Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis

Korábbi kezelés

• Subjects who were not receiving study drug at the time of the last visit in the pivotal study (DMVT-505-3101, DMVT-505-3102, or DMVT-505-2104)
• Used a prohibited concomitant product or procedure to treat AD during the pivotal study.
• Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit
• Subjects who would not be considered suitable for topical therapy
• Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
• Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)

Más betegség

• Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
• 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, 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

Laborértékek

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

Egyéb

• For Rollover Subjects Only:
• Had an SAE that was related to treatment or experienced an AE that led to permanent discontinuation of treatment in the pivotal study.
• Pregnant females
  • For Direct-Enrolling Subjects:
• Immunocompromised at screening
• Pregnant or lactating females

• For Roll-over Subjects Only:
• Met the criteria as a Study Completer in one of three studies (DMVT-505-3101 study, DMVT-505-3102 study, or DMVT-505-2104 study).
• Must not be pregnant at Baseline
  • For Direct-Enrolling Subjects Only:
• Male and female subjects ages 2 years to < 18 years at the time of consent with clinical diagnosis of AD
• Subjects with a vIGA-AD™ score of ≥ 3 and AD covering ≥ 40% of the BSA at Screening and Baseline (pre-randomization), or subjects with a vIGA-AD™ score of 2 at Screening and Baseline (pre-randomization) regardless of BSA. Subjects must have screened for the DMVT-505-3101 or DMVT-505-3102 study and failed to meet BSA and/or vIGA-AD™ eligibility criteria.
• AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
• Must not be pregnant at Screening or Baseline
  • For All Subjects:
• Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
• Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent