- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03731052
Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307)
February 18, 2020 updated by: Therapeutics, Inc.
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)
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
217
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
-
Los Angeles, California, United States, 90045
- Site 04
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Florida
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Ocala, Florida, United States, 34470
- Site 14
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Georgia
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Macon, Georgia, United States, 31217
- Site 01
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Illinois
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Rolling Meadows, Illinois, United States, 60008
- Site 11
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Maryland
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Rockville, Maryland, United States, 20850
- Site 13
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Michigan
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Clinton Township, Michigan, United States, 48038
- Site 10
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Minnesota
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Fridley, Minnesota, United States, 55432
- Site 12
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New York
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Rochester, New York, United States, 14623
- Site 07
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North Carolina
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High Point, North Carolina, United States, 27262
- Site 06
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Oklahoma
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Norman, Oklahoma, United States, 73071
- Site 05
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Site 03
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Texas
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Austin, Texas, United States, 78759
- Site 15
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San Antonio, Texas, United States, 78229
- Site 08
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Virginia
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Norfolk, Virginia, United States, 23502
- Site 02
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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
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Topical Spray containing no active drug
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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
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).
|
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)
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.
|
Day 29
|
Change from Baseline in pruritus score
Time Frame: Day 29
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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."
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Day 29
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IGA "treatment success" at Day 15
Time Frame: Day 15
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The proportion of subjects with IGA "treatment success" at Day 15.
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Day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tony Andrasfay, Therapeutics, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 16, 2018
Primary Completion (Actual)
December 20, 2019
Study Completion (Actual)
December 20, 2019
Study Registration Dates
First Submitted
November 2, 2018
First Submitted That Met QC Criteria
November 2, 2018
First Posted (Actual)
November 6, 2018
Study Record Updates
Last Update Posted (Actual)
February 25, 2020
Last Update Submitted That Met QC Criteria
February 18, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 188-0551-307
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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