Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307)
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|ClinicalTrials.gov Identifier: NCT03731052|
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: 188-0551 Spray Drug: Vehicle Spray||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Actual Study Start Date :||October 16, 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Drug: 188-0551 Spray
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
Topical Spray containing active drug
Placebo Comparator: Vehicle Spray
Vehicle Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks
Drug: Vehicle Spray
Topical Spray containing no active drug
- Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA) Success [ Time Frame: Day 29 ]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).
- Percentage of subjects rated a treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) [ Time Frame: Day 29 ]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 [ Time Frame: Day 29 ]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."
- IGA "treatment success" at Day 15 [ Time Frame: Day 15 ]The proportion of subjects with IGA "treatment success" at Day 15.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731052
|Contact: TI Clinical Operations||1-858-571-1800 ext 147||ClinicalResearch@therapeuticsinc.com|
|United States, Minnesota|
|Fridley, Minnesota, United States, 55432|
|Contact 858-571-1800 ext 147|
|United States, New York|
|Rochester, New York, United States, 14623|
|Contact 858-571-1800 ext 147|
|Study Director:||Tony Andrasfay||Therapeutics, Inc.|