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

NCT04564755

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis
Brief Summary 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.
Detailed 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.
Study Type Expanded Access
Expanded Access Type Treatment IND/Protocol
Intervention Drug: abrocitinib
Participants will receive abrocitinib 100 mg or 200 mg orally once a day as directed by the investigator's clinical judgement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Temporarily not available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04564755
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020