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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
217
Topical Spray containing active drug
Topical Spray containing no active drug
Site 04
Los Angeles, California, United States
Site 14
Ocala, Florida, United States
Site 01
Macon, Georgia, United States
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).
Time frame: Day 29
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.
Time frame: 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."
Time frame: Day 29
IGA "treatment success" at Day 15
The proportion of subjects with IGA "treatment success" at Day 15.
Time frame: Day 15
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Site 11
Rolling Meadows, Illinois, United States
Site 13
Rockville, Maryland, United States
Site 10
Clinton Township, Michigan, United States
Site 12
Fridley, Minnesota, United States
Site 07
Rochester, New York, United States
Site 06
High Point, North Carolina, United States
Site 05
Norman, Oklahoma, United States
...and 4 more locations