A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Adult Participants With Moderately to Severely Active Ulcerative Colitis
Merck Sharp & Dohme LLC
Summary
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugMK-8690
Solution for subcutaneous injection
- OtherPlacebo
Solution for subcutaneous injection
Locations (7)
- Clinnova Research ( Site 1042)Anaheim, California
- Peak Gastroenterology Associates ( Site 1052)Colorado Springs, Colorado
- South Denver Gastroenterology, PC ( Site 1068)Englewood, Colorado
- Nature Coast Clinical Research ( Site 1045)Inverness, Florida
- Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)Miami, Florida
- Gastroenterology Associates of Central Georgia ( Site 1060)Macon, Georgia