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

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.

Available
Treatment IND/Protocol
Atopic Dermatitis

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

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years
Countries
Australia
Canada
Switzerland
United States
Locations

Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, 35244

Available

Antelope Valley Clinical Trials
Lancaster, California, 93534

Available

Allergy & Asthma Care Center
Long Beach, California, 90808

Available

ACRC Studies
San Diego, California, 92119

Available

Palm Beach Dermatology
Delray Beach, Florida, 33484

Available

Skin Care Research, LLC
Hollywood, Florida, 33021

Available

L&C Professional Medical Research Institute
Miami, Florida, 33144

Available

Sarasota Clinical Research
Sarasota, Florida, 34239

Available

Precision Clinical Research
Sunrise, Florida, 33351

Available

Dundee Dermatology
West Dundee, Illinois, 60118

Available

Qualmedica Research, LLC
Evansville, Indiana, 47715

Available

Mid West Xray Inc.
Evansville, Indiana, 47720

Available

Bluegrass Allergy Research
Lexington, Kentucky, 40509

Available

Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197

Available

Bexley Dermatology Research
Bexley, Ohio, 43209

Available

Hightower Clinical Trial Services - Lam Dermatology
Norman, Oklahoma, 73072

Available

Health Concepts
Rapid City, South Dakota, 57702

Available

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Memphis, Tennessee, 38119

Available

Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004

Available

Houston Medical Imaging
Houston, Texas, 77072

Available

West Virginia Research Institute
Morgantown, West Virginia, 26505

Available

Contacts

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

Pfizer CT.gov Call Center
Study Director
Pfizer

NCT Number
Keywords
atopic dermatitis
eczema
Expanded Access
MeSH Terms
Dermatitis, Atopic
Dermatitis
Eczema
Intervention Name
abrocitinib