Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307)

Study Overview
=================
Brief Summary
-----------------
This Phase 3 study (Study 307) has been designed to determine and compare the efficacy and safety of 188-0551 Spray and Vehicle Spray applied twice daily for up to four weeks in subjects with plaque psoriasis. Subjects will be instructed to apply the test article (188-0551 Spray or Vehicle Spray) 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).

Official Title
-----------------
A Double-Blind, Randomized, Multicenter, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Efficacy and Safety of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis Receiving Up to Four Weeks of Twice-Daily Treatment (Study 307)

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: 188-0551 Spray
* Drug: Vehicle Spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is male or non-pregnant female and is at least 18 years of age at time of informed consent. Subject has provided written informed consent. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 10% body surface area (BSA) (excluding the face, scalp, groin, axillae, and other intertriginous areas). Subject has moderate to severe plaque psoriasis. Subject is willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have 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 palmar/plantar psoriasis. 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 been previously enrolled in this study and treated with a test article. Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: 188-0551 Spray<br>188-0551 Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks | Drug: 188-0551 Spray<br>* Topical Spray containing active drug<br>|
| Placebo Comparator: Vehicle Spray<br>Vehicle Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks | Drug: Vehicle Spray<br>* Topical Spray containing no active drug<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA) Success | The primary efficacy endpoint will be the percentage of subjects with IGA treatment success at End of Study (EOS) where EOS is the subject's last completed post-Baseline visit (Day 29). | Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage 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. | Day 29 | 
| Change from Baseline in pruritus score | The proportion of subjects with ≥4 point reduction from Baseline in the Itch Numeric Rating Scale (I-NRS) at Day 29. The I-NRS is based on a 11-point scale where 0 represents no itching and 10 represents worst itch imaginable. | Day 29 | 
| IGA treatment success at Day 15 | The proportion of subjects with IGA treatment success at Day 15. | Day 15 |