdam UMC, locatie VUmc ( Site 1651) | Amsterdam, North Holland | Netherlands | Recruiting |
| PROMED P. LACH R. GLOWACKI SP. J. ( Site 1447) | Krakow, Lesser Poland Voivodeship | Poland | Recruiting |
| Melita Medical Sp Zoo ( Site 1442) | Wroclaw, Lower Silesian Voivodeship | Poland | Recruiting |
| EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1449) | Warsaw, Masovian Voivodeship | Poland | Recruiting |
| Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś ( Site 1448) | Warsaw, Masovian Voivodeship | Poland | Recruiting |
| Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1450) | Szczecin, West Pomeranian Voivodeship | Poland | Recruiting |
| Kangbuk Samsung Hospital ( Site 1601) | Seoul | South Korea | Recruiting |
| Wonju Severance Christian Hospital ( Site 1602) | Wŏnju, Kang-won-do | South Korea | Recruiting |
| Korea University Ansan Hospital ( Site 1603) | Ansan-si, Kyonggi-do | South Korea | Recruiting |
| Addenbrooke's Hospital ( Site 1525) | Cambridge, Cambridgeshire | United Kingdom | Recruiting |
| Fairfield General Hospital ( Site 1524) | Bury, Lancashire | United Kingdom | Recruiting |
| Guys and St Thomas NHS Foundation Trust ( Site 1523) | London, London, City of | United Kingdom | Recruiting |
| Huddersfield Royal Infirmary ( Site 1522) | Huddersfield, York | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.