A Study to Evaluate the Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis
General Information:
The purpose of this Phase 2a study is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis.
Eligibility:
Inclusion criteria
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: Have had an inadequate response or loss of response to 1 or more protocol-specified treatments; protocol specified corticosteroid dependence; have 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
Exclusion criteria
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
There are additional requirements that determine if you may qualify to be in this study, which the study doctor will discuss with you.
Study Details:
Study description/explanation of participation:
This is a Phase 2a randomized, double-blind, placebo-controlled study. The purpose of this study 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.
Possible risks and side effects:
Please note that people may or may not directly benefit from being in a clinical trial. Being in a clinical trial is voluntary, and you are free to leave at any time for any reason. Your personal information will stay private throughout the clinical trial. The study doctor can answer any questions you may have, including those related to potential risks and benefits of participation.