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

NO_LONGER_AVAILABLE

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT04564755

Run by

Pfizer

Last updated by the study team

2024-10-29

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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

You may not qualify 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

Where it is running

• Antelope Valley Clinical Trials — Lancaster, California, United States
• Allergy & Asthma Care Center — Long Beach, California, United States
• Beach Allergy and Asthma Specialty Group, A Medical Corporation — Long Beach, California, United States
• ACRC Studies — San Diego, California, United States
• Palm Beach Dermatology — Delray Beach, Florida, United States
• Skin Care Research — Hollywood, Florida, United States
• L&C Professional Medical Research Institute — Miami, Florida, United States
• Sarasota Clinical Research — Sarasota, Florida, United States
• Precision Clinical Research — Sunrise, Florida, United States
• Dundee Dermatology — West Dundee, Illinois, United States
• Qualmedica Research, LLC — Evansville, Indiana, United States
• Bluegrass Allergy Research — Lexington, Kentucky, United States
• Respiratory Medicine Research Institute of Michigan, PLC — Ypsilanti, Michigan, United States
• Bexley Dermatology Research — Bexley, Ohio, United States
• Hightower Clinical Trial Services - Lam Dermatology — Norman, Oklahoma, United States
• Health Concepts — Rapid City, South Dakota, United States
• Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Memphis, Tennessee, United States
• Center for Clinical Studies, LTD. LLP — Houston, Texas, United States
• Houston Medical Imaging — Houston, Texas, United States
• West Virginia Research Institute — Morgantown, West Virginia, United States
• Woden Dermatology — Phillip, Australian Capital Territory, Australia
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• The Skin Centre — Benowa, Queensland, Australia
• Dr Rodney Sinclair Pty Ltd — Melbourne, Victoria, Australia
• Cahaba Dermatology and Skin Health Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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