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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)
100 patients around the world
Available in Colombia, United States
Merck Sharp & Dohme LLC
4Research sites
100Patients around the world
This study is for people with
Ulcerative colitis
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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.
Sites
Salud SURA Industriales
Recruiting
Fundación Santa Fe de Bogotá
Recruiting
Clínica de la Costa - Barranquilla
Recruiting
Fundación Valle del Lili - Colombia
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Ulcerative colitis
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07463183
