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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMerck Sharp & Dohme LLC

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MK-8690
  • Placebo

Treatment groups

100 Participants
are divided into 4 treatment groups

Locations

11
South Korea
Wonju Severance Christian Hospital ( Site 1602)26426, WŏnjuKang-won-do, South Korea
Kangbuk Samsung Hospital ( Site 1601)03181, Seoul South Korea
United States
California
Clinnova Research ( Site 1042)92805, Anaheim United States
Colorado
Peak Gastroenterology Associates ( Site 1052)80907, Colorado Springs United States

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor