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

Primary Purpose

Psoriasis, Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
122-0551
Vehicle
Sponsored by
Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, plaque psoriasis, 122-0551, steroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Therapeutics Clinical Research
  • DermResearch, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

122-0551

Vehicle

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
"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.
"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.
Change in % Body Surface Area (BSA) With Psoriasis
Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.

Full Information

First Posted
September 27, 2012
Last Updated
September 28, 2018
Sponsor
Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01700985
Brief Title
A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Plaque Psoriasis
Keywords
psoriasis, plaque psoriasis, 122-0551, steroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
122-0551
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
122-0551
Intervention Description
Applied twice daily for two weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Applied twice daily for two weeks
Primary Outcome Measure Information:
Title
Change in Overall Disease Severity (ODS) Score
Description
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.
Time Frame
baseline and Day 15 (End of Study - EOS)
Secondary Outcome Measure Information:
Title
ODS "Treatment Success" at Day 8 and Day 15
Description
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.
Time Frame
baseline, Day 8, and Day 15
Title
ODS "Improved" at Day 8 and Day 15
Description
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.
Time Frame
baseline, Day 8, and Day 15
Title
"Treatment Success" for Clinical Signs and Symptoms of Psoriasis
Description
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.
Time Frame
baseline, Day 8 and Day 15
Title
"Improved" for Clinical Signs and Symptoms of Psoriasis
Description
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.
Time Frame
baseline, Day 8 and Day 15
Title
Change in % Body Surface Area (BSA) With Psoriasis
Description
Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.
Time Frame
baseline, Day 8 and Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syd Dromgoole, PhD
Organizational Affiliation
Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States

12. IPD Sharing Statement

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

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