Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis

Study Overview
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Brief Summary
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Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the efficacy and safety of CTA018 in the treatment of psoriasis. Patients with chronic plaque psoriasis will receive one of three doses of CTA018 cream or vehicle (no study drug) daily for 12 weeks.

Official Title
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A Randomized, Double-blind, Parallel-group, 4-arm, 12-week Study to Evaluate the Safety and Efficacy of Topically Applied CTA018 vs Vehicle for the Treatment of Adult Subjects With Chronic Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: CTA018 cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of chronic plaque psoriasis for 6 months to a max 15% body surface area excluding face, scalp, groin, axillae, palms, soles of feet at least two evaluable plaques with CPSS >/= 6 baseline PSGA >/= 2 women of childbearing potential msut agree to use an effective form of contraception Exclusion Criteria: cannot have guttate, pustular, erythrodermic or other non-plaque forms of psoriasis cannot have concomitant serious illness/condition that may interfere with participation in the study cannot have used topical therapy within 2 weeks prior to baseline visit cannot have used photo-therapy or systemic psoriasis therapy within 4 weeks prior to baseline visit cannot have had prolonged exposure to natural or artificial UV radiation within 4 weeks of baseline visit or intend to have exposure during the study cannot have used systemic immunomodulatory therapy within 12 weeks prior to baseline visit cannot have a history of hypercalcemia or kidney stones cannot be unable or unwilling to discontinue calcium and/or vitamin D supplementation during the study cannot be pregnant or a nursing mother cannot be participating in or have participated in an interventional study within 30 days of study start

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CTA018 cream|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy outcomes include time to success (PSGA), change in overall PSGA score, and Area Adjusted Psoriasis Area and Severity Index (AAPASI)changes from baseline. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis