A Study to Evaluate and Compare the Effectiveness and Metabolism of MK-0873 for the Treatment of Plaque Psoriasis (MK-0873-022-AM1)
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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 |
- 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.
- 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:
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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:
|
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 May 16, 2013