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RecruitingPhase 2

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

A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Adult Participants With Moderately to Severely Active Ulcerative Colitis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well MK-8690 works and how safe it is for people with moderately to severely active ulcerative colitis, a disease that causes swelling and sores in the large bowel. It compares MK-8690 with a placebo, a treatment with no active drug, to see whether more people reach remission after 12 weeks. Remission means the disease has few or no symptoms.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had ulcerative colitis symptoms for at least 3 months before being assigned to a study group.
  • Have moderately to severely active ulcerative colitis.
  • Weigh at least 40 kg (about 88 pounds).
  • Have tried at least one treatment listed in the study that did not work well, stopped working, or caused side effects you could not tolerate; or need ongoing steroid treatment as defined by the study.
  • Meet the study’s rules for keeping doses steady if taking certain medicines during the study.

Who can't join

  • Have Crohn’s disease, bowel inflammation of an unclear type, or another type of bowel inflammation that could affect study results.
  • Have a very severe form of colitis, dangerous swelling of the large bowel, or ulcerative colitis only in the rectum (the last part of the large bowel).
  • Need or may soon need surgery to send stool into an outside bag, or have had part or all of the large bowel removed.
  • Had a colitis flare needing a hospital stay within 2 weeks before screening.
  • Have an active infection covered by the study rules, hepatitis B or C, HIV, active tuberculosis (TB), or other TB-related reasons for exclusion.
  • Have ever had cancer of the colon or rectum, or have been cancer-free for less than 5 years before study group assignment. Exceptions include fully treated nonmelanoma skin cancer and early cervical cancer completely removed by surgery.
  • Have or have had abnormal cells in the colon lining, unless the changes were low-grade and completely removed.
  • Had major surgery within 3 months before screening, plan surgery requiring you to be fully asleep during the study, or have taken medicines the study does not allow.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (11)

CA

CO

FL

GA

KS

LA

MO