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

Part of paid clinical trials in Anaheim, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07463183
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MK-8690 — DRUG
    Solution for subcutaneous injection
  • Placebo — OTHER
    Solution for subcutaneous injection

Study Details

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.

Key Dates

Start date
Mar 24, 2026
Status verified
May 2026
Primary completion
Oct 28, 2027
Completion
Dec 21, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12 [ Time Frame: Week 12 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Clinnova Research ( Site 1042)AnaheimCalifornia92805
Study Coordinator
949-889-0249
Peak Gastroenterology Associates ( Site 1052)Colorado SpringsColorado80907
Study Coordinator
719-636-1201
South Denver Gastroenterology, PC ( Site 1068)EnglewoodColorado80113
Study Coordinator
303-406-4288
Nature Coast Clinical Research ( Site 1045)InvernessFlorida34452
Study Coordinator
352-341-2100
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)MiamiFlorida33134
Study Coordinator
786-476-8790
Gastroenterology Associates of Central Georgia ( Site 1060)MaconGeorgia31201
Study Coordinator
478-464-2600
Tulane University School of Medicine ( Site 1073)New OrleansLouisiana70112
Study Coordinator
504-988-5110
BVL Research - Kansas ( Site 1054)LibertyMissouri64068
Study Coordinator
816-222-4241

Find similar trials in Anaheim, CA

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Clinnova Research· Anaheim, CAPeak Gastroenterology Associates· Colorado Springs, COSouth Denver Gastroenterology, PC· Englewood, CONature Coast Clinical Research· Inverness, FLResearch Associates of South Florida - Miami - Southwest 8th Street· Miami, FLGastroenterology Associates of Central Georgia· Macon, GA

Related Studies