Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis

Pfizer

Status

Conditions: Atopic Dermatitis

Treatments: Drug: abrocitinib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04564755

2020-003610-12 (EudraCT Number)

JADE REAL (Other Identifier)

B7451064

Details and patient eligibility

About

This is a multi-center, expanded access protocol to provide access to the investigational product, abrocitinib, to adolescent and adult patients with moderate to severe atopic dermatitis who have inadequate treatment options with available and approved medicated topical and systemic therapies and who are otherwise ineligible for participation in clinical studies with abrocitinib.

Full description

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.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Not eligible for participation in any ongoing clinical trial of abrocitinib, including lack of access due to geographical limitations

Exclusion criteria

• 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