MK-6194 for Ulcerative Colitis

Charite Research Organisation GmbH ( Site 0201), Berlin, Germany
Ulcerative ColitisMK-6194 - Drug
18 - 80
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Ulcerative Colitis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

2 Primary · 13 Secondary · Reporting Duration: Days 1, 29, 57, and 85

Day 85
Apparent Clearance (CL/F) of MK-6194
Apparent Half-life (t1/2) of MK-6194
Apparent Volume of Distribution (Vd/F) of MK-6194
Area Under the Concentration Time-curve From Time 0 to the Last Quantifiable Concentration (AUC0-t)
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of MK-6194
Maximum Concentration (Cmax) of MK-6194
Minimum Concentration (Cmin) of MK-6194
Time to Cmax (Tmax) of MK-6194
Titer of anti-drug antibody (ADA) to MK-6194
Day 85
Change in Number of Conventional T Cells (Tcons) in Whole Blood
Change in Number of Natural Killer (NK) Cells in Whole Blood
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
Day 1
Titer of anti-drug antibody (ADA) of MK-6194
Day 85
Percentage of Participants Discontinuing Study Treatment Due to an AE
Percentage of Participants Experiencing Adverse Events (AEs)

Trial Safety

Phase-Based Safety

1 of 3

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Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: MK-6194 · Has Placebo Group · Phase 1

Experimental Group · 1 Intervention: MK-6194 · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: MK-6194-matching placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: days 1, 29, 57, and 85

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,735 Previous Clinical Trials
4,973,444 Total Patients Enrolled
14 Trials studying Ulcerative Colitis
3,700 Patients Enrolled for Ulcerative Colitis
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,578,365 Total Patients Enrolled
5 Trials studying Ulcerative Colitis
2,786 Patients Enrolled for Ulcerative Colitis
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,669 Previous Clinical Trials
7,959,337 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
3,799 Patients Enrolled for Ulcerative Colitis

Eligibility Criteria

Age 18 - 80 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have tried at least one standard treatment but it did not work well, or you could not tolerate it. You have also tried no more than two advanced treatments.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Is this trial still recruiting participants?

"The data available on 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.