NCT01882647CompletedPhase 3
A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Therapeutics, Inc.
- Enrollment
- 222
- Locations
- 10
- Primary Endpoint
- The Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
Study Overview
Brief Summary
This Phase 3 study has been designed to determine and compare the efficacy and safety of 000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque psoriasis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% affected body surface area.
- •Subject has an Investigator's Global Assessment (IGA) score of at least three (moderate) at study start.
- •If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study
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 (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to study start.
- •Subject has used any systemic methotrexate, retinoids, systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids], cyclosporine or analogous products within 90 days prior to study start.
- •Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five 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 or is intending to have such exposure during the study.
- •Subject has used topical body (excluding the scalp) psoriasis therapy (including coal tar, anthralin, steroids, retinoids, vitamin D analogs) 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., propanolol) or angiotensin converting enzyme (ACE) 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.
Arms & Interventions
Active Arm
Experimental
Topical lotion, applied twice daily
Intervention: 000-0551 Lotion (Drug)
Vehicle Arm
Placebo Comparator
Topical lotion, applied twice daily
Intervention: Vehicle Lotion (Drug)
Outcomes
Primary Outcomes
The Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
Time Frame: Day 15
The IGA score is a static evaluation of the overall or "average" degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Secondary Outcomes
- The Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)(Day 15)
Investigators
Study Sites (10)
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