A Study to Evaluate and Compare the Effectiveness and Metabolism of MK-0873 for the Treatment of Plaque Psoriasis (MK-0873-022-AM1)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01235728
First received: November 4, 2010
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

This is a within-participant comparison study to investigate the efficacy of MK-0873 2% cream twice a day (b.i.d.) compared to MK-0873 vehicle (matching placebo) b.i.d. as well as to a positive control comparator calcitriol 0.0003% (3 µg/g) in participants with plaque psoriasis. In order to be enrolled in the study, patients need to have at least two pairs (lesions AB and CD) of approximately similar plaque lesions in severity and size of surface area involved and located in approximately symmetric regions such as the trunk or limbs of the body. Participants will be randomly assigned to apply either MK-0873 or MK-0873 vehicle to plaque A or B and will be randomly assigned to apply MK-0873 or calcitriol plaque C or D. It is assumed that MK-0873 cream formulation administered to participants with psoriasis by the topical route results in a statistically greater percent target lesion severity (TLS) reduction in plaque lesions treated with MK-0873 than in plaque lesions treated with MK-0873 Vehicle on Day 29.


Condition Intervention Phase
Psoriasis
Plaque Psoriasis
Drug: 2% MK-0873 Cream
Drug: MK-0873 vehicle (placebo)
Drug: Calcitriol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Active-Comparator-, and Vehicle-Controlled, Multiple-Dose Study to Evaluate the Efficacy and Pharmacokinetics of MK-0873 in Patients With Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
    Each lesion will be evaluated for 3 components: erythema, induration, and scaling. Each component will be given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The TLS score is calculated as a sum of the 3 components.


Secondary Outcome Measures:
  • Percent change from baseline (predose day 1) of Target Lesion Severity (TLS) score comparing MK-0873 to calcitriol [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
    Each lesion will be evaluated for 3 components: erythema, induration, and scaling. Each component will be given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The TLS score is calculated as a sum of the 3 components.

  • Plasma concentration at 12 hours (C12 hr) of MK-0873 [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-0873 active for lesion A or B
Participant will be randomly assigned to apply 2% MK-0873 to either lesion A or B
Drug: 2% MK-0873 Cream
Approximately 3 to 5 mg of 2% MK-0873 cream per cm^2 of body area in 2 divided applications per day. The maximum area for one treatment will be approximately 5% of body surface area.
Placebo Comparator: MK-0873 vehicle (placebo) for lesion A or B
Participant will be randomly assigned to apply 2% MK-0873 vehicle (placebo) to either lesion A or B
Drug: MK-0873 vehicle (placebo)
Approximately 3 to 5 mg of placebo cream per cm^2 of body area in 2 divided applications per day. The maximum area for one treatment will be approximately 5% of body surface area.
Experimental: MK-0873 active for lesion C or D
Participant will be randomly assigned to apply 2% MK-0873 to either lesion C or D
Drug: 2% MK-0873 Cream
Approximately 3 to 5 mg of 2% MK-0873 cream per cm^2 of body area in 2 divided applications per day. The maximum area for one treatment will be approximately 5% of body surface area.
Active Comparator: Calcitriol 0.0003% (3 µg/g) for lesion C or D
Participant will be randomly assigned to apply Calcitriol 0.0003% (3 µg/g) to either lesion C or D
Drug: Calcitriol
Approximately 3 to 5 mg of Calcitriol 0.0003% (3 µg/g) per cm^2 of body area daily. The maximum area for one treatment will be approximately 5% of body surface area
Other Names:
  • Calcijex
  • Rocaltrol
  • Vectical

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 to 40 kg/m^2 may be enrolled, in consultation with Sponsor)
  • Has diagnosis of plaque-type psoriasis at least 6 month prior to administration of study drug (participants with concurrent psoriatic arthritis may be enrolled)
  • Has plaque-type psoriasis with at least two pairs of symmetrically located plaque lesions that exhibit similar baseline TLS values (TLS in each plaque ≥6 and

    ± 2 points difference between left and right plaque lesions)

  • Has plaque-type psoriasis with lesion severity score ≥4 covering at least 1 to 20% of total body surface area (BSA) at screening and at baseline.
  • Is judged to be in good health based on medical history, physical examination, vital sign measurements, electrocardiogram assessment, and laboratory safety tests

Exclusion Criteria

  • Has nonplaque forms of psoriasis (e.g., Erythrodermic, guttate, or pustular).
  • Has current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers or lithium).
  • Has received phototherapy or any systemic medications/treatments that could affect psoriasis or TLS evaluation (including but not limited to oral or injectable corticosteroids, retinoids, 1, 25-dihydroxy vitamin D3 and analogues, psoralens, sulfsalazine, hydroxyurea, fumaric acid derivatives, or herbal treatments) within 4 weeks of study drug administration.
  • Has used topical medications/treatments that could affect psoriasis or TLS evaluation (e.g., corticosteroids, coal tar, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethyl psoralens) within 2 weeks of study drug administration.
  • Has used any systemic immunosuppressants (e.g., Methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, or tacrolimus) with 4 weeks of study drug administration or biologics (e.g., anti TNF, anti interleukins) with 3 months of study drug administration.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235728

Locations
United States, Florida
Call for Information
Fort Myers, Florida, United States, 33901
Call for Information
Miramar, Florida, United States, 33025
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01235728     History of Changes
Other Study ID Numbers: MK-0873-022
Study First Received: November 4, 2010
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Plaques psoriasis
MK-0873
Calcitriol

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014