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

RecruitingPhase 2Ages 18 Years - 75 YearsAllMerck Sharp & Dohme LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ40 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
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What it tests

  • MK-8690
  • Placebo
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Where

39 sites
Clinnova Research ( Site 1042)
Anaheim, United States
Southern California Research Center ( Site 1044)
Coronado, United States
Peak Gastroenterology Associates ( Site 1052)
Colorado Springs, United States
South Denver Gastroenterology, PC ( Site 1068)
Englewood, United States
Nature Coast Clinical Research ( Site 1045)
Inverness, United States
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)
Miami, United States
AdventHealth Orlando ( Site 1074)
Orlando, United States
Gastroenterology Associates of Central Georgia ( Site 1060)
Macon, United States

โ€ฆand 31 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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