Status:
COMPLETED
A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis
Lead Sponsor:
Therapeutics, Inc.
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This Phase 3 study (Study 305) 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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2019
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT03759197
Start Date
November 26 2018
End Date
August 27 2019
Last Update
February 25 2020
Active Locations (12)
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1
Site 06
Fort Smith, Arkansas, United States, 72916
2
Site 09
Fountain Valley, California, United States, 92708
3
Site 07
Fremont, California, United States, 94538
4
Site 02
Aventura, Florida, United States, 33180