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MK-0873 Patch

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

MK-0873 Patch · 1 trial · 1 indication

Phase 1 1
NCT01140061Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)Plaque Psoriasis
COMPLETED42 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)
Plaque PsoriasisUnlock trial analytics

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 to 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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Frequently asked questions about MK-0873 Patch

What is MK-0873 used for?

MK-0873 is an investigational small molecule being studied for rheumatoid arthritis and plaque psoriasis. It is being developed by Merck & Company, Inc. (MRK). The drug has completed a Phase 2 trial in rheumatoid arthritis and a Phase 1 trial in plaque psoriasis, but it is not approved and remains in clinical development.

Who makes MK-0873?

MK-0873 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company has sponsored clinical trials of the drug in rheumatoid arthritis and plaque psoriasis.

What phase is MK-0873 in?

MK-0873 is in Phase 2 clinical development. A Phase 2 trial in rheumatoid arthritis has been completed, and a Phase 1 trial in plaque psoriasis has also been completed. The drug is investigational and not approved.

What clinical trials is MK-0873 in?

MK-0873 has been studied in two completed trials. NCT00132769 was a Phase 2, randomized, double-blind, placebo-controlled study in 106 rheumatoid arthritis patients. NCT01140061 was a Phase 1 study in 42 healthy participants and psoriasis participants.

Is MK-0873 the same as another drug?

MK-0873 is the code name used by Merck for this investigational compound. No alternative brand or generic names have been disclosed in the clinical trial records.