Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS
2 other identifiers
interventional
727
15 countries
151
Brief Summary
This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2020
Shorter than P25 for phase_3
151 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2020
CompletedFirst Posted
Study publicly available on registry
April 14, 2020
CompletedStudy Start
First participant enrolled
June 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2021
CompletedResults Posted
Study results publicly available
July 8, 2022
CompletedJuly 8, 2022
June 1, 2022
1.1 years
March 27, 2020
June 9, 2022
June 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2
The severity of itch (pruritus) due to atopic dermatitis (AD) was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Week 2
Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4
EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.
Week 4
Secondary Outcomes (18)
Percentage of Participants Achieving EASI-90 Response at Week 16
Week 16
Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26
Week 2, 8, 12, 20 and 26
Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26
Week 2, 4, 8, 12, 16, 20 and 26
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26
Week 2, 4, 8, 12, 16, 20 and 26
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15
Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
- +13 more secondary outcomes
Other Outcomes (5)
Number of Participants With Treatment Emergent Adverse Events (AEs)
From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation
From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Number of Participants With Laboratory Abnormalities Meeting Pre-Defined Criteria
From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
- +2 more other outcomes
Study Arms (2)
Abrocitinib 200 mg plus placebo injection
EXPERIMENTALAbrocitinib 200 mg daily through Week 26, plus placebo injections every other week through Week 24
Dupilumab 300 mg plus placebo tablets
ACTIVE COMPARATORDupilumab 300 mg every other week (2 injections on Day 1) through Week 24, plus placebo tablets daily through Week 26
Interventions
Abrocitinib 200 mg administered as two 100 mg tablets to be taken orally once daily for 26 weeks. Placebo injections will be administered every other week for 24 weeks.
Dupilumab 300 mg administered as a single subcutaneous injection every other week for 24 weeks (2 injections on day 1). Placebo tablets will be administered daily.
Eligibility Criteria
You may qualify if:
- years of age or older
- Diagnosis of chronic atopic dermatitis (AD) for at least 6 months
- Moderate to severe AD (BSA at least 10%, IGA at least 3, EASI at least 16, and PP-NRS severity score at least 4)
- Recent history of inadequate response to treatment with medicated topical therapy for AD, or who have required systemic therapies for control of their disease
You may not qualify if:
- Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
- Have increased risk of developing venous thromboembolism
- Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
- Prior treatment with systemic JAK inhibitors or IL-4 or IL-13 antagonists including dupilumab, lebrikizumab or tralokinumab
- Other active non-AD inflammatory skin diseases or conditions affecting skin
- 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
- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (151)
Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama, 35205, United States
Clinical Research Center Of Alabama
Birmingham, Alabama, 35209, United States
Alliance Dermatology & MOHS Center, PC
Phoenix, Arizona, 85032, United States
First OC Dermatology
Fountain Valley, California, 92708, United States
Ark Clinical Research
Long Beach, California, 90806, United States
Beach Allergy and Asthma Specialty Group, A Medical Corporation
Long Beach, California, 90808, United States
Wallace Medical Group, Inc
Los Angeles, California, 90056, United States
Empire Clinical Research
Pomona, California, 91767, United States
MedDerm Associates
San Diego, California, 92103, United States
University of California San Diego Dermatology
San Diego, California, 92122, United States
University Clinical Trials Inc.
San Diego, California, 92123, United States
Synergy Dermatology
San Francisco, California, 94132, United States
Wolverine Clinical Trials, Llc
Santa Ana, California, 92705, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Skin Care Research, LLC
Boca Raton, Florida, 33486, United States
Olympian Clinical Research
Largo, Florida, 33770, United States
Miami Dermatology & Laser Research, LLC
Miami, Florida, 33173, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Accel Research Sites - Pure Skin Dermatology & Aesthetics
Orlando, Florida, 32819, United States
Clinical Research Trials of Florida, Inc.
Tampa, Florida, 33607, United States
Olympian Clinical Research
Tampa, Florida, 33614, United States
Integrated Clinical Research
West Palm Beach, Florida, 33406, United States
One Health Research Clinic
Norcross, Georgia, 30093, United States
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, 61761, United States
Dundee Dermatology
West Dundee, Illinois, 60118, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
The South Bend Clinic Center for Research
South Bend, Indiana, 46617, United States
Epiphany Dermatology of Kansas, LLC
Overland Park, Kansas, 66215, United States
Avant Research Associates, LLC
Crowley, Louisiana, 70526, United States
MetroBoston Clinical Partners, LLC
Brighton, Massachusetts, 02135, United States
Onyx Clinical Research
Flint, Michigan, 48507, United States
Linden Road Imaging Center
Flint, Michigan, 48532, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Regional Medical Imaging, P.C. ( Local X-Ray)
Royal Oak, Michigan, 48067, United States
Revival Research Institute, LLC
Troy, Michigan, 48084, United States
Skin Specialists, PC
Omaha, Nebraska, 68144, United States
Vivida Dermatology
Las Vegas, Nevada, 89148, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Boice-Willis Clinic, PA
Rocky Mount, North Carolina, 27804, United States
Carolina Research Center, Inc.
Shelby, North Carolina, 28150, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Paddington Testing Co, Inc.
Philadelphia, Pennsylvania, 19103, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130, United States
Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
Acclaim Dermatology, PLLC
Sugar Land, Texas, 77479, United States
Jordan Valley Dermatology Center
West Jordan, Utah, 84088, United States
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, 2217, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
Skin Health Institute Inc.
Carlton, Victoria, 3053, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
Melbourne Health Radiology
Pakrville, Victoria, 3050, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
MHAT Dobrich AD
Dobrich, 9300, Bulgaria
MC Asklepii OOD
Dupnitsa, 2600, Bulgaria
DCC Alexandrovska EOOD
Sofia, 1431, Bulgaria
DCC Fokus-5 - Medical Establishment for Outpatient Care EOOD
Sofia, 1463, Bulgaria
Military Medical Academy MHAT Sofia
Sofia, 1606, Bulgaria
Dermatology Research Institute
Calgary, Alberta, T2J7E1, Canada
Alberta DermaSurgery Centre
Edmonton, Alberta, T6G1C3, Canada
CARE Clinic Ltd
Red Deer, Alberta, T4P-1K4, Canada
Dr. Chih-ho Hong Medical Inc
Surrey, British Columbia, V3R 6A7, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
Karma Clinical Trials, Inc.
St. John's, Newfoundland and Labrador, A1A 4Y3, Canada
Kingsway Clinical Research
Etobicoke, Ontario, M8X 1Y9, Canada
Medicor Research Inc
Greater Sudbury, Ontario, P3A 1W8, Canada
Sudbury Skin Clinique
Greater Sudbury, Ontario, P3C 1X8, Canada
DermEffects
London, Ontario, N6H 5L5, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X2, Canada
DermEdge Research
Mississauga, Ontario, L5H 1G9, Canada
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7, Canada
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5, Canada
Dermatology Ottawa Research Centre
Ottawa, Ontario, K2C 3N2, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5, Canada
Toronto Research Centre
Toronto, Ontario, M3H5Y8, Canada
Intermed groupe santé
Chicoutimi, Quebec, G7H 7Y8, Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, Quebec, G1V 4x7, Canada
Centre de Recherche Saint-Louis
Québec, G1W4R4, Canada
Medicien
Las Condes, Santiago, Santiago Metropolitan, 7580150, Chile
MIRES (M Y F Estudios Clinicos Limitada)
Nunoa, Santiago, Santiago Metropolitan, 7750495, Chile
Vida lntegra
Nunoa, Santiago, Santiago Metropolitan, 7750495, Chile
Centro Radiologico Plaza Baquedano
Santiago, Santiago Metropolitan, 7500906, Chile
Centro Medico SkinMed Limitada
Santiago, Santiago Metropolitan, 7580206, Chile
Clínica Dermacross S.A.
Santiago, Santiago Metropolitan, 7640881, Chile
Hospital Clinico Universidad de Chile
Santiago, Santiago Metropolitan, 8380456, Chile
Centro Internacional de Estudios Clinicos - CIEC
Santiago, Santiago Metropolitan, 8420383, Chile
Terveystalo Tampere
Tampere, 33100, Finland
Mehiläinen Neo
Turku, 20520, Finland
Turun yliopistollinen keskussairaala
Turku, 20520, Finland
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
Klinikum Bielefeld Rosenhöhe
Bielefeld, 33647, Germany
Klinische Forschung Dresden GmbH
Dresden, 01069, Germany
IKF Pneumologie GmbH & Co KG
Frankfurt am Main, 60596, Germany
SRH Wald-Klinikum Gera GmbH
Gera, 07548, Germany
Studienzentrum Dr. med. Beate Schwarz
Langenau, 89129, Germany
SIBAmed GmbH
Leipzig, 04103, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538, Germany
Dermatologische Gemeinschaftspraxis Dres. Quist
Mainz, 55128, Germany
University of Muenster
Münster, 48149, Germany
Clinexpert Kft.
Budapest, 1033, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, 4032, Hungary
Trial Pharma Kft.
Kaposvár, 7400, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, 6720, Hungary
Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore
Roma, 00168, Italy
Health Centre 4 Ltd. Diagnostics Centre
Riga, LV-1003, Latvia
LLC J.Kisis
Riga, LV-1003, Latvia
Outpatient Clinic of Ventspils
Ventspils, LV-3601, Latvia
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.
Bialystok, 15-453, Poland
DERMAPOLIS Medical Dermatology Center
Chorzów, 41-500, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
MCBK
Grodzisk Mazowiecki, 05-825, Poland
Care Clinic Centrum Medyczne
Katowice, 40-568, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, 31-501, Poland
Centrum Medyczne Promed
Krakow, 31-513, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, 90-242, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "DERMED" Centrum Medyczne
Lodz, 90-265, Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, 27-400, Poland
Gabinety Lekarskie Rivermed
Poznan, 61-441, Poland
Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski, ,,Laser Clinic"
Szczecin, 70-332, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
Medycyna Kliniczna
Warsaw, 00-874, Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106, Poland
Carpe Diem Centrum Medycyny Estetycznej
Warsaw, 02-661, Poland
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
Wroclaw, 50-220, Poland
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
Wroclaw, 50-566, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii
Zabrze, 41-800, Poland
SUMMIT CLINICAL RESEARCH, s.r.o.
Bratislava, 831 01, Slovakia
SKINKLINIK s.r.o
Bratislava, 83103, Slovakia
BeneDerma s.r.o.
Bratislava, 841 02, Slovakia
Derma therapy spol. s.r.o.
Bratislava, 851 01, Slovakia
Dermatovenerologicka ambulancia
Nové Zámky, 940 34, Slovakia
SANARE spol.s.r.o.
Svidník, 089 01, Slovakia
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 21431, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Centro de Especialidades Mollabao (Area Sanitaria de Pontevedra e O Salnes)
Pontevedra, 36001, Spain
Hospital de Montecelo
Pontevedra, 36071, Spain
Taipei Veterans General Hospital
Taipei, Taiwan (r.o.c), 11217, Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 23561, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (4)
Simpson EL, Silverberg JI, Geng B, Carrascosa JM, Bieber T, Brunner PM, Staumont-Salle D, Ji C, Biswas P, Feeney C, Hernandez-Martin I, Rebollo Laserna FJ, Koppensteiner H. Do Allergic Comorbidities Alter the Efficacy and Safety of Abrocitinib or Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis? Dermatol Ther (Heidelb). 2025 Nov;15(11):3391-3407. doi: 10.1007/s13555-025-01516-w. Epub 2025 Sep 23.
PMID: 40987931DERIVEDSilverberg 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.
PMID: 39903335DERIVEDReich K, Thyssen JP, Blauvelt A, Eyerich K, Soong W, Rice ZP, Hong HC, Katoh N, Valenzuela F, DiBonaventura M, Bratt TA, Zhang F, Clibborn C, Rojo R, Valdez H, Kerkmann U. Comparing how well abrocitinib and dupilumab treat atopic dermatitis signs and symptoms: a plain language summary. Immunotherapy. 2023 Sep;15(13):975-980. doi: 10.2217/imt-2022-0306. Epub 2023 May 31.
PMID: 37254941DERIVEDReich K, Thyssen JP, Blauvelt A, Eyerich K, Soong W, Rice ZP, Hong HC, Katoh N, Valenzuela F, DiBonaventura M, Bratt TA, Zhang F, Clibborn C, Rojo R, Valdez H, Kerkmann U. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial. Lancet. 2022 Jul 23;400(10348):273-282. doi: 10.1016/S0140-6736(22)01199-0.
PMID: 35871814DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2020
First Posted
April 14, 2020
Study Start
June 11, 2020
Primary Completion
July 13, 2021
Study Completion
July 13, 2021
Last Updated
July 8, 2022
Results First Posted
July 8, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
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.