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Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307)

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)

NCT03731052•Therapeutics, Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is male or non-pregnant female and is at least 18 years of age at time of informed consent.
•2. Subject has provided written informed consent.
•3. 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).
•4. Subject has moderate to severe plaque psoriasis.
•5. 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

•1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
•2. Subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
•3. Subject has palmar/plantar psoriasis.
•4. Subject is pregnant, lactating, or is planning to become pregnant during the study.
•5. Subject is currently enrolled in an investigational drug or device study.
•6. Subject has been previously enrolled in this study and treated with a test article.

Locations (14)

Site 04

Los Angeles, California, United States

Site 14

Ocala, Florida, United States

Site 01

Macon, Georgia, United States

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

Key Dates

Start Date

October 16, 2018

Primary Completion Date

December 20, 2019

Completion Date

December 20, 2019

Last Updated

February 25, 2020

Enrollment

217

ACTUAL participants

Conditions

Plaque Psoriasis

Interventions

188-0551 Spray

DRUG

Vehicle Spray

DRUG

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

View study

RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Plaque Psoriasis

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RECRUITINGPHASE2

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

NCT07449702

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307)

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis