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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Plaque Psoriasis
• Intervention / Treatment: Drug: 122-0551; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Vehicle	Drug: Vehicle; Applied twice daily for two weeks
EXPERIMENTAL: 122-0551	Drug: 122-0551; Applied twice daily for two weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: October 2, 2012
• First Posted (ESTIMATE): October 4, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2018
• Last Update Submitted That Met QC Criteria: September 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: psoriasis; steroid; plaque psoriasis; 122-0551
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 122-0551-203