Colitis Ulcerative study: MK-8690
Official title A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
ClinicalTrials.gov ID: NCT07463183
What this study is testing
What is MK-8690?
MK-8690 is an investigational once‑daily subcutaneous injection being studied for ulcerative colitis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to determine whether MK-8690 can help patients reach clinical remission by week 12, compared to placebo.
- Who it's for
- Adults with moderately to severely active ulcerative colitis.
- What's involved
- Participants will receive either MK-8690 or a placebo and will be evaluated for remission using the Modified Mayo Score.
- Time commitment
- The study lasts 12 weeks, with scheduled visits to monitor progress.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
- Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable The main
You likely can't join if
- Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis...
- 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
See the full eligibility criteria
- 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
- Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable The main
- 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 how well it works 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Anaheim, California, United States
- Coronado, California, United States
- Colorado Springs, Colorado, United States
- Englewood, Colorado, United States
- Inverness, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Macon, Georgia, United States
- Kansas City, Kansas, United States
- New Orleans, Louisiana, United States
- Liberty, Missouri, United States
- Lethbridge, Alberta, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Concepción, Biobio, Chile
- Santiago, Region M. de Santiago, Chile
- Medellín, Antioquia, Colombia
- Barranquilla, Atlántico, Colombia
- Bogota, Cundinamarca, Colombia
- Cali, Valle del Cauca Department, Colombia
+ 20 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anaheim, California, United States; Coronado, California, United States; Colorado Springs, Colorado, United States; Englewood, Colorado, United States; Inverness, Florida, United States; Miami, Florida, United States and 34 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.