Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants in Period 1 will have parallel assignment.
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Period 1 is double-blind. Period 2 and Period 3 are open-label.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Period 1: MK-8690
Participants will receive MK-8690 via subcutaneous injection for 12 weeks.
  • Drug: MK-8690
    Solution for subcutaneous injection
    Other names:
    • PRA052
Placebo Comparator
Period 1: Placebo
Participants will receive placebo via subcutaneous injection for 12 weeks.
  • Other: Placebo
    Solution for subcutaneous injection
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.
  • Drug: MK-8690
    Solution for subcutaneous injection
    Other names:
    • PRA052
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.
  • Drug: MK-8690
    Solution for subcutaneous injection
    Other names:
    • PRA052

Recruiting Locations

Clinnova Research ( Site 1042)
Anaheim, California 92805
Contact:
Study Coordinator
949-889-0249

Peak Gastroenterology Associates ( Site 1052)
Colorado Springs, Colorado 80907
Contact:
Study Coordinator
719-636-1201

South Denver Gastroenterology, PC ( Site 1068)
Englewood, Colorado 80113
Contact:
Study Coordinator
303-406-4288

Nature Coast Clinical Research ( Site 1045)
Inverness, Florida 34452
Contact:
Study Coordinator
352-341-2100

Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)
Miami, Florida 33134
Contact:
Study Coordinator
786-476-8790

Gastroenterology Associates of Central Georgia ( Site 1060)
Macon, Georgia 31201
Contact:
Study Coordinator
478-464-2600

BVL Research - Kansas ( Site 1054)
Liberty, Missouri 64068
Contact:
Study Coordinator
816-222-4241

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.