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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 85 days

Awards & highlights

Study Summary

This trial is testing a new drug, MK-6194, for safety, side effects, how it works in the body, and if it causes an immune reaction in people with active ulcerative colitis.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Discontinuing Study Treatment Due to an AE

Percentage of Participants Experiencing Adverse Events (AEs)

Secondary outcome measures

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,765 Total Patients Enrolled

5 Trials studying Ulcerative Colitis

2,786 Patients Enrolled for Ulcerative Colitis

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,514 Total Patients Enrolled

15 Trials studying Ulcerative Colitis

4,720 Patients Enrolled for Ulcerative Colitis

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,423 Total Patients Enrolled

8 Trials studying Ulcerative Colitis

4,819 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals does this experiment aspire to accomplish?

"This clinical trial, running for up to 85 days, is principally evaluating the number of participants discontinuing treatment due to adverse events. Secondary measures include the Area Under Curve from time zero to infinity (AUC0-inf) and Apparent Half Life (t1/2) of MK-6194 plasma concentration as well as Titer of anti-drug antibody against MK-6194."

Answered by AI

How many locations are participating in the evaluation of this procedure?

"Patients interested in participating can do so at Southern Star Research Institute ( Site # 0101) in San Antonio, Texas, Pinnacle Clinical Research ( Site 0103) in Raleigh, North carolina and Carolina's GI Research, LLC ( Site 0105) Rialto, California among 6 other sites."

Answered by AI

Does the trial's protocol allow for individuals aged under 20 to participate?

"This medical study is open to adults over 18 years of age, up until the maximum enrolment cut-off point of 80."

Answered by AI

What type of participant is eligible for this research initiative?

"Presently, this experiment is seeking 30 people with colitis aged between 18 and 80. Individuals that are accepted must meet the following criteria: a diagnosis of UC at least three months beforehand; mildly to severely active UC; inadequate response or intolerance to one prior conventional therapy and no more than two advanced therapies; those over 50 years old need documentation for colonoscopy in the last 3 years excluding adenomatous polyps (if excised then eligible); extensive colitis history of 8 years or left side colon involvement 10+ year needs full colonoscopy 1year pre study drug administration or screening visit respectively; lack of latent/active"

Answered by AI

What is the sample size for this medical experiment?

"This trial requires 30 volunteers who are eligible for inclusion. Participants can join from Southern Star Research Institute (Site # 0101) in San Antonio, TX or Pinnacle Clinical Research ( Site 0103) in Raleigh, NC."

Answered by AI

Has the regulatory body approved MK-6194 for human use?

"Due to the limited clinical data regarding MK-6194's safety and efficacy, our team gave it a score of 1 on a scale from 1 to 3."

Answered by AI

Is this trial still recruiting participants?

"The data available on clinicaltrials.gov indicates that this research project is still actively seeking applicants; it was originally posted in October 2021 and the information was last edited in November of 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002)

2021. "A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04924114.

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