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

NCT04564755

No Longer AvailableN/A

Sponsor: Pfizer

Conditions: Atopic Dermatitis

Interventions: abrocitinib

Countries: United States, Australia, Austria, Belgium, Canada, Greece, Mexico, Netherlands

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.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: EXPANDED_ACCESS

Eligibility criteria
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
Locations (57)
  • Birmingham, Alabama, United States
  • Lancaster, California, United States
  • Long Beach, California, United States
  • Long Beach, California, United States
  • San Diego, California, United States
  • Delray Beach, Florida, United States
  • Hollywood, Florida, United States
  • Miami, Florida, United States
  • Sarasota, Florida, United States
  • Sunrise, Florida, United States
  • West Dundee, Illinois, United States
  • Evansville, Indiana, United States
  • Lexington, Kentucky, United States
  • Ypsilanti, Michigan, United States
  • Bexley, Ohio, United States
  • Norman, Oklahoma, United States
  • Rapid City, South Dakota, United States
  • Memphis, Tennessee, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Morgantown, West Virginia, United States
  • Phillip, Australian Capital Territory, Australia
  • St Leonards, New South Wales, Australia
  • Benowa, Queensland, Australia
  • Melbourne, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Philip, Australia
  • Vienna, State of Vienna, Austria
  • Vienna, Austria
  • Brussels, Belgium
  • + 27 more on CT.gov