A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis
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 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).
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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|Eligible Ages||18 Years and Over|
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. 6. 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. Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Therapeutics, Inc.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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