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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
Awards & highlights

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 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
~130

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.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,522 Total Patients Enrolled
5 Trials studying Ulcerative Colitis
2,786 Patients Enrolled for Ulcerative Colitis
Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,926 Total Patients Enrolled
15 Trials studying Ulcerative Colitis
4,689 Patients Enrolled for Ulcerative Colitis
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,079,723 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
4,997 Patients Enrolled for Ulcerative Colitis

Media Library

MK-6194 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04924114 — Phase 1
Ulcerative Colitis Research Study Groups: MK-6194, Placebo
Ulcerative Colitis Clinical Trial 2023: MK-6194 Highlights & Side Effects. Trial Name: NCT04924114 — Phase 1
MK-6194 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04924114 — Phase 1
~15 spots leftby Sep 2025
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