Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307)
NCT03731052 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 217
Last updated 2020-02-25
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).
Conditions
Interventions
- DRUG
-
188-0551 Spray
Topical Spray containing active drug
- DRUG
-
Vehicle Spray
Topical Spray containing no active drug
Sponsors & Collaborators
-
Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Tony Andrasfay · Therapeutics, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-16
- Primary Completion
- 2019-12-20
- Completion
- 2019-12-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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