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

October 28, 2024 updated by: Pfizer

ABROCITINIB EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADOLESCENTS AND ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Philip, Australia, 2606
        • Paratus Clinical Research Woden
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Woden Dermatology
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Benowa, Queensland, Australia, 4217
        • The Skin Centre
    • Victoria
      • Melbourne, Victoria, Australia, 3995
        • Dr Rodney Sinclair Pty Ltd
      • Melbourne, Victoria, Australia, 3995
        • Sinclair Dermatology
  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medizinische Universität Wien
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Loverval, Belgium, 6280
        • Grand Hôpital de Charleroi
  • Canada
      • Quebec, Canada, G1W 4R4
        • Centre de Recherche Saint-Louis
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Dermatology Research Institute
    • Ontario
      • London, Ontario, Canada, N6H 5L5
        • DermEffects
      • Markham, Ontario, Canada, L3P 1X3
        • Lynderm Research Inc.
      • Peterborough, Ontario, Canada, K9J 5K2
        • SKiN Centre for Dermatology
  • Greece
    • Attikí
      • Athens, Attikí, Greece, 11525
        • 401 General Military Hospital of Athens
      • Athens, Attikí, Greece, 12462
        • University General Hospital "Attikon"
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, Greece, 54643
        • "Ippokrateio" General Hospital of Thessaloniki interconnected with Hospital of Dermatology and Vener
  • Mexico
    • Nuevo LEÓN
      • Monterrey, Nuevo LEÓN, Mexico, 64460
        • Centro de Dermatologia de Monterrey
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum (UMCU) Utrecht
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • NRC Institute of Immunology FMBA of Russia
  • Spain
      • Pontevedra, Spain, 36001
        • Complejo Hospitalario Universitario de Pontevedra Centro de Especialidades de Mollabao
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario de Valencia
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
    • LAS Palmas
      • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrin
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsklinik für Dermatologie
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsspital Bern (Radiology)
      • Geneva 14, Switzerland, 1211
        • University Hospital Geneva
      • Zürich, Switzerland, CH-8091
        • Universitatsspital Zurich
    • Zürich
      • Zuerich, Zürich, Switzerland, 8052
        • Universitatsspital Zurich
      • Zuerich, Zürich, Switzerland, 8091
        • Universitatsspital Zurich
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung, Taiwan, 83301
        • Chang Gung Memorial Hospital at Kaohsiung
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Cahaba Dermatology and Skin Health Center
    • California
      • Lancaster, California, United States, 93534
        • Antelope Valley Clinical Trials
      • Long Beach, California, United States, 90808
        • Allergy & Asthma Care Center
      • Long Beach, California, United States, 90808
        • Beach Allergy and Asthma Specialty Group, A Medical Corporation
      • San Diego, California, United States, 92119
        • ACRC Studies
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Palm Beach Dermatology
      • Hollywood, Florida, United States, 33021
        • Skin Care Research
      • Miami, Florida, United States, 33144
        • L&C Professional Medical Research Institute
      • Sarasota, Florida, United States, 34239
        • Sarasota Clinical Research
      • Sunrise, Florida, United States, 33351
        • Precision Clinical Research
    • Illinois
      • West Dundee, Illinois, United States, 60118
        • Dundee Dermatology
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Qualmedica Research, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Bluegrass Allergy Research
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Respiratory Medicine Research Institute of Michigan, plc
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Bexley Dermatology Research
    • Oklahoma
      • Norman, Oklahoma, United States, 73072
        • Hightower Clinical Trial Services - Lam Dermatology
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
    • Texas
      • Houston, Texas, United States, 77004
        • Center for Clinical Studies, LTD. LLP
      • Houston, Texas, United States, 77072
        • Houston Medical Imaging
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • West Virginia Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B7451064
  • 2020-003610-12 (EudraCT Number)
  • JADE REAL (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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