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Набира участници Фаза 2 NCT07463183

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Colitis Ulcerative Ulcerative Colitis

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Интервенции
MK-8690
DRUG
Placebo
OTHER
Места на провеждане 7
САЩ (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
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
24.03.2026
Крайна дата
21.12.2028
Регистрационен номер
NCT07463183
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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