A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
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
- Colitis Ulcerative
- Ulcerative Colitis
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
New Orleans, Louisiana 70112
Study Coordinator
504-988-5110
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC