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

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ClinicalTrials.gov Identifier: NCT04564755
Expanded Access Status : Available
First Posted : September 25, 2020
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Atopic Dermatitis Drug: 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.

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: ABROCITINIB EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADOLESCENTS AND ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema


Intervention Details:
  • Drug: abrocitinib
    Participants will receive abrocitinib 100 mg or 200 mg orally once a day as directed by the investigator's clinical judgement

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564755


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 31 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04564755    
Other Study ID Numbers: B7451064
2020-003610-12 ( EudraCT Number )
JADE REAL ( Other Identifier: Alias Study Number )
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Keywords provided by Pfizer:
atopic dermatitis
eczema
expanded access
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases