100 Participants NeededMy employer runs this trial

MK-8690 for Ulcerative Colitis

Recruiting at 35 trial locations
TF
Overseen ByToll Free Number
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new treatment, MK-8690, for individuals with moderately to severely active ulcerative colitis, a condition that causes inflammation and sores in the colon. The study aims to determine if this treatment can help patients achieve clinical remission (a period where symptoms are reduced or gone) more effectively than a placebo over 12 weeks. Participants will receive injections of either MK-8690 or a placebo, with options for additional treatment periods based on their response. Those who have had ulcerative colitis for at least three months and have not responded well to other treatments might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, it mentions that participants must be on treatment with certain drugs during the study and meet stabilization requirements, so you might need to continue some medications.

Is there any evidence suggesting that MK-8690 is likely to be safe for humans?

Research has shown that MK-8690 has a safety profile similar to a placebo in clinical studies. This indicates that the treatment's side effects resemble those of a harmless substance, suggesting it is generally well-tolerated. Although researchers continue to study MK-8690 for its effects on ulcerative colitis, this information offers some reassurance about its safety in humans.12345

Why do researchers think this study treatment might be promising for ulcerative colitis?

Most treatments for ulcerative colitis, like mesalamine and corticosteroids, work by reducing inflammation broadly in the colon. But MK-8690 works differently, targeting specific pathways involved in the inflammatory process, potentially leading to more precise treatment with fewer side effects. Researchers are excited because MK-8690 is delivered via subcutaneous injection, offering an alternative for patients who struggle with oral medications. This targeted approach could mean more effective management of ulcerative colitis symptoms and improved patient outcomes.

What evidence suggests that MK-8690 might be an effective treatment for ulcerative colitis?

Research has shown that MK-8690 targets a specific protein involved in inflammation, potentially reducing inflammation in people with ulcerative colitis. Early results suggest it could help manage symptoms in moderate to severe cases. Although limited data from human studies exist, the mechanism of this treatment shows promise for controlling ulcerative colitis. This trial will evaluate the effectiveness of MK-8690, with participants receiving either MK-8690 or a placebo initially, followed by additional treatment periods based on their response. Further studies are underway to confirm its effectiveness.12345

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for people aged 40 kg or more who have had moderately to severely active ulcerative colitis for at least 3 months and haven't responded well, lost response, or can't tolerate standard treatments. People with certain infections, other bowel diseases, recent major surgery, or some cancer histories cannot join.

Inclusion Criteria

I have not responded, lost response, or cannot tolerate at least one required UC treatment.
I am taking the required study drugs and my condition is stable on them.
I have had ulcerative colitis for at least 3 months.
See 2 more

Exclusion Criteria

I do not have any active infections right now.
I have Crohn's disease, indeterminate colitis, or another type of colitis or enteritis.
My ulcerative colitis is only in my rectum.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive MK-8690 or placebo via subcutaneous injection for 12 weeks

12 weeks

Treatment Period 2

Participants who do not respond to treatment in Period 1 receive MK-8690 via subcutaneous injection for 12 weeks

12 weeks

Treatment Period 3

Participants who respond to treatment in either Period 1 or Period 2 receive additional MK-8690 via subcutaneous injection for up to approximately 42 weeks

42 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MK-8690

Trial Overview

The study compares a new drug called MK-8690 to a placebo (inactive treatment) in people with moderate to severe ulcerative colitis. Participants are randomly assigned to receive either MK-8690 or placebo for 12 weeks to see if the drug helps achieve remission.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Period 3: MK-8690Experimental Treatment1 Intervention
Group II: Period 2: MK-8690Experimental Treatment1 Intervention
Group III: Period 1: MK-8690Experimental Treatment1 Intervention
Group IV: Period 1: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

A Study to Evaluate Efficacy and Safety of MK-8690 in ...

The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis.

A Study to Evaluate Efficacy and Safety of MK-8690 in ...

The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis.

MK-8690: Uses, Side Effects, Dosing & 1 Clinical Trials

This Phase 2 study, sponsored by Merck Sharp & Dohme LLC, is designed to evaluate the efficacy and safety of MK-8690 in individuals diagnosed ...

MK-8690 for Ulcerative Colitis

The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis.

MK-8690 / Dr Falk, Merck (MSD)

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