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MK-0873 2%

Phase 1

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-BlindCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

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% used for?

MK-0873 2% is an investigational small molecule being developed for the treatment of plaque psoriasis, a form of psoriasis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its efficacy and pharmacokinetics in patients with this condition.

Who makes MK-0873 2%?

MK-0873 2% is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in treating 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 other regulatory agency. The Phase 1 trial has been completed, and the drug remains under investigation for the treatment of plaque psoriasis.

What clinical trials is MK-0873 2% in?

MK-0873 2% has been studied in one completed Phase 1 clinical trial, identified as NCT01235728. This trial, titled "A Study to Evaluate and Compare the Efficacy and Pharmacokinetics of MK-0873 for the Treatment of Plaque Psoriasis (MK-0873-022)," enrolled 24 participants in the United States. The study was randomized, double-blind, and controlled.

Is MK-0873 2% the same as MK-0873?

MK-0873 2% is a specific formulation or concentration of the investigational drug MK-0873. The 2% designation refers to the concentration of the active ingredient in the formulation being studied. The clinical trial NCT01235728 evaluates this 2% formulation for the treatment of plaque psoriasis.