Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Prior treatment

• Major surgery within 8 weeks prior to baseline or has a major surgery planned during the study
• Known history of clinically significant drug or alcohol abuse in the last year prior to baseline
• Use of any prohibited medication or procedure within the indicated period before the baseline visit until the completion of the study completion or study discontinuation
• Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)

Other illness

• Any sign of infection of any of the psoriatic lesions
• Current or chronic history of liver disease
• Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
• History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion may interfere with the subject's participation in the study, interpretation of results, safety of the subject or ability to understand and give informed consent
• History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation

Lab values

• Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN)
• Screening total bilirubin \> 1.5x ULN

Other

• Psoriasis other than plaque variant
• Immunocompromised at screening
• Pregnant or lactating females.

• Male and female subjects ages 2 to 17 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 3 months prior to the baseline visit
• Subject with plaque psoriasis covering ≥ 3% of the BSA at screening and baseline
• A PGA score of ≥ 2 at screening and baseline
• Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
• Must not be pregnant
• Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent