Dermatitis, AtopicPhase 3JADE EXTENDNCT03422822
Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
A Phase 3 study testing Abrocitinib 100 mg and Abrocitinib 200 mg in people with Dermatitis, Atopic, run by Pfizer at 539 sites in 28 countries.
Trial summary
B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying parent study. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Abrocitinib 100 mg and Abrocitinib 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,166 participants
- Where
- 539 sitesin 28 countries
- Study dates
- 8 Mar 2018to 22 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.
- Male or female subjects of 12 years of age or older, at the time of informed consent and meets inclusion criterion for minimum body weight (if applicable) from qualifying Parent study. Adolescent subjects below the age of 18 years old (or country-specific age of majority) will only be enrolled in this study if instructed by the sponsor and approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects aged 18 years (or country-specific age of majority) and older will be enrolled.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Must have completed the full treatment period of a qualifying Parent study OR must have completed the full rescue treatment period of a qualifying Parent study (if applicable) OR must have completed the full open-label run-in period in B7451014 and did not meet the protocol-specified response criteria at Week 12.
- Female subjects who are of childbearing potential (which includes all female subjects aged 12 years and older, regardless of whether they have experienced menarche) must ot be intending to become pregnant, currently pregnant, or lactating. The following onditions apply:
- Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to allocation to treatment.
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- Female subjects of childbearing potential must agree to use a highly effective method of contraception (as per Section 4.4.1) for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
- For Czech Republic only, 5 b. is revised and 5 c. is added to require:
- Female subjects of childbearing potential 15 years of age who are at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
- Female subjects less than 15 years of age must not be sexually active, and abstinence per the below definition should be confirmed prior to enrollment. NOTE: Sexual abstinence, defined as completely and persistently refraining from all heterosexual intercourse (including during the entire period of risk associated with the study treatments) may obviate the need for contraception ONLY if this is the preferred and usual lifestyle of the subject.
- 6. Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure; or
- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential. 7. Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
- 8. Must agree to avoid use of prohibited medications throughout the duration of the study. Exclusion Criteria
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Currently have active forms of other inflammatory skin diseases, ie, not AD or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day -1 that would interfere with evaluation of atopic dermatitis or response to treatment.
- Discontinued from treatment (or rescue treatment period/open-label run-in period, if applicable) early in a qualifying Parent study OR triggered a discontinuation criterion at any point during the qualifying Parent study which in the opinion of the investigator, or sponsor, is an ongoing safety concern.
- Ongoing adverse event in the qualifying Parent study which in the opinion of the investigator, or sponsor, is an ongoing safety concern.
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
- There are also additional separate inclusion and exclusion criteria to assess eligibility specifically for the B7451015 MRI sub-study.
Who cannot join
None listed.
Trial locations and contacts
539 sites in 28 countries.
539 sites in 28 countries
United States156 sites
Emmaus Research Center, Inc.
Anaheim, California, 92804
Synexus Clinical Research US, Inc.
Anderson, South Carolina, 29621
Arlington Research Center, Inc.
Arlington, Texas, 76011
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, 70808
The University of Texas Health Science Center Houston
Bellaire, Texas, 77401
Bexley Dermatology Research
Bexley, Ohio, 43209
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, 35209
University of Alabama at Birmingham - Dermatology Research Clinic
Birmingham, Alabama, 35233
University of Alabama at Birmingham Hospital Outreach Lab
Birmingham, Alabama, 35233
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, 35244
The University of Alabama at Birmingham, Department of Dermatology
Birmingham, Alabama, 35294
Skin Care Research
Boca Raton, Florida, 33486
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)
Boston, Massachusetts, 02114
MetroBoston Clinical Partners, LLC
Brighton, Massachusetts, 02135
Renaissance Research and Medical Group, Inc
Cape Coral, Florida, 33991
Cary Dermatology Center, PA
Cary, North Carolina, 27511
Accellacare - Cary
Cary, North Carolina, 27518
MUSC SCTR Research Nexus Clinic and Laboratory
Charleston, South Carolina, 29425
Institute for Asthma and Allergy
Chevy Chase, Maryland, 20815
Portland Clinical Research dba Columbia Asthma & Allergy Clinic
Clackamas, Oregon, 97015
Clarkston Skin Research
Clarkston, Michigan, 48346
Ds Research
Clarksville, Indiana, 47129
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907
Colorado Springs Dermatology Clinic, PC
Colorado Springs, Colorado, 80910
Columbus Regional Research Institute
Columbus, Georgia, 31904
IACT Health
Columbus, Georgia, 31904
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134
Skin Research Institute
Coral Gables, Florida, 33146
Avant Research Associates LLC
Crowley, Louisiana, 70526
Menter Dermatology Research Institute
Dallas, Texas, 75246
Henry Ford Medical Center, New Center One
Detroit, Michigan, 48202
Moonshine Research Center, Inc.
Doral, Florida, 33166
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Onyx Clinical Research
Flint, Michigan, 48507
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
First OC Dermatology Research Inc
Fountain Valley, California, 92708
Summit Clinical Research, LLC
Franklin, Virginia, 23851
The Ohio State University Dermatology East
Gahanna, Ohio, 43230
Medication Management, LLC
Greensboro, North Carolina, 27408
Homestead Research Institute
Homestead, Florida, 33030
Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004
Marvel Research, LLC
Huntington Beach, California, 92647
Ventavia Research Group
Hurst, Texas, 76054
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Tilda Research Inc.
Irvine, California, 92612
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256
One Health Research Clinic Atlanta, LLC
Johns Creek, Georgia, 30097
C & R Research Services USA, Inc
Kendall, Florida, 33183
Forest Hills Dermatology Group
Kew Gardens, New York, 11415
Pace Dermatology Associates
Lakewood, Washington, 98499
Beach Allergy and Asthma Specialty Group, A Medical Corporation
Long Beach, California, 90808
Keck School of Medicine of University of Southern California
Los Angeles, California, 90033
Wallace Medical Group, Inc
Los Angeles, California, 90056
Skin Sciences, PLLC
Louisville, Kentucky, 40217
Dermatologic Surgery Specialists, PC
Macon, Georgia, 31217
Velocity Clinical Research, Medford
Medford, Oregon, 97504
Tanenbaum Dermatology Center
Memphis, Tennessee, 38117
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Clinical Trials Solutions
Miami, Florida, 33126
Global Health Clinical Trials Corp
Miami, Florida, 33135
Baumann Cosmetic and Research Institute
Miami, Florida, 33137
Suncoast Research Associates
Miami, Florida, 33144
La Salud Research Clinic, Inc.
Miami, Florida, 33155
Nicklaus Children's Hospital
Miami, Florida, 33155
South Miami Medical & Research Group, Inc.
Miami, Florida, 33155
Ciocca Dermatology, PA
Miami, Florida, 33173
Miami Dermatology & Laser Research, LLC
Miami, Florida, 33173
INTERMED Medical Research Center, Inc
Miami, Florida, 33175
Suncoast Research Associates
Miami, Florida, 33184
Savin Medical Group LLC
Miami Lakes, Florida, 33014
Wellness Clinical Research, LLC
Miami Lakes, Florida, 33016
Children's Hospital of Wisconsin Investigational Drug Service
Milwaukee, Wisconsin, 53226
Children's Hospital of Wisconsin Translational Research Unit
Milwaukee, Wisconsin, 53226
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402
Allergy & Asthma Associates of Southern California dba Southern California Research
Mission Viejo, California, 92691
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130
ASR, LLC
Nampa, Idaho, 83687
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Virginia Clinical Research, Inc
Norfolk, Virginia, 23502
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, 23502
Fort Norfolk Diagnostic Center
Norfolk, Virginia, 23510
Midwest Allergy Sinus Asthma, SC
Normal, Illinois, 61761
Dermatology Specialists, Inc.
Oceanside, California, 92056
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Newton Clinical Research
Oklahoma City, Oklahoma, 73120
Skin Specialists PC
Omaha, Nebraska, 68144
Park Avenue Dermatology
Orange Park, Florida, 32073
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
AdventHealth Orlando
Orlando, Florida, 32803
AdventHealth Pediatric Dermatology Orlando
Orlando, Florida, 32803
Advent Health Orlando - Investigational Drug Services
Orlando, Florida, 32804
Outpatient Services Center - AdventHealth Orlando
Orlando, Florida, 32804
Pediatric Outpatient Procedures and Sedation
Orlando, Florida, 32804
Accel Research Sites - Nona Pediatric Center
Orlando, Florida, 32829
Kansas City Dermatology, PA
Overland Park, Kansas, 66215
Qualmedica Research, LLC.
Owensboro, Kentucky, 42301
Owensboro Dermatology Associates
Owensboro, Kentucky, 42303
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
Paddington Testing Co, Inc.
Philadelphia, Pennsylvania, 19103
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Oregon Medical Research Center
Portland, Oregon, 97201
Oregon Health & Science University
Portland, Oregon, 97239
M3-Wake Research, Inc.
Raleigh, North Carolina, 27612
Health Concepts
Rapid City, South Dakota, 57702
Mayo Clinic
Rochester, Minnesota, 55905
UR Dermatology Clinical Trials Unit at College Town
Rochester, New York, 14620
Investigational Drug Service
Rochester, New York, 14642
DermAssociates, LLC
Rockville, Maryland, 20850
Peninsula Headlands LLC
Rolling Hills Estates, California, 90274
UC Davis Health
Sacramento, California, 95816
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
MedDerm Associates
San Diego, California, 92103
University of California San Diego Dermatology
San Diego, California, 92122
Synergy Dermatology
San Francisco, California, 94132
San Luis Dermatology and Laser Clinic
San Luis Obispo, California, 93405
Southern California Dermatology, Inc.
Santa Ana, California, 92701
Wolverine Clinical Trials, Llc
Santa Ana, California, 92705
Mosaic Dermatology
Santa Monica, California, 90403
Clinical Science Institute
Santa Monica, California, 90404
Meridian Clinical Research
Savannah, Georgia, 31406
Dermatology Associates of Seattle
Seattle, Washington, 98101
Carolina Research Center, Inc.
Shelby, North Carolina, 28150
NorthShore University HealthSystem - Dermatology
Skokie, Illinois, 60077
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie, Illinois, 60077
The South Bend Clinic Center for Research
South Bend, Indiana, 46617
Dermatology Specialists of Spokane
Spokane, Washington, 99202
Principle Research Solutions
Spokane, Washington, 99204
Saint Louis University Dermatology
St Louis, Missouri, 63104
Olympian Clinical Research
St. Petersburg, Florida, 33709
MultiCare Allenmore Hospital
Tacoma, Washington, 98405
Multicare Institute for Research and Innovation
Tacoma, Washington, 98405
Pace Dermatology Associates
Tacoma, Washington, 98405
Clinical Research Trials of Florida, Inc.
Tampa, Florida, 33607
Clinical Research Trials of Florida
Tampa, Florida, 33607
ForCare Clinical Research
Tampa, Florida, 33613
University of South Florida; Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, 33613
Olympian Clinical Research
Tampa, Florida, 33615
Revival Research Institute, LLC
Troy, Michigan, 48084
Somerset Skin Centre
Troy, Michigan, 48084
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
Center for Clinical Studies, LTD.LLP
Webster, Texas, 77598
Henry Ford Medical Center - Farmington Road
West Bloomfield, Michigan, 48322
Dundee Dermatology
West Dundee, Illinois, 60118
Integrated Clinical Research
West Palm Beach, Florida, 33406
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162
PMG Research of Wilmington LLC
Wilmington, North Carolina, 28411
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28411
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
Winston-Salem Dermatology and Surgery Center, PLLC
Winston-Salem, North Carolina, 27103
Poland57 sites
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.
Bialystok, 15-453
KLIMED Marek Klimkiewicz
Bialystok, 15-704
Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny i Alergologiczny
Bydgoszcz, 85-650
DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gębska
Chorzów, 41-500
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, 42-202
Uniwersyteckie Centrum Kliniczne Klinika Dermatologii, Wenerologii i Alergologii
Gdansk, 80-214
Neutrum Lekarze M. Hlebowicz i Partnerzy Spolka Partnerska
Gdansk, 80-462
Szpital Sw. Wojciecha
Gdansk, 80-462
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, 81-537
MCBK
Grodzisk Mazowiecki, 05-825
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, 40-040
MULTIKLINIKA Salute Sp. z o.o.
Katowice, 40-123
Silmedic Sp. z o.o., Oddzial w Katowicach
Katowice, 40-282
Care Clinic Centrum Medyczne
Katowice, 40-568
Centrum Medyczne Angelius Provita
Katowice, 40-611
Pro Familia Altera Sp. z o.o.
Katowice, 40-648
Gabinet Dermatologiczny Beata Krecisz
Kielce, 25-217
Malopolskie Centrum Kliniczne
Krakow, 30-149
Centrum Badan Klinicznych JCI
Krakow, 30-348
Centrum Medyczne Plejady
Krakow, 30-363
Centrum Nowoczesnych Terapii "DOBRY LEKARZ" sp. z o.o.
Krakow, 31-011
AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc
Krakow, 31-302
Centrum Medyczne Promed
Krakow, 31-411
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, 31-501
Prywatna Praktyka Lekarska - Adam Smialowski INTERMED KSAWEROW
Ksawerów, 95-054
NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi
Lodz, 90-265
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, 90-338
Osrodek badan klinicznych AppleTree Clinics
Lodz, 90-349
Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
Lodz, 90-436
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362
NZOZ "Med-Laser" Borzecki Spolka Jawna
Lublin, 20-406
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, 27-400
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, 60-702
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
Poznan, 60-848
Gabinety Lekarskie Rivermed
Poznan, 61-441
LIFT-MED Spolka Akcyjna
Rybnik, 44-200
Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina, Klinika Dermatologii
Rzeszów, 35-055
EMED Centrum Uslug Medycznych Ewa Smialek
Rzeszów, 35-205
Andrzej Krolicki, Tomasz Kochanowski "Laser Clinic" S.C.
Szczecin, 70-332
Twoja Przychodnia Szczecinskie Centrum Medyczne
Szczecin, 71-500
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
Tarnów, 33-100
MICS Centrum Medyczne Warszawa
Warsaw, 00-874
Centrum Medyczne AMED
Warsaw, 01-518
MTZ Clinical Research Powered by Pratia
Warsaw, 02-172
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
Warsaw, 02-507
RCMed Oddzial Warszawa
Warsaw, 02-657
Carpe Diem Centrum Medycyny Estetycznej
Warsaw, 02-661
REUMATIKA - "Centrum Reumatologii" NZOZ 2
Warsaw, 02-665
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, 02-672
ETG Warszawa
Warsaw, 02-793
Klinika Ambroziak Sp. z o.o.
Warsaw, 02-953
Wojskowy Instytut Medyczny, Klinika Dermatologiczna
Warsaw, 04-141
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
Wroclaw, 50-220
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, 50-381
Lukasz Matusiak "4Health"
Wroclaw, 50-566
Centrum Medyczne Oporow
Wroclaw, 52-416
Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii
Zabrze, 41-800
Canada41 sites
CCA Medical Research
Ajax, Ontario, L1S 7K8
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1
Dermatology Research Institute
Calgary, Alberta, T1Y0B4
Dermatology Research Institute
Calgary, Alberta, T2J7E1
Beacon Dermatology
Calgary, Alberta, T3E 0B2
Clinique de Radiologie du Saguenay Enr.
Chicoutimi, Quebec, G7H 6B9
Intermed groupe santé
Chicoutimi, Quebec, G7H 7Y8
Stratica Medical
Edmonton, Alberta, T5K 1X3
Alberta Dermasurgery Centre
Edmonton, Alberta, T6G 1C3
Kingsway Clinical Research
Etobicoke, Ontario, M8X 1Y9
Medicor Research Inc
Greater Sudbury, Ontario, P3C 1X3
Sudbury Skin Clinique
Greater Sudbury, Ontario, P3C 1X8
Derm Effects
London, Ontario, N6H 5L5
Lynderm Research Inc.
Markham, Ontario, L3P 1X2
DermEdge Research
Mississauga, Ontario, L4Y 4C5
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5
Oshawa Clinic Dermatology Trials
Oshawa, Ontario, L1H 1B9
Dermatology Ottawa Research Centre
Ottawa, Ontario, K2C 3N2
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec, Quebec, G1V 4X7
Centre de Recherche Saint-Louis inc.
Québec, G1W 4R4
CARE Clinic Ltd
Red Deer, Alberta, T4P-1K4
Dr. Rachel Asiniwasis, Medical Professional Corp.
Regina, Saskatchewan, S4V1R9
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, L4C 9M7
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8
Karma Clinical Trials, Inc.
St. John's, Newfoundland and Labrador, A1A 4Y3
Dr. Chih-ho Hong Medical Inc
Surrey, British Columbia, V3R 6A7
North York Research Inc.
Toronto, Ontario, M2N3A6
Toronto Research Centre
Toronto, Ontario, M3H5Y8
Research Toronto
Toronto, Ontario, M4W 2N4
AvantDerm
Toronto, Ontario, M5A 3R6
Manna Research Inc.(Toronto)
Toronto, Ontario, M9W 4L6
University of British Columbia Department of Dermatology and Skin Science
Vancouver, British Columbia, V5Z 4E8
Pacific Dermaesthetics Inc.
Vancouver, British Columbia, V6H4E1
K.Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4
XLR8 Medical Research Inc.
Windsor, Ontario, N8T 1E6
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
Germany28 sites
Dermazentrum Augsburg
Augsburg, 86179
Licca Clinical Research Institute
Augsburg, 86179
Fachklinik Bad Bentheim
Bad Bentheim, 48455
Charite-Universitaetsmedizin Berlin
Berlin, 10117
Hautzentrum Friedrichshain Studien
Berlin, 10247
Rothhaar Studien GmbH
Berlin, 10783
ISA GmbH
Berlin, 10789
Klinikum Bielefeld Rosenhoehe
Bielefeld, 33647
Universitaetsklinikum Bonn
Bonn, 53105
Klinische Forschung Dresden GmbH
Dresden, 01069
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
Dresden, 01307
Universitätsklinikum Erlangen
Erlangen, 91054
IKF Pneumologie GmbH & Co KG; Institut für klinische Forschung
Frankfurt, 60596
SRH Wald-Klinikum Gera GmbH
Gera, 07548
Klinische Forschung Hamburg GmbH
Hamburg, 20253
MENSINGDERMA research GmbH
Hamburg, 22391
Medizinische Hochschule Hannover
Hanover, 30625
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105
Praxis Dr. med. Beate Schwarz
Langenau, 89129
Velocity Clinical Research Germany GmbH
Leipzig, 04103
Universitaetsklinikum Schleswig-Holstein, Campus Luebeck
Lübeck, 23538
Dermatologische Gemeinschaftspraxis
Mahlow, 15831
Dermatologische Gemeinschaftspraxis Dres. Quist
Mainz, 55128
Universitätsklinikum Marburg
Marburg, 35043
Ludwig-Maximilians-University Munich
Munich, 80337
University of Muenster
Münster, 48149
Klinische Forschung Schwerin GmbH
Schwerin, 19055
Hautaerztliche Gemeinschaftspraxis Dres. Leitz und Kollegen
Stuttgart, 70178
China25 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
The second Xiangya Hospital,Central South University
Changsha, Hunan, 410011
The Third Xiangya Hospital of Central South University, Dermatological department
Changsha, Hunan, 410013
The Second Affiliated Hospital of Army Medical University,PLA
Chongqing, 400037
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, 350005
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510630
The First Affiliated Hospital of Zhejiang University School of Medicine/Dermatology and STD Dept
Hangzhou, Zhejiang, 310003
Hangzhou Third Hospital
Hangzhou, Zhejiang, 310009
The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept
Hangzhou, Zhejiang, 310009
Zhejiang Provincial People's Hospital/Dermatology Department
Hangzhou, Zhejiang, 310014
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016
Jinan Central Hospital
Jinan, Shandong, 250013
Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin
Jinan, Shandong, 250022
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, 330000
The First Affiliated Hospital With Nanjing University
Nanjing, Jiangsu, 210000
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Dermatology Department, Shanghai Changzheng Hospital
Shanghai, 200003
Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology
Shanghai, 200092
Shanghai Dermatology Hospital
Shanghai, 200443
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, 518053
Tianjin Medical University General Hospital, Dermatological Department
Tianjin, Tianjin Municipality, 300052
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Czechia21 sites
Lekarna Pod Kankem
Kunta Hora, 284 01
Kozni ambulance Kutna Hora, s.r.o
Kutná Hora, 28401
Dermamedica S.R.O.
Náchod, 547 01
Lekarna U Stribrneho orla (Pharmacy)
Náchod, 547 01
CCR Ostrava, s.r.o.
Ostrava, 702 00
Lekarna Rezidence Nova Karolina
Ostrava, 702 00
Apavar Lekarna
Ostrava, 70200
Lekarna Fakultni Nemocnice Ostrava
Ostrava - Poruba, 708 52
Fakultni Nemocnice Ostrava, Kozni oddeleni
Ostrava - Poruba, 70852
BENU Lekarna
Pardubice, 530 02
PRATIA Pardubice a.s.
Pardubice, 530 02
Lekarna, Nemocnice Pardubickeho kraje, a.s. , Pardubicka nemocnice
Pardubice, 532 03
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
Pardubice, 53203
Lekarna Pod Platany (Pharmacy)
Prague, 101 00
Prof. MUDr.Petr Arenberger, DrSc. MBA
Prague, 11000
Lekarna U Spasitele
Prague, 12800
PRATIA Prague s.r.o.
Prague, 130 00
Dermatovenerologicka ambulance
Svitavy, 56802
Lekarna na Hranicni (Pharmacy)
Svitavy, 56802
Krajska zdravotni a.s., Masarykova nemocnice o.z.
Ústí nad Labem, 401 13
Lekarna Masarykovy nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, 401 13
Spain20 sites
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, 28922
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau Servicio de Dermatologia
Barcelona, 08041
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, 08950
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, LAS Palmas, 35010
Hospital Universitario de La Princesa
Madrid, 28006
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital del Nino Jesus
Madrid, 28009
Hospital Universitario 12 de octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, Madrid, 28222
Centro de Especialidades Mollabao (Area Sanitaria de Pontevedra e O Salnes)
Pontevedra, 36001
Hospital de Montecelo
Pontevedra, 36071
Hospital Universitario Virgen de la Macarena
Seville, 41009
Consorcio Hospital General Universitario de Valencia
Valencia, 46014
Hospital Universitario y Politecnico La Fe
Valencia, 46026
Hospital Universitario Miguel Servet
Zaragoza, 50009
United Kingdom18 sites
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, S75 2EP
MAC Clinical Research
Blackpool, FY2 0JH
University Hospital Bristol NHS Foundation Trust
Bristol, BS2 8HW
MAC Clinical Research
Cannock, WS11 0BN
Accellacare Warwickshire
Coventry, CV3 4FJ
West Glasgow Ambulatory Care Hospital
Glasgow, G3 8SJ
Royal free London NHS Foundation Trust
London, Greater London, NW3 2QG
Guy's Hospital-Guy's and St Thomas NHS Foundation Trust
London, SE1 9RT
MAC Clinical Research Ltd
Manchester, M13 9NQ
Accellacare North London
Northwood, Middlesex, HA6 2RN
MeDiNova South London Quality Research Site
Orpington, KENT, BR5 3QG
Accellacare South London
Orpington, BR5 3QG
Plymouth Hospitals NHS Trust, Derriford Hospital
Plymouth, Devon, PL6 8DH
Sheffield Children's NHS Foundation Trust
Sheffield, South Yorkshire, S10 2TH
Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital
Sheffield, South Yorkshire, S5 7AU
Accellacare Yorkshire
Shipley, BD18 3SA
Medinova Research
Wokingham, Berkshire, RG40 1XS
MeDiNova West London Quality Research Sites
Wokingham, Berkshire, RG40 1XS
Mexico17 sites
Derma Norte del Bajio S.C.
Aguascalientes, 20127
Centro de Investigacion Integral MEDIVEST, S.C.
Chihuahua City, 31203
Servicios Hospitalarios de Mexico S.A. de C.V. (Hospital Ángeles Chihuahua)
Chihuahua City, 31238
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, 54769
JM Research SC
Cuernavaca, Morelos, 62290
Hospital Infantil de Mexico Federico Gomez
Del. Cuauhtemoc, Mexico City, 06720
Unidad de Atención Médica e Investigación en Salud
Mérida, Yucatán, 97000
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
Mérida, Yucatán, 97130
Hospital de Jesus, I.A.P.
Mexico City, 06090
Cryptex Investigación Clínica, S.A. de C.V.
Mexico City, 06100
Arke Estudios Clinicos Sa De Cv
Mexico City, 06700
Trials in Medicine S.C.
Mexico City, 06700
Centro de Dermatologia de Monterrey
Monterrey, Nuevo León, 64460
Eukarya Pharmasite S.C.
Monterrey, 64718
SMIQ, S. de R. L. de C.V.
Querétaro, 76070
Clinical Research Institute S.C.
Saltillo, Coahuila, 25020
Sociedad de Metabolismo y Corazon S.C.
Veracruz, 91900
Australia16 sites
The Skin Centre
Benowa, Queensland, 4217
Eastern Health - Box Hill Hospital
Box Hill, Victoria, 3128
Emeritus Research
Camberwell, VIC 3124
North Eastern Health Specialists
Campbelltown, South Australia, 5074
Skin Health Institute Inc.
Carlton, Victoria, 3053
Sinclair Dermatology
East Melbourne, Victoria, 3002
St George Dermatology & Skin Cancer Centre
Kogarah, New South Wales, 2217
Australian Clinical Research Network
Maroubra, New South Wales, 2035
Royal Melbourne Hospital
Parkville, Victoria, 3050
The Royal Children's Hospital
Parkville, Victoria, 3052
Royal Melbourne Hospital
Parkville, 3052
Woden Dermatology
Phillip, Australian Capital Territory, 2606
Royal North Shore Hospital
Saint Leonards NSW, 2065
Royal North Shore Hospital
St Leonards, New South Wales, 2065
The Skin Hospital
Westmead, New South Wales, 2145
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102
Japan16 sites
Iidabashi Skin Clinic
Chiyoda-ku, Tokyo, 102-0072
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031
Sumire Dermatology Clinic
Edogawa-ku, Tokyo, 133-0052
Hoshikuma Dermatology・Allergy Clinic
Fukuoka, 814-0171
Matsuda Tomoko Dermatological Clinic
Fukuoka, 819-0167
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588
Kawashima Dermatology Clinic
Ichikawa, Chiba, 272-0033
Noguchi Dermatology Clinic
Kamimashiki-gun, Kumamoto, 861-3106
Dermatology Shimizu Clinic
Kobe, Hyōgo, 657-0846
Matsuyama Dermatology Clinic
Nakano-ku, Tokyo, 165-0026
Yoshioka Dermatology Clinic
Neyagawa, Osaka, 572-0838
Takagi Dermatological Clinic
Obihiro, Hokkaido, 080-0013
Sanrui Hifuka
Saitama, 330-0854
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, 593-8324
Tokyo Medical University Hospital
Shinjyuku-ku, Tokyo, 160-0023
Queen's square Medical Facilities Queen's square Dermatology and Allergology
Yokohama, Kanagawa, 220-6208
Hungary15 sites
Clinexpert Kft.
Budapest, 1033
SE AOK Bor, Nemikortani es Boronkologiai Klinika
Budapest, 1085
Bp. Főváros XIX. Kerület Önkormányzat Kispesti Eü. Intézete
Budapest, 1195
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
CRU Hungary Kft.
Encs, 3860
Bugát Pál Kórház, Bőrgyógyászati Szakrendelés
Gyöngyös, 3200
Trial Pharma Kft.
Győr, 9026
Synexus Magyarország Egészségügyi Szolgáltató Kft. Synexus Gyula DRS
Gyula, 5700
Trial Pharma Kft.
Kaposvár, 7400
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Gyermek Gasztroenterológia II. emelet
Miskolc, 3526
Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-,Nemikortani es Onkodermatologiai Klinika
Pécs, 7632
Trial Pharma Kft.
Püspökladány, 4150
Szegedi Tudomanyegyetem Szent-Györgyi Albert
Szeged, 6720
ALLERGO-DERM BAKOS Kft.
Szolnok, 5000
Medmare Bt
Veszprém, 8200
Russia14 sites
SBIH "Chelyabinsk Regional Clinical Dermatovenerology dispensary"
Chelyabinsk, 454048
Limited Liability Company "Medical Center "Rheuma-Med"
Kemerovo, 650070
Clinic of FSBEI HE Kirov SMU MOH Russia
Kirov, 610014
FSBI "State Research Centre of Dermatovenereology and Cosmetology" MoH RF
Moscow, 107076
NRC Institute of Immunology FMBA of Russia
Moscow, 115522
SBI RR "Skin and Venereal Dispensary"
Rostov-on-Don, 344007
SBI RR "Regional Clinical Skin and Veneral Dispensary"
Ryazan, 390046
LLC "Pierre Wolkenstein Clinic of Skin Diseases"
Saint Petersburg, 191123
Vitiligo center
Saint Petersburg, 191123
FSBEI HE "St. Petersburg State Pediatric Medical University" MoH RF
Saint Petersburg, 194100
Limited Liability Company "Sanavita"
Saint Petersburg, 194214
"Medical Research Institute", LLC
Saint Petersburg, 196084
FSBEI HE I.P.Pavlov SPbSMU MOH Russia
Saint Petersburg, 197022
RSBIH "Smolensk Regional Clinical Hospital"
Smolensk, 214018
Bulgaria13 sites
MHAT Dobrich AD
Dobrich, 9300
MC Asklepii" OOD
Dupnitsa, 2600
MHAT ''Dr. Tota Venkova'' AD
Gabrovo, 5300
"Acibadem City Clinic MHAT Tokuda" EAD
Sofia, 1407
"DCC Aleksandrovska" EOOD
Sofia, 1431
"DCC Fokus-5-Medical Establishment for OutpatientCare"EOOD
Sofia, 1463
Military Medical Academy MHAT Sofia
Sofia, 1606
Dermatology Clinic "Sofia" - group practice for specialized outpatient medical care
Sofia, 1756
"Mc Synexus Sofia" Eood
Sofia, 1784
ACIBADEM City Clinic Diagnostic-Consultative Center EOOD
Sofia, 1784
Medical Center Synexus Sofia EOOD-branch Stara Zagora
Stara Zagora, 6000
"ACIBADEM City Clinic Medical Center Varna" EOOD
Varna, 9000
"DCC Mladost-M Varna" OOD
Varna, 9000
South Korea12 sites
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14584
Kyungpook National University Hospital
Daegu, 41944
Chungnam National University Hospital CNUH
Daejeon, 35015
Chonnam National University Hospital
Gwangju, 61469
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 21431
Inha University Hospital
Incheon, 22332
Korea University Anam Hospital
Seoul, 02841
Severance Hospital, Yonsei Univ. Health System
Seoul, 03722
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Chung-Ang University Hospital
Seoul, 06973
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Slovakia9 sites
Narodny ustav detskych chorob
Bratislava, 833 40
BeneDerma s.r.o.
Bratislava, 841 02
Derma therapy spol. s.r.o, Dermatovenerologicka ambulancia
Bratislava, 85101
Summit Clinical Research, s.r.o.
Bratislava - Mestská Cast Nove Mesto, 831 01
SKINKLINIK s.r.o.
Bratislava- Mestská Časť Nové Mesto, 83101
Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica, Kozna ambulancia
Kosice-Saca, 040 15
Derma-beauty, s.r.o., Dermatovenerologicka ambulancia
Nitra, 949 01
Fakultna nemocnica s poliklinikou Nove Zamky, Dermatovenerologicka klinika
Nové Zámky, 940 34
SANARE spol.s.r.o.
Svidník, 089 01
Taiwan9 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 23561
Chung Shan Medical University Hospital
Taichung, 402
Taichung Veterans General Hospital
Taichung, 40705
National Cheng-Kung University Hospital
Tainan, 704
Taipei Veterans General Hospital
Taipei, Taiwan (r.o.c), 11217
National Taiwan University Hospital
Taipei, 100
Mackay Memorial Hospital
Taipei, 10449
Chang Gung Memorial Hospital Linkou Branch
Taoyuan City, 333
Brazil8 sites
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903/90035-003
Associacao dos Funcionarios Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, 90160-093
Instituto de Dermatologia e Estética do Brasil LTDA
Rio de Janeiro, Rio de Janeiro, 22470-220
IBPClin Pesquisa Clinica
Rio de Janeiro, 20241-180
Fundacao do ABC - Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-870
Tecnolab Medicina Diagnostica
Santo André, São Paulo, 09070-230
Pesquisare Saude S/S Ltda
Santo André, São Paulo, 09080-110
Tecnolab - Unidade Matriz
São Bernardo do Campo, São Paulo, 09750-670
Italy8 sites
AOU Policlinico Sant'Orsola Malpighi
Bologna, BO, 40138
Universita degli Studi G. D'Annunzio -CeSi-MeT
Chieti, CH, 66100
Ospedale Policlinico San Martino
Genova, GE, 16132
Istituto Clinico Humanitas IRCSS - UOC di Dermatologia
Milan, 20089
ASST Fatebenefratelli Sacco
Milan, 20157
AOU Policlinico di Modena Struttura complessa di Dermatologia
Modena, MO, 41124
IFO lstituto Dermatologico San Gallicano IRCCS
Roma, 00144
Universita del Sacro Cuore, Policlinico Agostino Gemelli, Istituto Di Dermatologia
Rome, 00168
Latvia7 sites
Riga 1st Hospital, Clinic of Dermatology and STD
Riga, LV - 1001
Aesthetic dermatology clinic of Prof. J. Kisis
Riga, LV-1003
Health Centre 4 Ltd. Diagnostics Centre
Riga, LV-1003
Childrens Clinical University Hospital State SLLC
Riga, LV-1004
Health and Aesthetics Ltd
Riga, LV-1009
Health Centre 4 Ltd, Dermatology Clinics
Riga, LV-1013
Outpatient Clinic Of Ventspils
Ventspils, LV3601
Argentina6 sites
CINME Centro de Investigaciones Metabolicas
C.a.b.a, C1027AAP
Psoriahue Medicina Interdisciplinaria
C.a.b.a., C1425DKG
CONEXA Investigación Clínica S.A.
CABA, Buenos Aires, C1012AAY
Framingham Centro Medico
La Plata, Buenos Aires, B1902COS
Hospital Universitario Austral
Pilar, Buenos Aires, B1629ODT
Servicio de Investigacion de Patolog-ias Alergicas del Instituto ABC - Rosario
Rosario, Santa Fe Province, 2000
Chile6 sites
Centro Medico SkinMed Limitada
Santiago, Santiago Metropolitan, 7580206
Clinica Dermacross S.A.
Santiago, Santiago Metropolitan, 7640881
CEC Spa
Santiago, Santiago Metropolitan, 7750495
MIRES (M Y F Estudios Clínicos Limitada)
Santiago, Santiago Metropolitan, 7750495
Hospital Clinico Universidad de Chile
Santiago, Santiago Metropolitan, 8380456
Centro Internacional de Estudios Clinicos - CIEC
Santiago, Santiago Metropolitan, 8420383
Israel4 sites
Soroka University Medical Center
Beersheba, 8410101
Rabin Medical Center
Petah Tikva, 4941492
The Chaim Sheba Medical Center
Ramat Gan, 5265601
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906
Belgium3 sites
University Hospital Brussels
Brussels, 1090
Cliniques Universitaires Saint-Luc
Brussels, B 1200
University Hospital Antwerp
Edegem, 2650
Finland3 sites
Terveystalo Tampere
Tampere, 33100
Mehiläinen Neo
Turku, 20520
Turun yliopistollinen keskussairaala
Turku, 20520
Romania3 sites
SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
Brasov, JUD. Brasov, 500283
SC Delta Health Care SRL
Bucharest, 014142
Cabinet Medical de Dermatovenerologie Prof. Dr. Orasan Remus Ioan
Cluj-Napoca, JUD. CLUJ, 400105
Serbia3 sites
Military Medical Academy
Belgrade, 11000
Clinical Centre Nis
Niš, 18000
General Hospital Pancevo
Pančevo, 26000
Netherlands1 site
Universitair Medisch Centrum (UMC) Utrecht
Utrecht, 3584 CX
About this study
Official title: A PHASE 3 MULTI-CENTER, LONG-TERM EXTENSION STUDY INVESTIGATING THE EFFICACY AND SAFETY OF ABROCITINIB, WITH OR WITHOUT TOPICAL MEDICATIONS, ADMINISTERED TO SUBJECTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS
B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying parent study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country.
The B7451015 study also includes a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee MRI. The sub-study will be conducted in selected countries at selected sites. Eligible subjects are those who were 12 to <18 years of age at the screening visit of the qualifying parent study and who are currently participating in the main B7451015 study. The sub-study will include serial Magnetic Resonance Imaging (MRI) annually and continue until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued/withdrawn.
- Conditions
- Dermatitis, Atopic
- Being tested
- Abrocitinib 100 mg, Abrocitinib 200 mg, Placebo
- Keywords
- atopic dermatitis, atopic eczema, eczema, JAK, janus kinase, Magnetic Resonance Imaging, MRI
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abrocitinib 100 mgDrug
In the initial treatment period, Abrocitinib 100 mg, administered as two tablets to be taken orally once daily.
Abrocitinib 200 mgDrug
In the initial treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.
PlaceboDrug
For subjects whose dose was changed from 100 mg Abrocitinib to placebo, one tablet will be administered to be taken orally once daily for the remainder of the study.
Abrocitinib 100 mgDrug
For subjects whose dose was changed from 200 mg Abrocitinib to 100 mg PF-04965842, one tablet will be administered to be taken orally once daily for the remainder of the study.
Abrocitinib 100 mgDrug
In the secondary treatment period, Abrocitinib 100 mg, administered as one tablet to be taken orally once daily.
Abrocitinib 200 mgDrug
In the secondary treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Abrocitinib 100 mg | Experimental | Abrocitinib 100 mg QD PO Receives: Drug: Abrocitinib 100 mg; Drug: Placebo |
| Abrocitinib 200 mg | Experimental | Abrocitinib 200 mg QD PO Receives: Drug: Abrocitinib 200 mg; Drug: Abrocitinib 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events
The incidence of treatment emergent adverse events
Measured: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Serious adverse events and adverse events leading to discontinuation
The incidence of serious adverse events and adverse events leading to discontinuation
Measured: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in clinical laboratory values
Change from baseline in clinical laboratory values
Measured: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in electrocardiogram (ECG) measurements
Change from baseline in electrocardiogram (ECG) measurements
Measured: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in vital signs
Change from baseline in vital signs
Measured: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Secondary outcomes (13)
Investigator's Global Assessment (IGA)
Response based on the IGA score of clear (0) or almost clear (1) (on a 5 point scale) and a reduction from baseline of >=2 points at all scheduled time points
Measured: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Eczema Area and Severity Index (EASI)
Response based on greater than or equal to 50%, 75% and 90% improvement from baseline in the EASI total score (EASI50, EASI75, and EASI90) at all scheduled time points
Measured: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Pruritus Numerical Rating Scale (NRS)
Response based on an improvement greater than or equal to 3 points and greater than or equal to 4 points from baseline in the pruritus NRS at all scheduled time points
Measured: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Patient Global Assessment (PtGA)
Change from baseline of PtGA at all scheduled time points
Measured: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Body Surface Area (BSA) affected
Change from baseline in the percentage BSA affected at all scheduled time points
Measured: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI)
Change from baseline in DLQI or CDLQI at all scheduled time points
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Patient Oriented Eczema Measure (POEM)
Change from baseline in POEM at all scheduled time points
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Hospital Anxiety and Depression Scale (HADS)
Change from baseline in HADS at all scheduled time points
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96
EuroQol Quality of Life 5 Dimension 5 Level Scale (EQ-5D-5L) or EuroQol Quality of Life 5 Dimension Youth Scale (EQ-5D-Y)
Change from baseline of EQ-5D-5L or EQ-5D-Y at all scheduled time points
Measured: Baseline, Week 24, Week 48, Week 60, Week 72, Week 92
Steroid-Free Days
Number of steroid-free days will be assessed throughout the duration of the study.
Measured: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Serum Hs-CRP Levels
Serum Hs-CRP levels at all scheduled time points
Measured: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change in height standard deviation score (SDS)
Change in height standard deviation score (SDS) at all scheduled time points
Measured: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Proportion of abnormal findings in knee MRI in adolescent subjects exposed to abrocitinib 100mg and 200mg QD
Proportion of abnormal findings in knee MRI in adolescent subjects exposed to abrocitinib 100mg and 200mg QD
Measured: Throughout sub-study until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued or withdrawn; an estimated maximum of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start8 Mar 2018
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422822
- Sponsor's protocol ID
- B7451015
- Other IDs
- JADE EXTEND, 2023-508955-37-00, 2023
- Acronym
- JADE EXTEND
- Status last verified
- Jan 2026
- First submitted
- 20 Dec 2017
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
- Expanded access
- Available
Publications
Pink AE, Rice ZP, Gooderham MJ, Wang F, Wollenberg A, Biswas P, Chan G, Alderfer J, Watkins M. Does Baseline Severity of Atopic Dermatitis Impact the Long-Term Efficacy of Abrocitinib? Post-hoc Analysis of Two Randomized Trials. Dermatol Ther (Heidelb). 2026 Oct 8. doi: 10.1007/s13555-026-01937-1. Online ahead of print.
PubMed 42844558Weidinger S, Reich K, Issa N, Hong HC, Bunick CG, Biswas P, Chan G, Guler E, Watkins M, Alderfer J. Abrocitinib Achieves Early and Complete/Near-Complete Skin Clearance Plus Itch-Free State in Atopic Dermatitis: Phase 3 Pooled Post Hoc Analysis. Dermatol Ther (Heidelb). 2026 Aug;16(8):4217-4225. doi: 10.1007/s13555-026-01833-8. Epub 2026 Jun 27.
PubMed 42365219Silverberg JI, Simpson EL, Farooqui SA, Chan G, Biswas P, Guler E. Efficacy and Safety of Variable-Dose Versus Continuous-Dose Abrocitinib Treatment in Patients with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis. Dermatol Ther (Heidelb). 2026 May 20. doi: 10.1007/s13555-026-01778-y. Online ahead of print.
PubMed 42162528Paller AS, Eichenfield LF, Irvine AD, Flohr C, Wollenberg A, Barbarot S, Bangert C, Spergel JM, Selfridge A, Biswas P, Fan H, Alderfer J, Watkins M, Koppensteiner H. Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis. Allergy. 2025 Aug;80(8):2213-2224. doi: 10.1111/all.16512. Epub 2025 Mar 3.
PubMed 40028832Silverberg JI, Simpson EL, Pink AE, Weidinger S, Chan G, Biswas P, Clibborn C, Guler E. Switching from Dupilumab to Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of Efficacy After Treatment With Dupilumab in JADE DARE. Dermatol Ther (Heidelb). 2025 Feb;15(2):367-380. doi: 10.1007/s13555-024-01320-y. Epub 2025 Feb 4.
PubMed 39903335Silverberg JI, Thyssen JP, Lazariciu I, Myers DE, Guler E, Chovatiya R. Abrocitinib may improve itch and quality of life in patients with itch-dominant atopic dermatitis. Skin Health Dis. 2024 May 5;4(4):e382. doi: 10.1002/ski2.382. eCollection 2024 Aug.
PubMed 39104653Simpson EL, Silverberg JI, Nosbaum A, Winthrop KL, Guttman-Yassky E, Hoffmeister KM, Egeberg A, Valdez H, Zhang M, Farooqui SA, Romero W, Thorpe AJ, Rojo R, Johnson S. Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Am J Clin Dermatol. 2021 Sep;22(5):693-707. doi: 10.1007/s40257-021-00618-3. Epub 2021 Aug 18.
PubMed 34406619
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 3 MULTI-CENTER, LONG-TERM EXTENSION STUDY INVESTIGATING THE EFFICACY AND SAFETY OF ABROCITINIB, WITH OR WITHOUT TOPICAL MEDICATIONS, ADMINISTERED TO SUBJECTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS
- ClinicalTrials.gov ID
- NCT03422822
- Acronym / sponsor ID
- JADE EXTEND / B7451015
- Conditions
- Dermatitis, Atopic
- Keywords
- atopic dermatitis, atopic eczema, eczema, JAK, janus kinase, Magnetic Resonance Imaging, MRI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,166 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying parent study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country.
The B7451015 study also includes a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee MRI. The sub-study will be conducted in selected countries at selected sites. Eligible subjects are those who were 12 to <18 years of age at the screening visit of the qualifying parent study and who are currently participating in the main B7451015 study. The sub-study will include serial Magnetic Resonance Imaging (MRI) annually and continue until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued/withdrawn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abrocitinib 100 mg | Experimental | Drug: Abrocitinib 100 mg, Drug: PlaceboAbrocitinib 100 mg QD PO |
| Abrocitinib 200 mg | Experimental | Drug: Abrocitinib 200 mg, Drug: Abrocitinib 100 mgAbrocitinib 200 mg QD PO |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.
- Male or female subjects of 12 years of age or older, at the time of informed consent and meets inclusion criterion for minimum body weight (if applicable) from qualifying Parent study. Adolescent subjects below the age of 18 years old (or country-specific age of majority) will only be enrolled in this study if instructed by the sponsor and approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects aged 18 years (or country-specific age of majority) and older will be enrolled.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Must have completed the full treatment period of a qualifying Parent study OR must have completed the full rescue treatment period of a qualifying Parent study (if applicable) OR must have completed the full open-label run-in period in B7451014 and did not meet the protocol-specified response criteria at Week 12.
- Female subjects who are of childbearing potential (which includes all female subjects aged 12 years and older, regardless of whether they have experienced menarche) must ot be intending to become pregnant, currently pregnant, or lactating. The following onditions apply:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abrocitinib 100 mgIn the initial treatment period, Abrocitinib 100 mg, administered as two tablets to be taken orally once daily. | Drug | Abrocitinib 100 mg |
| Abrocitinib 200 mgIn the initial treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily. | Drug | Abrocitinib 200 mg |
| PlaceboFor subjects whose dose was changed from 100 mg Abrocitinib to placebo, one tablet will be administered to be taken orally once daily for the remainder of the study. | Drug | Abrocitinib 100 mg |
| Abrocitinib 100 mgFor subjects whose dose was changed from 200 mg Abrocitinib to 100 mg PF-04965842, one tablet will be administered to be taken orally once daily for the remainder of the study. | Drug | Abrocitinib 200 mg |
| Abrocitinib 100 mgIn the secondary treatment period, Abrocitinib 100 mg, administered as one tablet to be taken orally once daily. | Drug | Abrocitinib 100 mg |
| Abrocitinib 200 mgIn the secondary treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily. | Drug | Abrocitinib 200 mg |
Primary outcome
Treatment emergent adverse events
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
The incidence of treatment emergent adverse events
Serious adverse events and adverse events leading to discontinuation
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
The incidence of serious adverse events and adverse events leading to discontinuation
Change from baseline in clinical laboratory values
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in clinical laboratory values
Change from baseline in electrocardiogram (ECG) measurements
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in electrocardiogram (ECG) measurements
Change from baseline in vital signs
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change from baseline in vital signs
13 secondary outcomes
Investigator's Global Assessment (IGA)
Time frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Eczema Area and Severity Index (EASI)
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Pruritus Numerical Rating Scale (NRS)
Time frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Patient Global Assessment (PtGA)
Time frame: Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Body Surface Area (BSA) affected
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI)
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Patient Oriented Eczema Measure (POEM)
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96
EuroQol Quality of Life 5 Dimension 5 Level Scale (EQ-5D-5L) or EuroQol Quality of Life 5 Dimension Youth Scale (EQ-5D-Y)
Time frame: Baseline, Week 24, Week 48, Week 60, Week 72, Week 92
Steroid-Free Days
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Serum Hs-CRP Levels
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Change in height standard deviation score (SDS)
Time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Proportion of abnormal findings in knee MRI in adolescent subjects exposed to abrocitinib 100mg and 200mg QD
Time frame: Throughout sub-study until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued or withdrawn; an estimated maximum of 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Derived from this study: PubMed 42844558Pink AE, Rice ZP, Gooderham MJ, Wang F, Wollenberg A, Biswas P, Chan G, Alderfer J, Watkins M. Does Baseline Severity of Atopic Dermatitis Impact the Long-Term Efficacy of Abrocitinib? Post-hoc Analysis of Two Randomized Trials. Dermatol Ther (Heidelb). 2026 Oct 8. doi: 10.1007/s13555-026-01937-1. Online ahead of print.
- Derived from this study: PubMed 42365219Weidinger S, Reich K, Issa N, Hong HC, Bunick CG, Biswas P, Chan G, Guler E, Watkins M, Alderfer J. Abrocitinib Achieves Early and Complete/Near-Complete Skin Clearance Plus Itch-Free State in Atopic Dermatitis: Phase 3 Pooled Post Hoc Analysis. Dermatol Ther (Heidelb). 2026 Aug;16(8):4217-4225. doi: 10.1007/s13555-026-01833-8. Epub 2026 Jun 27.
- Derived from this study: PubMed 42162528Silverberg JI, Simpson EL, Farooqui SA, Chan G, Biswas P, Guler E. Efficacy and Safety of Variable-Dose Versus Continuous-Dose Abrocitinib Treatment in Patients with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis. Dermatol Ther (Heidelb). 2026 May 20. doi: 10.1007/s13555-026-01778-y. Online ahead of print.
- Derived from this study: PubMed 40028832Paller AS, Eichenfield LF, Irvine AD, Flohr C, Wollenberg A, Barbarot S, Bangert C, Spergel JM, Selfridge A, Biswas P, Fan H, Alderfer J, Watkins M, Koppensteiner H. Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis. Allergy. 2025 Aug;80(8):2213-2224. doi: 10.1111/all.16512. Epub 2025 Mar 3.
- Derived from this study: PubMed 39903335Silverberg JI, Simpson EL, Pink AE, Weidinger S, Chan G, Biswas P, Clibborn C, Guler E. Switching from Dupilumab to Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of Efficacy After Treatment With Dupilumab in JADE DARE. Dermatol Ther (Heidelb). 2025 Feb;15(2):367-380. doi: 10.1007/s13555-024-01320-y. Epub 2025 Feb 4.
- Derived from this study: PubMed 39104653Silverberg JI, Thyssen JP, Lazariciu I, Myers DE, Guler E, Chovatiya R. Abrocitinib may improve itch and quality of life in patients with itch-dominant atopic dermatitis. Skin Health Dis. 2024 May 5;4(4):e382. doi: 10.1002/ski2.382. eCollection 2024 Aug.
- Derived from this study: PubMed 34406619Simpson EL, Silverberg JI, Nosbaum A, Winthrop KL, Guttman-Yassky E, Hoffmeister KM, Egeberg A, Valdez H, Zhang M, Farooqui SA, Romero W, Thorpe AJ, Rojo R, Johnson S. Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Am J Clin Dermatol. 2021 Sep;22(5):693-707. doi: 10.1007/s40257-021-00618-3. Epub 2021 Aug 18.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
539 sites in 28 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abrocitinib 100 mg and Abrocitinib 200 mg in people with Dermatitis, Atopic, run by Pfizer at 539 sites in 28 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 539 sites in United States, Poland, Canada, Germany, China and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse events (time frame: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422822, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.