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

Phase 2

Completed

Conditions: Psoriasis
Plaque Psoriasis

Interventions: Drug: Vehicle
Drug: 122-0551

Registration Number: NCT01700985

Lead Sponsor: Therapeutics, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	-
122-0551	122-0551	-

Primary Outcome Measures

Name	Time	Method
Change in Overall Disease Severity (ODS) Score	baseline and Day 15 (End of Study - EOS)	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.

Secondary Outcome Measures

Name	Time	Method
ODS "Improved" at Day 8 and Day 15	baseline, 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.
"Treatment Success" for Clinical Signs and Symptoms of Psoriasis	baseline, Day 8 and Day 15	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.
ODS "Treatment Success" at Day 8 and Day 15	baseline, 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.
"Improved" for Clinical Signs and Symptoms of Psoriasis	baseline, Day 8 and Day 15	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.
Change in % Body Surface Area (BSA) With Psoriasis	baseline, Day 8 and Day 15	Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.