A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis

Study Overview
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Brief Summary
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Corticosteroids are one of the mainstays of treatment for subjects with corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to determine and compare the efficacy and safety of a formulation of 122-0551 versus the corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for 14 consecutive days.

Official Title
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A Double-Blind, Randomized, Single Center, Vehicle-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment

Conditions
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Psoriasis, Plaque Psoriasis

Intervention / Treatment
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* Drug: 122-0551
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a clinical diagnosis of stable plaque psoriasis Subject has an ODS score for the Treatment Area of 3 or 4 at study start Exclusion Criteria: Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis. Subject has used any phototherapy, photo-chemotherapy or systemic corticosteroid therapy within 30 days prior to study start Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to study start Subject has used any systemic biologic therapy for the treatment of psoriasis within 5 half-lives of the biologic prior to study start Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start Subject has used topical body (excluding the scalp) psoriasis therapy including coal tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to study start Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at study start Subject is currently using lithium or Plaquenil (hydroxychloroquine) Subject is currently using a beta-blocking medication (e.g., propranolol) or ACE (e.g., lisinopril) inhibitor at a dose that has not been stabilized Subject is pregnant, lactating, or is planning to become pregnant during the study Subject is currently enrolled in an investigational drug or device study Subject has used an investigational drug or investigational device treatment within 30 days prior to study start Subject has been previously enrolled in this study and treated with a test article

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 122-0551<br> | Drug: 122-0551<br>* Applied twice daily for two weeks<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* Applied twice daily for two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overall Disease Severity (ODS) Score | The percentage of subjects with ODS treatment success at EOS where EOS is the subject's last completed visit. Treatment success is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe. | baseline and Day 15 (End of Study - EOS) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ODS Treatment Success at Day 8 and Day 15 | The percentage of subjects with ODS treatment success at Day 8 and Day 15. Treatment success is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe. | baseline, Day 8, and Day 15 | 
| ODS Improved at Day 8 and Day 15 | The percentage of subjects rated improved with respect to ODS at Days 8 and 15. Improved is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe. | baseline, Day 8, and Day 15 | 
| Treatment Success for Clinical Signs and Symptoms of Psoriasis | The percentage of subjects rated treatment success for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. Treatment success is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe. | baseline, Day 8 and Day 15 | 
| Improved for Clinical Signs and Symptoms of Psoriasis | The percentage of subjects rated improved for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. Improved is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe. | baseline, Day 8 and Day 15 | 
| Change in % Body Surface Area (BSA) With Psoriasis | Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15. | baseline, Day 8 and Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, plaque psoriasis, 122-0551, steroid