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
- Genetic Diseases, Inborn
- Immune System Diseases
- Hypersensitivity, Immediate
- Hypersensitivity
- Skin Diseases
- Skin Diseases, Genetic
- Skin Diseases, Eczematous
- Dermatitis
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Skin and Connective Tissue Diseases
- Dermatitis, Atopic
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- abrocitinib
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.