Recruiting
Phase 2

MK-8690

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07463183

Conditions

Colitis Ulcerative

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MK-8690

Placebo

Study Details

Brief 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.

Conditions

Colitis Ulcerative

Ulcerative Colitis

Study ID

NCT07463183

Start date

Mar 24, 2026

Status verified date

Aug, 2026

Completion date

Dec 21, 2028

Anticipated

Primary completion date

Oct 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 applicable

The main 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
  • Has UC exacerbation requiring hospitalization within 2 weeks before Screening
  • Has any active infection as specified in the protocol
  • Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
  • Has evidence of active tuberculosis (TB) or meets TB exclusionary parameters
  • Has a history of cancer (except fully treated nonmelanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before Randomization or has a history of colorectal cancer at any time
  • Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
  • Has had major surgery within 3 months before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study
  • Has received protocol-specified prohibited medications

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

MK-8690

Solution for subcutaneous injection

Placebo

Solution for subcutaneous injection

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Clinnova Research ( Site 1042)

Recruiting

Anaheim, California, United States, 92805

Contacts

Study Coordinator

949-889-0249

Southern California Research Center ( Site 1044)

Recruiting

Coronado, California, United States, 92118

Contacts

Study Coordinator

619-522-0330

Peak Gastroenterology Associates ( Site 1052)

Recruiting

Colorado Springs, Colorado, United States, 80907

Contacts

Study Coordinator

719-636-1201

South Denver Gastroenterology, PC ( Site 1068)

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Study Coordinator

303-406-4288

Nature Coast Clinical Research ( Site 1045)

Recruiting

Inverness, Florida, United States, 34452

Contacts

Study Coordinator

352-341-2100

Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)

Recruiting

Miami, Florida, United States, 33134

Contacts

Study Coordinator

786-476-8790

Gastroenterology Associates of Central Georgia ( Site 1060)

Recruiting

Macon, Georgia, United States, 31201

Contacts

Study Coordinator

478-464-2600

University of Kansas Medical Center ( Site 1077)

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Study Coordinator

913-588-6019

Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 1073)

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Study Coordinator

504-988-5110

BVL Research - Kansas ( Site 1054)

Recruiting

Liberty, Missouri, United States, 64068

Contacts

Study Coordinator

816-222-4241

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-31.