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Tests treatment safety and results for Colitis Ulcerative
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 medicine, given as an injection under the skin, being studied as a potential treatment for colitis ulcerative.
Also referred to as PRA052.
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 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.
- 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
- The main 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...
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- The main 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...
- Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable The main
- 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 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's taking place
- Anaheim, California, United States
- Colorado Springs, Colorado, United States
- Englewood, Colorado, United States
- Inverness, Florida, United States
- Miami, Florida, United States
- Macon, Georgia, United States
- Kansas City, Kansas, United States
- New Orleans, Louisiana, United States
- Liberty, Missouri, United States
- Nijmegen, Gelderland, Netherlands
- Wŏnju, Kang-won-do, South Korea
- Ansan-si, Kyonggi-do, South Korea
- Seoul, South Korea
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 - 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?
Study sites include Anaheim, California, United States; Colorado Springs, Colorado, United States; Englewood, Colorado, United States; Inverness, Florida, United States; Miami, Florida, United States; Macon, Georgia, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.