- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05466578
Pre-approval Single-patient Expanded Access for Abrocitinib (PF-04965842)
November 13, 2023 updated by: Pfizer
Provide pre-approval single patient Expanded Access (compassionate use) of abrocitinib for patients with severe uncontrolled atopic dermatitis
Study Overview
Status
Available
Conditions
Intervention / Treatment
Detailed Description
In Expanded Access, treating physicians are the Sponsor.
Expanded Access requests from treating physicians may be submitted at www.pfizercares.com ; availability will depend on location/country.
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Description
Must have severe uncontrolled atopic dermatitis refractory to other available treatments
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
Collaborators
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
June 22, 2022
First Submitted That Met QC Criteria
July 19, 2022
First Posted (Actual)
July 20, 2022
Study Record Updates
Last Update Posted (Actual)
November 15, 2023
Last Update Submitted That Met QC Criteria
November 13, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B745
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.
Clinical Trials on Severe Uncontrolled Atopic Dermatitis
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Red Cross War Memorial Childrens HospitalUnknownSevere Atopic DermatitisSouth Africa
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Novartis PharmaceuticalsCompletedSevere Atopic Dermatitis
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Regeneron PharmaceuticalsSanofiCompletedModerate to Severe Atopic Hand and Foot DermatitisUnited States, Germany, Japan, Poland
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SanofiRegeneron PharmaceuticalsRecruitingModerate to Severe Atopic DermatitisCanada
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Beijing InnoCare Pharma Tech Co., Ltd.RecruitingModerate to Severe Atopic DermatitisChina
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Keymed Biosciences Co.LtdRecruitingModerate-to-severe Atopic DermatitisChina
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Galderma R&DRecruitingModerate-to-Severe Atopic DermatitisUnited States, Denmark, Hungary, Poland, Spain
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Shanghai Hengrui Pharmaceutical Co., Ltd.CompletedModerate to Severe Atopic DermatitisChina
Clinical Trials on abrocitinib
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PfizerActive, not recruitingAtopic DermatitisIndia
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Innovaderm Research Inc.Not yet recruiting
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PfizerActive, not recruitingDermatitis, AtopicChina, United States, Spain, Taiwan, Germany, Australia, Canada, Hungary, Korea, Republic of, Poland, Serbia, Bulgaria, Czechia, Japan, Latvia, United Kingdom, Belgium, Israel, Italy, Finland, Mexico, Romania, Slovakia, Argentina, Brazil, Chil... and more
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PfizerAvailableAtopic DermatitisTaiwan, United States, Australia, Austria, Belgium, Canada, Greece, Mexico, Netherlands, Russian Federation, Spain, Switzerland
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William DamskyYale University; PfizerActive, not recruiting
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National Institute of Diabetes and Digestive and...PfizerRecruitingDiabetes Mellitus, Type 1United States
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PfizerCompletedAtopic DermatitisSpain, Taiwan, United States, Korea, Republic of, Poland, Canada, Australia, Hungary, Germany, Latvia, Finland, Chile, Bulgaria, Slovakia, Italy
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Icahn School of Medicine at Mount SinaiRecruiting