Abrocitinib Expanded Access Protocol in Adolescents & NCT04564755

Clinical Trial Details — Status: Available

Administrative data
NCT number	NCT04564755
Other study ID #	B7451064
Secondary ID	2020-003610-12JA
Status	Available
Phase
First received
Last updated

Study information
Verified date	May 2024
Source	Pfizer
Contact	Pfizer CT.gov Call Center
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries[@]pfizer.com
Is FDA regulated	No
Health authority
Study type	Expanded Access

Clinical 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 ineligible for participation in clinical studies with abrocitinib.

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.

Recruitment information / eligibility
Status	Available
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	All
Age group	12 Years and older
Eligibility	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 <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

Related Conditions & MeSH terms

Intervention

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

Locations
Country	Name	City	State
Australia	The Skin Centre	Benowa	Queensland
Australia	Dr Rodney Sinclair Pty Ltd	Melbourne	Victoria
Australia	Sinclair Dermatology	Melbourne	Victoria
Australia	Paratus Clinical Research Woden	Philip
Australia	Woden Dermatology	Phillip	Australian Capital Territory
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Austria	Medical University of Vienna	Vienna
Austria	Medizinische Universität Wien	Vienna	Wien
Belgium	Cliniques universitaires Saint-Luc	Brussels
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Grand Hôpital de Charleroi	Loverval
Canada	Dermatology Research Institute	Calgary	Alberta
Canada	DermEffects	London	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	Centre de recherche Saint-Louis	Quebec
Greece	401 General Military Hospital of Athens	Athens	Attikí
Greece	University General Hospital "ATTIKON"	Athens	Attikí
Greece	"Ippokrateio" General Hospital of Thessaloniki interconnected with Hospital of Dermatology and Vener	Thessaloniki	Kentrikí Makedonía
Mexico	Centro de Dermatologia de Monterrey	Monterrey	Nuevo LEÓN
Netherlands	Universitair Medisch Centrum (UMCU) Utrecht	Utrecht
Russian Federation	NRC Institute of Immunology FMBA of Russia	Moscow
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas de Gran Canaria	LAS Palmas
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Complejo Hospitalario Universitario de Pontevedra Centro de Especialidades de Mollabao	Pontevedra
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Switzerland	Inselspital, Universitätsklinik für Dermatologie	Bern
Switzerland	Inselspital, Universitätsspital Bern (Radiology)	Bern
Switzerland	University Hospital Geneva	Geneva 14
Switzerland	Universitätsspital Zürich	Zuerich	Zürich
Switzerland	Universitätsspital Zürich	Zuerich	Zürich
Switzerland	Universitätsspital Zürich	Zürich
Taiwan	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Taipei Veterans General Hospital	Taipei
United States	Bexley Dermatology Research	Bexley	Ohio
United States	Cahaba Dermatology and Skin Health Center	Birmingham	Alabama
United States	Palm Beach Dermatology	Delray Beach	Florida
United States	Qualmedica Research, LLC	Evansville	Indiana
United States	Skin Care Research	Hollywood	Florida
United States	Center for Clinical Studies, LTD. LLP	Houston	Texas
United States	Houston Medical Imaging	Houston	Texas
United States	Antelope Valley Clinical Trials	Lancaster	California
United States	Bluegrass Allergy Research	Lexington	Kentucky
United States	Allergy & Asthma Care Center	Long Beach	California
United States	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Memphis	Tennessee
United States	L&C Professional Medical Research Institute	Miami	Florida
United States	West Virginia Research Institute	Morgantown	West Virginia
United States	Hightower Clinical Trial Services - Lam Dermatology	Norman	Oklahoma
United States	Health Concepts	Rapid City	South Dakota
United States	ACRC Studies	San Diego	California
United States	Sarasota Clinical Research	Sarasota	Florida
United States	Precision Clinical Research	Sunrise	Florida
United States	Dundee Dermatology	West Dundee	Illinois
United States	Respiratory Medicine Research Institute of Michigan, PLC	Ypsilanti	Michigan

Sponsors *(1)*
Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States, Australia, Austria, Belgium, Canada, Greece, Mexico, Netherlands, Russian Federation, Spain, Switzerland, Taiwan,

See also
Status	Clinical Trial	Phase
Completed	`NCT05018806` - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis	Phase 2
Completed	`NCT04090229` - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis	Phase 1
Terminated	`NCT03847389` - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis	Phase 1/Phase 2
Active, not recruiting	`NCT05388760` - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)	Phase 2
Completed	`NCT05530707` - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer	N/A
Completed	`NCT02595073` - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis	Phase 3
Recruiting	`NCT05509023` - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)	Phase 2
Recruiting	`NCT05048056` - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis	Phase 2
Completed	`NCT04598269` - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis	Phase 2
Recruiting	`NCT03936335` - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn	`NCT03089476` - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy	N/A
Recruiting	`NCT05029895` - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated	`NCT03654755` - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis	Phase 2
Completed	`NCT04556461` - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function	Phase 2
Recruiting	`NCT04818138` - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort	N/A
Completed	`NCT03719742` - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer	N/A
Completed	`NCT05375955` - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.	Phase 2
Completed	`NCT03441568` - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control	N/A
Recruiting	`NCT06366932` - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models	Phase 4
Completed	`NCT03304470` - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis	Phase 2

External Links

To obtain contact information for a study center near you, click here.

Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Available

Administrative data

Study information