Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy

Exclusion Criteria

• •1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• •2. Subject has known or suspected allergic contact dermatitis of the hands and is unable to avoid exposure to the causative allergen or subjects with suspected or expected changes in irritant or allergen exposures from screening through the end of the study.
• •3. Subject has active skin infections of the hands.
• •4. Subject has a history or has current active psoriasis.
• •5. Subject has a history of eczema herpeticum within 12 months prior to screening, and/or a history of 2 or more episodes of eczema herpeticum in the past.
• •6. Subject has a history of skin disease or presence of skin condition.
• •7. Subject has a history of cancer prior to Day 1.
• •8. Subject has any clinically significant medical condition (including psychiatric condition) or physical/laboratory/vital signs abnormality.
• •9. Subject has a current or past medical history of conditions associated with thrombocytopenia, coagulopathy, or platelet dysfunction.
• •10. Subject has a current or recent clinically significant viral, bacterial, fungal, or parasitic infection.
• •11. Subject has a history of clinically significant heart disease.
• •12. Subject is ≥ 50 years old AND has a history of heart attack, other clinically significant heart problems, stroke, or blood clots (in the opinion of the investigator).
• •13. Presence of laboratory abnormalities at the screening visit.
• •14. Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1.
• •15. Subject has used any topical treatments that could have an impact on CHE within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, topical retinoids, crisaborole, calcineurin inhibitors, ruxolitinib, tars, bleach, bleach baths, antimicrobials, medical devices.
• •16. Subject has a known hypersensitivity to abrocitinib or its excipients.
• •17. Subject has a known history of clinically significant drug or alcohol abuse within 6 months prior to Day 1.