Atopic DermatitisNCT04564755
Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis
A study testing abrocitinib in people with Atopic Dermatitis, run by Pfizer at 57 sites in 12 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- abrocitinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 57 sitesin 12 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
57 sites in 12 countries.
57 sites in 12 countries
United States21 sites
Bexley Dermatology Research
Bexley, Ohio, 43209
Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, 35244
Palm Beach Dermatology
Delray Beach, Florida, 33484
Qualmedica Research, LLC
Evansville, Indiana, 47715
Skin Care Research
Hollywood, Florida, 33021
Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004
Houston Medical Imaging
Houston, Texas, 77072
Antelope Valley Clinical Trials
Lancaster, California, 93534
Bluegrass Allergy Research
Lexington, Kentucky, 40509
Allergy & Asthma Care Center
Long Beach, California, 90808
Beach Allergy and Asthma Specialty Group, A Medical Corporation
Long Beach, California, 90808
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Memphis, Tennessee, 38119
L&C Professional Medical Research Institute
Miami, Florida, 33144
West Virginia Research Institute
Morgantown, West Virginia, 26505
Hightower Clinical Trial Services - Lam Dermatology
Norman, Oklahoma, 73072
Health Concepts
Rapid City, South Dakota, 57702
ACRC Studies
San Diego, California, 92119
Sarasota Clinical Research
Sarasota, Florida, 34239
Precision Clinical Research
Sunrise, Florida, 33351
Dundee Dermatology
West Dundee, Illinois, 60118
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197
Australia6 sites
The Skin Centre
Benowa, Queensland, 4217
Dr Rodney Sinclair Pty Ltd
Melbourne, Victoria, 3995
Sinclair Dermatology
Melbourne, Victoria, 3995
Paratus Clinical Research Woden
Philip, 2606
Woden Dermatology
Phillip, Australian Capital Territory, 2606
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Switzerland6 sites
Inselspital, Universitätsklinik für Dermatologie
Bern, 3010
Inselspital, Universitätsspital Bern (Radiology)
Bern, 3010
University Hospital Geneva
Geneva, 1211
Universitätsspital Zürich
Zurich, Canton of Zurich, 8052
Universitätsspital Zürich
Zurich, Canton of Zurich, 8091
Universitätsspital Zürich
Zurich, CH-8091
Canada5 sites
Dermatology Research Institute
Calgary, Alberta, T2J 7E1
DermEffects
London, Ontario, N6H 5L5
Lynderm Research Inc.
Markham, Ontario, L3P 1X3
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Centre de recherche Saint-Louis
Québec, G1W 4R4
Spain5 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, LAS Palmas, 35010
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Complejo Hospitalario Universitario de Pontevedra Centro de Especialidades de Mollabao
Pontevedra, 36001
Consorcio Hospital General Universitario de Valencia
Valencia, 46014
Belgium3 sites
Cliniques universitaires Saint-Luc
Brussels, 1200
Universitair Ziekenhuis Gent
Ghent, 9000
Grand Hôpital de Charleroi
Loverval, 6280
Greece3 sites
401 General Military Hospital of Athens
Athens, Attikí, 11525
University General Hospital "ATTIKON"
Athens, Attikí, 12462
"Ippokrateio" General Hospital of Thessaloniki interconnected with Hospital of Dermatology and Vener
Thessaloniki, Kentrikí Makedonía, 54643
Taiwan3 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, 83301
Taipei Veterans General Hospital
Taipei, 112
Austria2 sites
Medizinische Universität Wien
Vienna, State of Vienna, 1090
Medical University of Vienna
Vienna, 1090
Netherlands1 site
Universitair Medisch Centrum (UMCU) Utrecht
Utrecht, 3584 CX
About this study
Official title: 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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- abrocitinib
- Keywords
- atopic dermatitis, eczema, expanded access
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abrocitinibDrug
Participants will receive abrocitinib 100 mg or 200 mg orally once a day as directed by the investigator's clinical judgement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564755
- Sponsor's protocol ID
- B7451064
- Other IDs
- 2020-003610-12, JADE REAL
- Status last verified
- Oct 2024
- First submitted
- 21 Sep 2020
- Last updated
- 29 Oct 2024
- Results posted
- No
Publications
Chovatiya R, Zirwas M, Gooderham MJ, Bangert C, Sinclair R, de Bruin-Weller M, Weidinger S, Tsang C, McCarthy C, Selfridge A, Biswas P, Koppensteiner H, Feeney C, Ramaker S, Chan G. Simulating real-world abrocitinib use in atopic dermatitis: results from JADE REAL. J Dermatolog Treat. 2026 Dec;37(1):2712186. doi: 10.1080/09546634.2026.2712186. Epub 2026 Aug 7.
PubMed 42565345
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABROCITINIB EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADOLESCENTS AND ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
- ClinicalTrials.gov ID
- NCT04564755
- Acronym / sponsor ID
- B7451064
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, eczema, expanded access
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abrocitinibParticipants will receive abrocitinib 100 mg or 200 mg orally once a day as directed by the investigator's clinical judgement | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Derived from this study: PubMed 42565345Chovatiya R, Zirwas M, Gooderham MJ, Bangert C, Sinclair R, de Bruin-Weller M, Weidinger S, Tsang C, McCarthy C, Selfridge A, Biswas P, Koppensteiner H, Feeney C, Ramaker S, Chan G. Simulating real-world abrocitinib use in atopic dermatitis: results from JADE REAL. J Dermatolog Treat. 2026 Dec;37(1):2712186. doi: 10.1080/09546634.2026.2712186. Epub 2026 Aug 7.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
57 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abrocitinib in people with Atopic Dermatitis, run by Pfizer at 57 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Australia, Switzerland, Canada, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04564755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.