MK-8690 for moderately to severely active ulcerative colitis
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
PHASE2 · Merck Sharp & Dohme LLC · NCT07463183
This trial will test whether the investigational drug MK-8690 can help adults with moderate to severe ulcerative colitis reach clinical remission by week 12.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC (industry) |
| Locations | 7 sites (Anaheim, California and 6 other locations) |
| Trial ID | NCT07463183 on ClinicalTrials.gov |
What this trial studies
This is a Phase 2, randomized, placebo-controlled trial comparing MK-8690 to placebo in participants with moderately to severely active ulcerative colitis. The primary endpoint is the proportion of participants achieving clinical remission per the Modified Mayo Score at Week 12. Eligible participants must have had UC for at least 3 months, weigh ≥40 kg, and meet prior-treatment failure, intolerance, or steroid-dependence criteria, while key exclusions include Crohn's disease, fulminant colitis, toxic megacolon, or UC limited to the rectum. Participants will be treated and followed at selected U.S. clinical sites with protocol-specified drug stabilization requirements before and during the study.
Who should consider this trial
Good fit: Adults with moderately to severely active ulcerative colitis of at least 3 months' duration who weigh ≥40 kg and have had inadequate response, loss of response, intolerance to prior UC therapies, or corticosteroid dependence are the intended participants.
Not a fit: Patients with Crohn's disease, indeterminate colitis, fulminant colitis or toxic megacolon, UC limited to the rectum, or other conditions that would confound efficacy assessment are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, MK-8690 could offer a new oral treatment option that helps more patients achieve remission more quickly.
How similar studies have performed: Other oral small-molecule and biologic treatments have shown benefit in ulcerative colitis, but MK-8690 is an investigational agent with limited published data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Anaheim, California and 6 other locations
- Clinnova Research ( Site 1042) — Anaheim, 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)
- Gastroenterology Associates of Central Georgia ( Site 1060) — Macon, Georgia, United States (RECRUITING)
- BVL Research - Kansas ( Site 1054) — Liberty, Missouri, United States (RECRUITING)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colitis Ulcerative, Ulcerative Colitis