Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

NCT ID: NCT04345367

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 727 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-11
• Study Completion Date: 2021-07-13

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Abrocitinib 200 mg plus placebo injection

Abrocitinib 200 mg daily through Week 26, plus placebo injections every other week through Week 24

Group Type: EXPERIMENTAL

Abrocitinib 200 mg

Intervention Type: DRUG

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 plus placebo tablets

Dupilumab 300 mg every other week (2 injections on Day 1) through Week 24, plus placebo tablets daily through Week 26

Group Type: ACTIVE_COMPARATOR

Dupilumab 300 mg

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

Abrocitinib 200 mg

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.

Intervention Type: DRUG

Dupilumab 300 mg

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 18 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Total Skin & Beauty Dermatology Center, PC

Birmingham, Alabama, United States

Clinical Research Center Of Alabama

Birmingham, Alabama, United States

Alliance Dermatology & MOHS Center, PC

Phoenix, Arizona, United States

First OC Dermatology

Fountain Valley, California, United States

Ark Clinical Research

Long Beach, California, United States

Beach Allergy and Asthma Specialty Group, A Medical Corporation

Long Beach, California, United States

Wallace Medical Group, Inc

Los Angeles, California, United States

Empire Clinical Research

Pomona, California, United States

MedDerm Associates

San Diego, California, United States

University of California San Diego Dermatology

San Diego, California, United States

University Clinical Trials Inc.

San Diego, California, United States

Synergy Dermatology

San Francisco, California, United States

Wolverine Clinical Trials, Llc

Santa Ana, California, United States

Clinical Science Institute

Santa Monica, California, United States

Skin Care Research, LLC

Boca Raton, Florida, United States

Olympian Clinical Research

Largo, Florida, United States

Miami Dermatology & Laser Research, LLC

Miami, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Accel Research Sites - Pure Skin Dermatology & Aesthetics

Orlando, Florida, United States

Clinical Research Trials of Florida, Inc.

Tampa, Florida, United States

Olympian Clinical Research

Tampa, Florida, United States

Integrated Clinical Research

West Palm Beach, Florida, United States

One Health Research Clinic

Norcross, Georgia, United States

Sneeze, Wheeze & Itch Associates, LLC

Normal, Illinois, United States

Dundee Dermatology

West Dundee, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

The South Bend Clinic Center for Research

South Bend, Indiana, United States

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, United States

Avant Research Associates, LLC

Crowley, Louisiana, United States

MetroBoston Clinical Partners, LLC

Brighton, Massachusetts, United States

Onyx Clinical Research

Flint, Michigan, United States

Linden Road Imaging Center

Flint, Michigan, United States

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Regional Medical Imaging, P.C. ( Local X-Ray)

Royal Oak, Michigan, United States

Revival Research Institute, LLC

Troy, Michigan, United States

Skin Specialists, PC

Omaha, Nebraska, United States

Vivida Dermatology

Las Vegas, Nevada, United States

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Boice-Willis Clinic, PA

Rocky Mount, North Carolina, United States

Carolina Research Center, Inc.

Shelby, North Carolina, United States

Oregon Medical Research Center

Portland, Oregon, United States

Paddington Testing Co, Inc.

Philadelphia, Pennsylvania, United States

Health Concepts

Rapid City, South Dakota, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

International Clinical Research - Tennessee LLC

Murfreesboro, Tennessee, United States

Center for Clinical Studies, LTD. LLP

Houston, Texas, United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Acclaim Dermatology, PLLC

Sugar Land, Texas, United States

Jordan Valley Dermatology Center

West Jordan, Utah, United States

St George Dermatology and Skin Cancer Centre

Kogarah, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Emeritus Research

Camberwell, Victoria, Australia

Skin Health Institute Inc.

Carlton, Victoria, Australia

Sinclair Dermatology

East Melbourne, Victoria, Australia

Melbourne Health Radiology

Pakrville, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

MHAT Dobrich AD

Dobrich, , Bulgaria

MC Asklepii OOD

Dupnitsa, , Bulgaria

DCC Alexandrovska EOOD

Sofia, , Bulgaria

DCC Fokus-5 - Medical Establishment for Outpatient Care EOOD

Sofia, , Bulgaria

Military Medical Academy MHAT Sofia

Sofia, , Bulgaria

Dermatology Research Institute

Calgary, Alberta, Canada

Alberta DermaSurgery Centre

Edmonton, Alberta, Canada

CARE Clinic Ltd

Red Deer, Alberta, Canada

Dr. Chih-ho Hong Medical Inc

Surrey, British Columbia, Canada

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

Karma Clinical Trials, Inc.

St. John's, Newfoundland and Labrador, Canada

Kingsway Clinical Research

Etobicoke, Ontario, Canada

Medicor Research Inc

Greater Sudbury, Ontario, Canada

Sudbury Skin Clinique

Greater Sudbury, Ontario, Canada

DermEffects

London, Ontario, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

DermEdge Research

Mississauga, Ontario, Canada

North Bay Dermatology Centre

North Bay, Ontario, Canada

The Centre for Clinical Trials

Oakville, Ontario, Canada

Dermatology Ottawa Research Centre

Ottawa, Ontario, Canada

SKiN Centre for Dermatology

Peterborough, Ontario, Canada

The Centre for Dermatology

Richmond Hill, Ontario, Canada

Toronto Research Centre

Toronto, Ontario, Canada

Intermed groupe santé

Chicoutimi, Quebec, Canada

Centre de Recherche Dermatologique du Quebec metropolitain

Québec, Quebec, Canada

Centre de Recherche Saint-Louis

Québec, , Canada

Medicien

Las Condes, Santiago, Santiago Metropolitan, Chile

MIRES (M Y F Estudios Clinicos Limitada)

Nunoa, Santiago, Santiago Metropolitan, Chile

Vida lntegra

Nunoa, Santiago, Santiago Metropolitan, Chile

Centro Radiologico Plaza Baquedano

Santiago, Santiago Metropolitan, Chile

Centro Medico SkinMed Limitada

Santiago, Santiago Metropolitan, Chile

Clínica Dermacross S.A.

Santiago, Santiago Metropolitan, Chile

Hospital Clinico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Centro Internacional de Estudios Clinicos - CIEC

Santiago, Santiago Metropolitan, Chile

Terveystalo Tampere

Tampere, , Finland

Mehiläinen Neo

Turku, , Finland

Turun yliopistollinen keskussairaala

Turku, , Finland

Fachklinik Bad Bentheim

Bad Bentheim, , Germany

Klinikum Bielefeld Rosenhöhe

Bielefeld, , Germany

Klinische Forschung Dresden GmbH

Dresden, , Germany

IKF Pneumologie GmbH & Co KG

Frankfurt am Main, , Germany

SRH Wald-Klinikum Gera GmbH

Gera, , Germany

Studienzentrum Dr. med. Beate Schwarz

Langenau, , Germany

SIBAmed GmbH

Leipzig, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Dermatologische Gemeinschaftspraxis Dres. Quist

Mainz, , Germany

University of Muenster

Münster, , Germany

Clinexpert Kft.

Budapest, , Hungary

Debreceni Egyetem Klinikai Központ

Debrecen, , Hungary

Trial Pharma Kft.

Kaposvár, , Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, , Hungary

Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore

Roma, , Italy

Health Centre 4 Ltd. Diagnostics Centre

Riga, , Latvia

LLC J.Kisis

Riga, , Latvia

Outpatient Clinic of Ventspils

Ventspils, , Latvia

NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.

Bialystok, , Poland

DERMAPOLIS Medical Dermatology Center

Chorzów, , Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

MCBK

Grodzisk Mazowiecki, , Poland

Care Clinic Centrum Medyczne

Katowice, , Poland

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, , Poland

Centrum Medyczne Promed

Krakow, , Poland

Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej "DERMED" Centrum Medyczne

Lodz, , Poland

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, , Poland

Gabinety Lekarskie Rivermed

Poznan, , Poland

Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski, ,,Laser Clinic"

Szczecin, , Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , Poland

Medycyna Kliniczna

Warsaw, , Poland

MTZ Clinical Research Sp. z o.o.

Warsaw, , Poland

Carpe Diem Centrum Medycyny Estetycznej

Warsaw, , Poland

EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej

Wroclaw, , Poland

Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska

Wroclaw, , Poland

Centrum Medyczne Oporow

Wroclaw, , Poland

Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii

Zabrze, , Poland

SUMMIT CLINICAL RESEARCH, s.r.o.

Bratislava, , Slovakia

SKINKLINIK s.r.o

Bratislava, , Slovakia

BeneDerma s.r.o.

Bratislava, , Slovakia

Derma therapy spol. s.r.o.

Bratislava, , Slovakia

Dermatovenerologicka ambulancia

Nové Zámky, , Slovakia

SANARE spol.s.r.o.

Svidník, , Slovakia

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Chonnam National University Hospital

Gwangju, , South Korea

The Catholic University of Korea, Incheon St. Mary's Hospital

Incheon, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Chung-Ang University Hospital

Seoul, , South Korea

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Centro de Especialidades Mollabao (Area Sanitaria de Pontevedra e O Salnes)

Pontevedra, , Spain

Hospital de Montecelo

Pontevedra, , Spain

Taipei Veterans General Hospital

Taipei, Taiwan (r.o.c), Taiwan

Taipei Medical University-Shuang Ho Hospital

New Taipei City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Countries

United States; Australia; Bulgaria; Canada; Chile; Finland; Germany; Hungary; Italy; Latvia; Poland; Slovakia; South Korea; Spain; Taiwan

References

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.

Reference Type: DERIVED

PMID: 40987931 (View on PubMed)

Silverberg 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.

Reference Type: DERIVED

PMID: 39903335 (View on PubMed)

Reich 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.

Reference Type: DERIVED

PMID: 37254941 (View on PubMed)

Reich 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.

Reference Type: DERIVED

PMID: 35871814 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B7451050

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

Other Identifiers

2019-004013-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7451050

Identifier Type: -

Identifier Source: org_study_id