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Recruiting Phase 2 NCT07463183

A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)

Phase 2 – studying effectiveness and dosage
Conditions: Colitis Ulcerative Ulcerative Colitis

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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 participate
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
Interventions
MK-8690
DRUG
Placebo
OTHER
Locations 7
United States (7)
Clinnova Research ( Site 1042)
Anaheim , California
Study Coordinator
Peak Gastroenterology Associates ( Site 1052)
Colorado Springs , Colorado
Study Coordinator
South Denver Gastroenterology, PC ( Site 1068)
Englewood , Colorado
Study Coordinator
Nature Coast Clinical Research ( Site 1045)
Inverness , Florida
Study Coordinator
BVL Research - Kansas ( Site 1054)
Liberty , Missouri
Study Coordinator
Gastroenterology Associates of Central Georgia ( Site 1060)
Macon , Georgia
Study Coordinator
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)
Miami , Florida
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
24.03.2026
Completion date
21.12.2028
Registry ID
NCT07463183
Source
clinicaltrials.gov
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