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MK-0873 2%

Phase 1

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

MK-0873 2% target and mechanism

Molecular targetPDE4A, PDE4D, PDE4B, PDE4C
Target classInhibitor
ModalitySmall molecule

Also known as MK-0873 2% Cream

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

MK-0873 2% clinical trials

MK-0873 2% · 1 trial · 2 indications

Phase 1 1
NCT01235728A Study to Evaluate and Compare the Efficacy and Pharmacokinetics of MK-0873 for the Treatment of Plaque Psoriasis (MK-0873-022)Psoriasis
COMPLETED24 Analytics
PHASE1COMPLETED
A Study to Evaluate and Compare the Efficacy and Pharmacokinetics of MK-0873 for the Treatment of Plaque Psoriasis (MK-0873-022)
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Least Squares Mean Percent Change From Baseline (Predose Day 1) of Target Lesion Severity (TLS) Score for Lesions Treated With MK-0873 and Lesions Treated With MK-0873 Vehicle
Baseline and Day 29

Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.

Secondary Endpoints

Least Squares Mean Percent Change From Baseline (Predose Day 1) of TLS Score for Lesions Treated With MK-0873 and Lesions Treated With Calcitriol
Baseline and Day 29
Mean Maximum Plasma Concentrations at Trough of Day 8, 15, 22, and 29 Following Topical Administration of MK-0873 to Psoriatic Patients
Day 8, 15, 22, 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Sequence 1EXPERIMENTALParticipants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
Treatment Sequence 2EXPERIMENTALParticipants were randomized to received MK-0873 on lower lesion A and vehicle on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
Treatment Sequence 3EXPERIMENTALParticipants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
Treatment Sequence 4EXPERIMENTALParticipants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and calcitriol on upper lesion C and MK-0873 on upper lesion D.
Treatment Sequence 5EXPERIMENTALParticipants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
Treatment Sequence 6EXPERIMENTALParticipants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
Treatment Sequence 7EXPERIMENTALParticipants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
Treatment Sequence 8EXPERIMENTALParticipants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and calcitriol on upper lesion C and MK-0873 on upper lesion D.

Interventions

NameTypeDescription
MK-0873 2% CreamDRUGApproximately 3 to 5 mg of MK-0873 2% cream per cm\^2 of body area in 2 divided applications per day for 28 days. The maximum area for one treatment will be approximately 5% of body surface area.
MK-0873 vehicle (placebo) CreamDRUGApproximately 3 to 5 mg matching placebo to MK-0873 2% cream per cm\^2 of body area in 2 divided applications per day for 28 days. The maximum area for one treatment will be approximately 5% of body surface area.
Calcitriol CreamDRUGApproximately 3 to 5 mg of Calcitriol 0.0003% (3 µg/g) per cm\^2 of body area once daily for 28 days. The maximum area for one treatment will be approximately 5% of body surface area
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria * Is a male or female 18 to 65 years of age * Female subjects of reproductive potential must have a negative serum pregnancy test at screening and agree to use and/or have their partner use two (2) acceptable methods of birth control * Has a Body Mass Index (BMI) ≤36 kg/m\^2 (up ...

Countries:United States
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Frequently asked questions about MK-0873 2%

What is MK-0873 2%?

MK-0873 2% is an investigational small molecule developed by Merck & Company, Inc. (MRK) for the treatment of psoriasis. It is a topical cream formulation being studied in clinical development. MK-0873 2% is also known as MK-0873 2% Cream.

What is MK-0873 2% used for?

MK-0873 2% is being studied for the treatment of plaque psoriasis, a chronic inflammatory skin condition. It is a topical cream applied to the skin. The drug is investigational and has not been approved for any indication.

What does MK-0873 2% target?

MK-0873 2% targets phosphodiesterase 4 (PDE4), specifically the PDE4A, PDE4B, PDE4C, and PDE4D subtypes. It acts as a PDE4 inhibitor. By inhibiting PDE4, the drug is designed to modulate inflammatory signaling pathways involved in psoriasis.

Who makes MK-0873 2%?

MK-0873 2% is developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical program evaluating the topical cream for plaque psoriasis.

What phase is MK-0873 2% in?

MK-0873 2% is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any regulatory authority. The Phase 1 trial has been completed.

What clinical trials is MK-0873 2% in?

MK-0873 2% was evaluated in one completed Phase 1 trial, NCT01235728, titled A Study to Evaluate and Compare the Efficacy and Pharmacokinetics of MK-0873 for the Treatment of Plaque Psoriasis. The trial enrolled 24 participants in the United States and was randomized, double-blind, and controlled.