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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04564755




Registration number
NCT04564755
Ethics application status
Date submitted
21/09/2020
Date registered
25/09/2020
Date last updated
6/05/2024

Titles & IDs
Public title
Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis
Scientific title
ABROCITINIB EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADOLESCENTS AND ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Secondary ID [1] 0 0
2020-003610-12
Secondary ID [2] 0 0
B7451064
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - abrocitinib

Treatment: Drugs: abrocitinib
Participants will receive abrocitinib 100 mg or 200 mg orally once a day as directed by the investigator's clinical judgement
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Available
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
The Skin Centre - Benowa
Recruitment hospital [4] 0 0
Dr Rodney Sinclair Pty Ltd - Melbourne
Recruitment hospital [5] 0 0
Sinclair Dermatology - Melbourne
Recruitment hospital [6] 0 0
Paratus Clinical Research Woden - Philip
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4217 - Benowa
Recruitment postcode(s) [4] 0 0
3995 - Melbourne
Recruitment postcode(s) [5] 0 0
2606 - Philip
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
South Dakota
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
West Virginia
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Austria
State/province [15] 0 0
Vienna
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussels
Country [17] 0 0
Belgium
State/province [17] 0 0
Gent
Country [18] 0 0
Belgium
State/province [18] 0 0
Loverval
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Greece
State/province [22] 0 0
Attikí
Country [23] 0 0
Greece
State/province [23] 0 0
Kentrikí Makedonía
Country [24] 0 0
Mexico
State/province [24] 0 0
Nuevo LEÓN
Country [25] 0 0
Netherlands
State/province [25] 0 0
Utrecht
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Moscow
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
Spain
State/province [28] 0 0
LAS Palmas
Country [29] 0 0
Spain
State/province [29] 0 0
Navarra
Country [30] 0 0
Spain
State/province [30] 0 0
Pontevedra
Country [31] 0 0
Spain
State/province [31] 0 0
Valencia
Country [32] 0 0
Switzerland
State/province [32] 0 0
Zürich
Country [33] 0 0
Switzerland
State/province [33] 0 0
Bern
Country [34] 0 0
Switzerland
State/province [34] 0 0
Geneva 14
Country [35] 0 0
Taiwan
State/province [35] 0 0
Kaohsiung
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04564755
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04564755