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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2

Conditions: Colitis Ulcerative; Ulcerative Colitis

Treatments: Drug: MK-8690; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07463183

MK-8690-002 (Other Identifier)

8690-002

U1111-1326-7763 (Registry Identifier)

2025-523479-49-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 4 patient groups, including a placebo group

Period 1: MK-8690

Experimental group

Description:

Participants will receive MK-8690 via subcutaneous injection for 12 weeks.

Treatment:

Drug: MK-8690

Period 1: Placebo

Placebo Comparator group

Description:

Participants will receive placebo via subcutaneous injection for 12 weeks.

Treatment:

Other: Placebo

Period 2: MK-8690

Experimental group

Description:

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.

Treatment:

Drug: MK-8690

Period 3: MK-8690

Experimental group

Description:

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.

Treatment:

Drug: MK-8690