What is the mechanism of action of this treatment?

Common treatments for Ulcerative Colitis (UC) include immunomodulatory agents, 5-aminosalicylic acid (5-ASA) medications, glucocorticoids, and tumor necrosis factor (TNF) inhibitors. Immunomodulatory agents like azathioprine and 6-mercaptopurine work by suppressing the immune system to reduce inflammation, which is crucial for preventing flare-ups and maintaining remission. 5-ASA medications, such as mesalamine, act locally in the colon to reduce inflammation and are effective in maintaining remission. Glucocorticoids like prednisone are used for their potent anti-inflammatory effects but are not suitable for long-term use due to side effects. TNF inhibitors, such as infliximab and adalimumab, target and neutralize TNF-alpha, a cytokine involved in systemic inflammation, providing rapid relief and long-term control of symptoms. These treatments are essential for managing UC as they help control inflammation, prevent complications, and improve the quality of life for patients.

What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include mesalamine, glucocorticoids, and immunomodulatory agents such as azathioprine and mercaptopurine. Mesalamine can cause side effects like nausea, headache, fever, rash, pancreatitis, and pneumonitis. Glucocorticoids, used for short-term induction therapy, may lead to systemic side effects such as adrenal suppression, increased infection risk, and osteoporosis with long-term use. Immunomodulatory agents like azathioprine and mercaptopurine can cause myelosuppression, hepatotoxicity, and increased susceptibility to infections. MK-6194, likely an immunomodulatory agent, may share similar side effects, including immunosuppression and potential liver toxicity.

What prior FDA approvals exist?

The FDA has approved several immunomodulatory agents for the treatment of Ulcerative Colitis. These include azathioprine and 6-mercaptopurine, which are thiopurines used to maintain remission in UC patients. Additionally, biologic agents such as anti-TNF agents (e.g., infliximab, adalimumab) and integrin receptor antagonists (e.g., vedolizumab) have been approved for moderate to severe UC. These treatments aim to modulate the immune response to reduce inflammation and maintain remission in UC patients.

What other types of research exist?

Promising novel alternatives to MK-6194 for Ulcerative Colitis patients include AJM300, an oral antagonist of α4 integrin, which has shown efficacy in a phase 2a study for patients with moderately active UC. Additionally, other biologics and small molecules targeting different pathways, such as vedolizumab (an integrin receptor antagonist) and ustekinumab (an IL-12/23 inhibitor), have also demonstrated effectiveness in UC treatment and may be considered as alternatives.

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Unknown

MK-6194 for Ulcerative Colitis

Phase 1

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No evidence of active tuberculosis (TB), latent TB, or inadequately treated TB

Mildly to severely active UC

Must not have

Prior treatment with recombinant IL-2 or modified IL-2 therapy, including MK-6194 (PT101)

Any uncontrolled or clinically significant concurrent systemic disease other than UC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 85 days

Summary

This trial tests a new drug called MK-6194 for people with active Ulcerative Colitis. It checks if the drug is safe, how it works in the body, and if it causes any immune reactions.

Who is the study for?

This trial is for adults with active Ulcerative Colitis (UC) who haven't responded well to at least one conventional therapy and no more than two advanced therapies. They must have had a recent colonoscopy if over 50 or at risk of colorectal cancer, not be planning surgery soon, and agree to use effective contraception. Exclusions include severe colitis symptoms, certain infections or treatments, history of other significant diseases like heart or lung problems, prior UC surgery, organ transplants, malignancy within the past five years except some skin cancers.

What is being tested?

The study tests MK-6194's safety and effectiveness in treating UC compared to a placebo. It will look into how the body processes the drug (pharmacokinetics), its impact on the disease (pharmacodynamics), and whether it causes any immune response (immunogenicity). Participants are randomly assigned to receive either MK-6194 or a matching placebo.

What are the potential side effects?

While specific side effects for MK-6194 aren't listed here, common risks may include reactions related to immune system activation such as flu-like symptoms, injection site reactions, potential worsening of UC symptoms initially due to immune changes caused by treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have active or untreated tuberculosis.

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My ulcerative colitis is active.

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I've tried at least 1 treatment without success or couldn't tolerate it, but no more than 2.

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I am using or willing to use effective birth control methods.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously received IL-2 or similar therapy.

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I do not have any serious illnesses besides ulcerative colitis.

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I have had an opportunistic infection in the past.

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My cancer is only in the rectum.

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I have been diagnosed with toxic megacolon.

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I am on long-term medication for an infection.

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I am currently on treatment that reduces my white blood cells.

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I have severe inflammation of my colon.

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I have received an organ or tissue transplant from another person.

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I have a history of major heart, lung, kidney, liver, or brain problems.

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I might have a narrowing in my colon.

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I have been diagnosed with Crohn's disease or indeterminate colitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 85 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 85 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 85 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Discontinuing Study Treatment Due to an AE

Percentage of Participants Experiencing Adverse Events (AEs)

Secondary study objectives

Apparent Clearance (CL/F) of MK-6194

Apparent Half-life (t1/2) of MK-6194

Apparent Volume of Distribution (Vd/F) of MK-6194

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MK-6194Experimental Treatment1 Intervention

Participants will be enrolled in sequential cohorts treated with successively higher doses of MK-6194 via subcutaneous injection.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive MK-6194-matching placebo via subcutaneous injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-6194

2022

Completed Phase 1

~150

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Ulcerative Colitis (UC) include immunomodulatory agents, 5-aminosalicylic acid (5-ASA) medications, glucocorticoids, and tumor necrosis factor (TNF) inhibitors. Immunomodulatory agents like azathioprine and 6-mercaptopurine work by suppressing the immune system to reduce inflammation, which is crucial for preventing flare-ups and maintaining remission. 5-ASA medications, such as mesalamine, act locally in the colon to reduce inflammation and are effective in maintaining remission. Glucocorticoids like prednisone are used for their potent anti-inflammatory effects but are not suitable for long-term use due to side effects. TNF inhibitors, such as infliximab and adalimumab, target and neutralize TNF-alpha, a cytokine involved in systemic inflammation, providing rapid relief and long-term control of symptoms. These treatments are essential for managing UC as they help control inflammation, prevent complications, and improve the quality of life for patients.