Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema

Exclusion Criteria

• •1. Subjects with any serious medical or psychiatric condition or clinically significant physical examination or test abnormality that would prevent study participation or place the subject at significant risk.
• •2. Subjects with unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.
• •3. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors.
• •4. Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Visit 2 and during the study.
• •5. Subjects who cannot discontinue systemic and/or topical therapies.
• •6. Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
• •7. Subjects with actively infected AD or any infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents
• •8. Known or suspected:
• •1. severe renal insufficiency or moderate to severe hepatic disorders (Child-Pugh B or C)
• •2. history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
• •3. hypersensitivity to component(s) of the investigational product
• •4. history of severe depression, suicidal ideation, Baseline/Screening C-SSRS indicative of suicidal ideation, whether lifetime or recent/current
• •9. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• •10. Subjects (12 to 17 years old, inclusive) with modified PHQ-A score ≥10 at Screening or Baseline visits.
• •11. Subjects (6 to 11 years old, inclusive) with a CDI-2 (parent report) raw score \>20 at Screening/Baseline
• •12. Subjects with a history of a major surgery within 4 weeks prior to Baseline/Visit 1 or subjects who have a major surgery planned during the study.
• •13. Subjects with prior exposure to ARQ-151
• •14. Subjects 3 to \<12 months old who were premature at birth
• •15. Subject is nursing and subject's mother requires high dose systemic steroids