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Keep this study
Lead
Pfizer
This is a multi-center expanded access protocol (EAP) for the treatment of up to approximately 500 adult and adolescent (defined as age \< 18 years) patients with moderate to severe atopic dermatitis for whom standard, approved medicated topical and systemic treatment options are inadequate and who would be suitable candidates for a trial of abrocitinib for potential treatment of moderate to severe atopic dermatitis. The study will also collect safety and exploratory efficacy data. Participants who meet the inclusion criteria and none of the exclusion criteria may be enrolled into the EAP to receive open-label oral treatment with abrocitinib.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
12 years of age or older
Clinical diagnosis of chronic atopic dermatitis for at least 6 months
Inadequate treatment options with available, approved medicated topical and systemic therapies for moderate to severe atopic dermatitis
Moderate to severe atopic dermatitis as indicated by at least one of the following: IGA ≥3; EASI ≥16
You may not be if
Medical, psychiatric, or laboratory abnormality that may increase the risk associated with study participation
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
Require treatment with prohibited medications during the study
Discontinued prior treatment with any systemic JAK inhibitor due to safety or tolerability issues
12 to \<18 years old without documented evidence of having received at least one dose of the varicella vaccine or without evidence of prior exposure to varicella zoster virus based on serological test
Pregnant or breastfeeding women or women of childbearing potential who are sexually active and unwilling to use contraception
Clareo Health | Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis