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MK-0873 Patch

Phase 1

Plaque Psoriasis | Small molecule | Immunology |Merck & Company, Inc.|Last Updated: Feb 8, 2019

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01140061Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)PHASE1 COMPLETED 42May 1, 2010Mar 1, 2011Feb 8, 2019 -
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Study Endpoints
Primary Endpoints
Number of Participants With an Adverse Event of Erythema in Part I of the Study
Up to Day 22 in Part 1

Following topical administration of MK-0873 or matching placebo patches once daily for 21 days, the number of participants with an adverse event of erythema was recorded. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days
Day 11

Participant blood samples were collected on Day 11 to determine the Cmax of MK-0873 following topical administration in healthy participants and participants with psoriasis

Number of Participants With an Adverse Event
Up to 14 days after last dose of study drug (up to Day 42)

An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Number of Participants Who Discontinued Study Medication Due to an Adverse Event
Up to Day 28

An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Panel A - MK-0873 5.1 mgEXPERIMENTALIn Part I, healthy participants received skin patches containing nothing (plain patch), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg of MK- 0873) once daily for 21 days.
Panel A - PlaceboPLACEBO_COMPARATORIn Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days.
Panel B - MK-0873 25 mgEXPERIMENTALIn Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK- 0873) twice daily for 10 days.
Panel B - PlaceboPLACEBO_COMPARATORIn Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
Panel C - MK-0873 100 mgEXPERIMENTALIn Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
Panel C - PlaceboPLACEBO_COMPARATORIn Part II, healthy participants received skin application of placebo cream once daily for 10 days.
Panel D - MK-0873 200 mgEXPERIMENTALIn Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
Panel D - PlaceboPLACEBO_COMPARATORIn Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
Panel E and Extension - MK-0873 200 mgEXPERIMENTALIn Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
Panel E and Extension - PlaceboPLACEBO_COMPARATORIn Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
Interventions
NameTypeDescription
MK-0873 PatchDRUGMK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873
MK-0873 CreamDRUGMK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873
Placebo PatchDRUGPlacebo patches matching MK-0873 0.05%, 0.5%, or 2% patches
Placebo CreamDRUGPlacebo cream matching MK-0873 0.05%, 0.5%, or 2%
Plain patchDRUGPlain patch containing no MK-0873 or placebo
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: Part I, II and III: * Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control; * In good general health; * Nonsmoker; Part III only: * Has diagnosis of plaque-type psoriasis, and has lesions cover...

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