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
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Clinnova Research ( Site 1042)
RECRUITING
Anaheim
Southern California Research Center ( Site 1044)
RECRUITING
Coronado
Colorado
Peak Gastroenterology Associates ( Site 1052)
RECRUITING
Colorado Springs
South Denver Gastroenterology, PC ( Site 1068)
RECRUITING
Englewood
Florida
Nature Coast Clinical Research ( Site 1045)
RECRUITING
Inverness
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)
RECRUITING
Miami
Georgia
Gastroenterology Associates of Central Georgia ( Site 1060)
RECRUITING
Macon
Kansas
University of Kansas Medical Center ( Site 1077)
RECRUITING
Kansas City
Louisiana
Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073)
RECRUITING
New Orleans
Missouri
BVL Research - Kansas ( Site 1054)
RECRUITING
Liberty
Other Locations
Colombia
Clinica de la Costa S.A.S. ( Site 1161)
RECRUITING
Barranquilla
Fundacion Santa Fe de Bogota ( Site 1165)
RECRUITING
Bogota
Fundación Valle del Lili ( Site 1162)
RECRUITING
Cali
Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellín ( Site 1163)
RECRUITING
Medellín
France
Centre Hospitalier Dr Schaffner ( Site 1288)
RECRUITING
Lens
Clinique Jules Verne ( Site 1284)
RECRUITING
Nantes
Greece
Evangelismos General Hospital of Athens ( Site 1362)
RECRUITING
Athens
THORACIC GENERAL HOSPITAL OF ATHENS I SOTIRIA ( Site 1361)
RECRUITING
Athens
Netherlands
Amsterdam UMC, locatie VUmc ( Site 1651)
RECRUITING
Amsterdam
Radboudumc ( Site 1650)
RECRUITING
Nijmegen
Poland
PROMED P. LACH R. GLOWACKI SP. J. ( Site 1447)
RECRUITING
Krakow
Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1450)
RECRUITING
Szczecin
EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1449)
RECRUITING
Warsaw
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś ( Site 1448)
RECRUITING
Warsaw
Melita Medical Sp Zoo ( Site 1442)
RECRUITING
Wroclaw
Republic of Korea
Korea University Ansan Hospital ( Site 1603)
RECRUITING
Ansan-si
Kangbuk Samsung Hospital ( Site 1601)
RECRUITING
Seoul
Wonju Severance Christian Hospital ( Site 1602)
RECRUITING
Wŏnju
United Kingdom
Fairfield General Hospital ( Site 1524)
RECRUITING
Bury
Huddersfield Royal Infirmary ( Site 1522)
RECRUITING
Huddersfield
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-03-24
Estimated Completion Date: 2028-12-21
Participants
Target number of participants: 100
Treatments
Experimental: Period 1: MK-8690
Participants will receive MK-8690 via subcutaneous injection for 12 weeks.
Placebo_comparator: Period 1: Placebo
Participants will receive placebo via subcutaneous injection for 12 weeks.
Experimental: Period 2: MK-8690
Participants who do not respond to treatment in Period 1 (regardless of treatment assignment in Period 1) will receive MK-8690 via subcutaneous injection for 12 weeks.
Experimental: Period 3: MK-8690
Participants who respond to treatment in either Period 1 or Period 2 will receive additional MK-8690 via subcutaneous injection for up to approximately 42 weeks.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC