Back to resultsA Comparison of 188-0551 Solution Versus Vehicle Solution in Subjects With Plaque Psoriasis (Study 203)
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
188-0551 Solution
Vehicle Solution
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Subject is male or non-pregnant female and is at least 18 years of age.
- Subject has provided written informed consent.
- Subject is willing and able to apply the test article(s) as directed.
- Subject has a clinical diagnosis of stable plaque psoriasis.
- Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
- Females must be post-menopausal, surgically sterile or use an effective method of birth control, with a negative urine pregnancy test (UPT) at the Baseline Visit.
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 a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis.
- Subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to the Baseline Visit.
- Subject has used any systemic tofacitinib, apremilast, methotrexate, retinoids, systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids], cyclosporine or analogous products within 90 days prior to the Baseline Visit.
- Subject has used any systemic anti-inflammatory biologic therapy.
- Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the Baseline Visit or is intending to have such exposure during the study which in the opinion of the investigator is thought to modify the subject's disease.
- Subject has used topical body (excluding the scalp) psoriasis therapy (including coal tar, anthralin, steroids, retinoids and vitamin D analogs) within 14 days prior to the Baseline Visit.
- Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at the Baseline Visit.
- Subject is currently using lithium or Plaquenil (hydroxychloroquine).
- Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized, in the opinion of the investigator.
- Subject has a history of sensitivity to corticosteroids or any of the ingredients in the test articles.
- 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 the Baseline Visit.
- Subject has been previously enrolled in this study and treated with a test article.
Sites / Locations
- Site 01
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
188-0551 Solution
Vehicle Solution
Arm Description
188-0551 Solution applied topically twice daily
Vehicle Solution applied topically twice daily
Outcomes
Primary Outcome Measures
Proportion of subjects rated a treatment success based on the Investigator's Global Assessment (IGA)
The primary efficacy endpoint will be the proportion of subjects with IGA treatment success at EOS where EOS is the subject's last completed post-Baseline visit (Day 15 or 29).
Secondary Outcome Measures
Proportion of subjects rated a treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)
Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee.
Change from Baseline in pruritus score
At the Baseline Visit, prior to the first application of the test article, the subject's overall experience of pruritus within the previous two (2) weeks will be assessed using a questionnaire that assesses the degree, duration, direction, disability, and distribution of the subject's pruritus. At Days 15 and 29, the overall experience of pruritus, in the previous two weeks, will be scored using the same questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03065556
Brief Title
A Comparison of 188-0551 Solution Versus Vehicle Solution in Subjects With Plaque Psoriasis (Study 203)
Official Title
A Double-Blind, Randomized, Multicenter, Vehicle-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 188-0551 in Subjects With Plaque Psoriasis Receiving Up To Four Weeks of Twice-Daily Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 26, 2017 (Actual)
Primary Completion Date
July 6, 2017 (Actual)
Study Completion Date
December 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This Phase 2 study (Study 203) has been designed to determine and compare the efficacy and safety of 188-0551 Solution and Vehicle Solution applied twice daily for up to four weeks in subjects with plaque psoriasis. Subjects will be instructed to apply the test article (188-0551 Solution or Vehicle Solution) to all psoriasis plaques within the designated Treatment Area twice daily for four weeks (Study Day 29), unless the investigator verifies the subject's psoriasis has cleared at Day 15, then test article application will be for 2 weeks (Study Day 15).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
188-0551 Solution
Arm Type
Experimental
Arm Description
188-0551 Solution applied topically twice daily
Arm Title
Vehicle Solution
Arm Type
Placebo Comparator
Arm Description
Vehicle Solution applied topically twice daily
Intervention Type
Drug
Intervention Name(s)
188-0551 Solution
Intervention Description
Topical solution containing active drug
Intervention Type
Drug
Intervention Name(s)
Vehicle Solution
Intervention Description
Topical solution containing no active drug
Primary Outcome Measure Information:
Title
Proportion of subjects rated a treatment success based on the Investigator's Global Assessment (IGA)
Description
The primary efficacy endpoint will be the proportion of subjects with IGA treatment success at EOS where EOS is the subject's last completed post-Baseline visit (Day 15 or 29).
Time Frame
End of Study (Day 15 or 29)
Secondary Outcome Measure Information:
Title
Proportion of subjects rated a treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)
Description
Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee.
Time Frame
End of Study (Day 15 or 29)
Title
Change from Baseline in pruritus score
Description
At the Baseline Visit, prior to the first application of the test article, the subject's overall experience of pruritus within the previous two (2) weeks will be assessed using a questionnaire that assesses the degree, duration, direction, disability, and distribution of the subject's pruritus. At Days 15 and 29, the overall experience of pruritus, in the previous two weeks, will be scored using the same questionnaire.
Time Frame
End of Study (Day 15 or 29)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is male or non-pregnant female and is at least 18 years of age.
Subject has provided written informed consent.
Subject is willing and able to apply the test article(s) as directed.
Subject has a clinical diagnosis of stable plaque psoriasis.
Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
Females must be post-menopausal, surgically sterile or use an effective method of birth control, with a negative urine pregnancy test (UPT) at the Baseline Visit.
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 a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis.
Subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to the Baseline Visit.
Subject has used any systemic tofacitinib, apremilast, methotrexate, retinoids, systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids], cyclosporine or analogous products within 90 days prior to the Baseline Visit.
Subject has used any systemic anti-inflammatory biologic therapy.
Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the Baseline Visit or is intending to have such exposure during the study which in the opinion of the investigator is thought to modify the subject's disease.
Subject has used topical body (excluding the scalp) psoriasis therapy (including coal tar, anthralin, steroids, retinoids and vitamin D analogs) within 14 days prior to the Baseline Visit.
Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at the Baseline Visit.
Subject is currently using lithium or Plaquenil (hydroxychloroquine).
Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized, in the opinion of the investigator.
Subject has a history of sensitivity to corticosteroids or any of the ingredients in the test articles.
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 the Baseline Visit.
Subject has been previously enrolled in this study and treated with a test article.
Facility Information:
Facility Name
Site 01
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparison of 188-0551 Solution Versus Vehicle Solution in Subjects With Plaque Psoriasis (Study 203)
We'll reach out to this number within 24 hrs