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

Sponsor

Pfizer (Industry)

Overall Status

Available

CT.gov ID

NCT04564755

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: 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.

Study Design

Study Type:

Expanded Access

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cahaba Dermatology and Skin Health Center	Birmingham	Alabama	United States	35244
2	Antelope Valley Clinical Trials	Lancaster	California	United States	93534
3	Allergy & Asthma Care Center	Long Beach	California	United States	90808
4	ACRC Studies	San Diego	California	United States	92119
5	Palm Beach Dermatology	Delray Beach	Florida	United States	33484
6	Skin Care Research	Hollywood	Florida	United States	33021
7	L&C Professional Medical Research Institute	Miami	Florida	United States	33144
8	Sarasota Clinical Research	Sarasota	Florida	United States	34239
9	Precision Clinical Research	Sunrise	Florida	United States	33351
10	Dundee Dermatology	West Dundee	Illinois	United States	60118
11	Qualmedica Research, LLC	Evansville	Indiana	United States	47715
12	Bluegrass Allergy Research	Lexington	Kentucky	United States	40509
13	Respiratory Medicine Research Institute of Michigan, PLC	Ypsilanti	Michigan	United States	48197
14	Bexley Dermatology Research	Bexley	Ohio	United States	43209
15	Hightower Clinical Trial Services - Lam Dermatology	Norman	Oklahoma	United States	73072
16	Health Concepts	Rapid City	South Dakota	United States	57702
17	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Memphis	Tennessee	United States	38119
18	Center for Clinical Studies, LTD. LLP	Houston	Texas	United States	77004
19	Houston Medical Imaging	Houston	Texas	United States	77072
20	West Virginia Research Institute	Morgantown	West Virginia	United States	26505
21	Woden Dermatology	Phillip	Australian Capital Territory	Australia	2606
22	Royal North Shore Hospital	St Leonards	New South Wales	Australia	2065
23	The Skin Centre	Benowa	Queensland	Australia	4217
24	Sinclair Dermatology	Melbourne	Victoria	Australia	3995
25	Ordensklinikum Linz GmbH Elisabethinen	Linz	Oberösterreich	Austria	4020
26	Medizinische Universität Wien	Vienna	Wien	Austria	1090
27	Medical University of Vienna	Vienna		Austria	1090
28	Cliniques Universitaires Saint-Luc	Brussels		Belgium	1200
29	Universitair Ziekenhuis Gent	Gent		Belgium	9000
30	Grand Hôpital de Charleroi	Loverval		Belgium	6280
31	Dermatology Research Institute	Calgary	Alberta	Canada	T2J 7E1
32	DermEffects	London	Ontario	Canada	N6H 5L5
33	Lynderm Research Inc.	Markham	Ontario	Canada	L3P 1X3
34	SKiN Centre for Dermatology	Peterborough	Ontario	Canada	K9J 5K2
35	Centre de recherche Saint-Louis	Quebec		Canada	G1W 4R4
36	Centro de Dermatologia de Monterrey	Monterrey	Nuevo LEÓN	Mexico	64460
37	Universitair Medisch Centrum (UMCU) Utrecht	Utrecht		Netherlands	3584 CX
38	NRC Institute of Immunology FMBA of Russia	Moscow		Russian Federation	115522
39	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas de Gran Canaria	LAS Palmas	Spain	35010
40	Complejo Hospitalario Universitario de Pontevedra Centro de Especialidades de Mollabao	Pontevedra		Spain	36001
41	Consorcio Hospital General Universitario de Valencia	Valencia		Spain	46014
42	Universitätsspital Zürich	Zuerich	Zürich	Switzerland	8052
43	Universitätsspital Zürich	Zuerich	Zürich	Switzerland	8091
44	Inselspital, Universitätsklinik für Dermatologie	Bern		Switzerland	3010
45	Inselspital, Universitätsspital Bern (Radiology)	Bern		Switzerland	3010
46	University Hospital Geneva	Geneva 14		Switzerland	1211
47	Universitätsspital Zürich	Zürich		Switzerland	CH-8091
48	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung		Taiwan	807
49	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung		Taiwan	83301
50	National Cheng Kung University Hospital	Tainan		Taiwan	704
51	Taipei Veterans General Hospital	Taipei		Taiwan	112