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MK-6194

Phase 1

Ulcerative Colitis | Small molecule | Immunology |Merck & Company, Inc.|Last Updated: Aug 29, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment57
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04924114A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002)PHASE1 COMPLETED 57Oct 14, 2021Jul 15, 2024Aug 29, 202517 United States, Georgia +6
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Study Endpoints
Primary Endpoints
Number of Participants Who Experienced an Adverse Event (AE)
Up to approximately 85 days

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Number of Participants Who Interrupted or Discontinued Study Treatment Due to an AE
Up to approximately 72 days

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to thestudy intervention

Secondary Endpoints
Maximum Concentration (Cmax) of MK-6194
Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85.
Time to Cmax (Tmax) of MK-6194
Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85
Minimum Concentration (Cmin) of MK-6194
Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-6194 Low Dose - Interval 1 (Less Frequent)EXPERIMENTALParticipants received low dose of MK-6194 at specified less frequent intervals
MK-6194 Medium Dose- Interval 2 (More Frequent)EXPERIMENTALParticipants received medium dose of MK-6194 at specified more frequent intervals
MK-6194 High Dose- Interval 2 (More Frequent)EXPERIMENTALParticipants received high dose of MK-6194 at specified more frequent intervals
MK-6194 High Dose- Interval 1 (Less Frequent)EXPERIMENTALParticipants received high dose MK-6194 at specified less frequent intervals
PlaceboPLACEBO_COMPARATORParticipants received MK- 6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
Interventions
NameTypeDescription
MK-6194DRUGSubcutaneous injection
MK-6194-matching placeboDRUGSubcutaneous injection
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Diagnosis of UC at least 3 months prior to screening. * Mildly to severely active UC. * Inadequate response, loss of response, or intolerance to at least 1 prior conventional therapy, and no more than 2 prior advanced therapies. * Participants at risk for colorectal cancer mus...

Countries:United StatesGeorgiaGermanyHungaryMoldovaPolandUkraineUnited Kingdom
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