Clinical trial NCT04345367: Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
atopic eczema
eczema
JAK
janus kinase
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-04-14
Enrollment: 727
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Week 2
measure: Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Percentage of Participants Achieving EASI-90 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26
timeFrame: Week 2, 8, 12, 20 and 26
measure: Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26
timeFrame: Week 2, 4, 8, 12, 16, 20 and 26
measure: 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
timeFrame: Week 2, 4, 8, 12, 16, 20 and 26
measure: Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15
timeFrame: Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
measure: Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26
timeFrame: Week 4, 8, 12, 16, 20 and 26
measure: Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4)
timeFrame: Baseline (Day 1) up to Week 30
measure: Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26
timeFrame: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26
measure: Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26
timeFrame: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26
measure: Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26
timeFrame: Baseline (Day 1), Week 12, 16 and 26
measure: Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26
timeFrame: Baseline (Day 1), Week 12, 16 and 26
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26
timeFrame: Baseline (Day 1), Week 2, 12, 16, 20 and 26
measure: Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26
timeFrame: Baseline (Day 1), Week 12, 16 and 26
measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26
timeFrame: Baseline (Day 1), Week 12, 16 and 26
measure: Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26
timeFrame: Baseline (Day 1), Week 12, 16 and 26
measure: Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26
timeFrame: Baseline (Day 1), Week 2, 12, 16, 20 and 26
measure: Medicated Topical Background Therapy-free Days
timeFrame: Day 1 up to Week 26
measure: Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26
timeFrame: Week 2, 12, 16, 20 and 26
Other outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs)
timeFrame: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
measure: Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation
timeFrame: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
measure: Number of Participants With Laboratory Abnormalities Meeting Pre-Defined Criteria
timeFrame: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
measure: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Data
timeFrame: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center, PC
state: Alabama
city: Birmingham
country: United States
facility: Clinical Research Center Of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Alliance Dermatology & MOHS Center, PC
state: Arizona
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Long Beach
country: United States
facility: Beach Allergy and Asthma Specialty Group, A Medical Corporation
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group, Inc
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: San Diego
country: United States
facility: MedDerm Associates
state: California
city: San Diego
country: United States
facility: University of California San Diego Dermatology
state: California
city: San Diego
country: United States
facility: University Clinical Trials Inc.
state: California
city: San Francisco
country: United States
facility: Synergy Dermatology
state: California
city: Santa Ana
country: United States
facility: Wolverine Clinical Trials, Llc
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Boca Raton
country: United States
facility: Skin Care Research, LLC
state: Florida
city: Largo
country: United States
facility: Olympian Clinical Research
state: Florida
city: Miami
country: United States
facility: Miami Dermatology & Laser Research, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Accel Research Sites - Pure Skin Dermatology & Aesthetics
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Integrated Clinical Research
state: Florida
city: Norcross
country: United States
facility: One Health Research Clinic
state: Georgia
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates, LLC
state: Illinois
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic Center for Research
state: Indiana
city: Overland Park
country: United States
facility: Epiphany Dermatology of Kansas, LLC
state: Kansas
city: Crowley
country: United States
facility: Avant Research Associates, LLC
state: Louisiana
city: Brighton
country: United States
facility: MetroBoston Clinical Partners, LLC
state: Massachusetts
city: Flint
country: United States
facility: Onyx Clinical Research
state: Michigan
city: Flint
country: United States
facility: Linden Road Imaging Center
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Royal Oak
country: United States
facility: Regional Medical Imaging, P.C. ( Local X-Ray)
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Las Vegas
country: United States
facility: Vivida Dermatology
state: Nevada
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Rocky Mount
country: United States
facility: Boice-Willis Clinic, PA
state: North Carolina
city: Shelby
country: United States
facility: Carolina Research Center, Inc.
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Co, Inc.
state: Pennsylvania
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC
state: Tennessee
city: Houston
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Acclaim Dermatology, PLLC
state: Texas
city: West Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Kogarah
country: Australia
facility: St George Dermatology and Skin Cancer Centre
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Carlton
country: Australia
facility: Skin Health Institute Inc.
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Pakrville
country: Australia
facility: Melbourne Health Radiology
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Dobrich
country: Bulgaria
facility: MHAT Dobrich AD
city: Dupnitsa
country: Bulgaria
facility: MC Asklepii OOD
city: Sofia
country: Bulgaria
facility: DCC Alexandrovska EOOD
city: Sofia
country: Bulgaria
facility: DCC Fokus-5 - Medical Establishment for Outpatient Care EOOD
city: Sofia
country: Bulgaria
facility: Military Medical Academy MHAT Sofia
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre
state: Alberta
city: Red Deer
country: Canada
facility: CARE Clinic Ltd
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: St. John's
country: Canada
facility: Karma Clinical Trials, Inc.
state: Newfoundland and Labrador
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials
state: Ontario
city: Ottawa
country: Canada
facility: Dermatology Ottawa Research Centre
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury Skin Clinique
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Chicoutimi
country: Canada
facility: Intermed groupe santé
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Las Condes, Santiago
country: Chile
facility: Medicien
state: Region Metropolitana
city: Nunoa, Santiago
country: Chile
facility: MIRES (M Y F Estudios Clinicos Limitada)
state: Region Metropolitana
city: Nunoa, Santiago
country: Chile
facility: Vida lntegra
state: Region Metropolitana
city: Santiago
country: Chile
facility: Centro Radiologico Plaza Baquedano
state: Region Metropolitana
city: Santiago
country: Chile
facility: Centro Medico SkinMed Limitada
state: Region Metropolitana
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile
state: Region Metropolitana
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos - CIEC
state: Region Metropolitana
city: Santiago
country: Chile
facility: Clínica Dermacross S.A.
state: Región Metropolitana
city: Tampere
country: Finland
facility: Terveystalo Tampere
city: Turku
country: Finland
facility: Mehiläinen Neo
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld Rosenhöhe
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Frankfurt am Main
country: Germany
facility: IKF Pneumologie GmbH & Co KG
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
city: Langenau
country: Germany
facility: Studienzentrum Dr. med. Beate Schwarz
city: Leipzig
country: Germany
facility: SIBAmed GmbH
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Mainz
country: Germany
facility: Dermatologische Gemeinschaftspraxis Dres. Quist
city: Muenster
country: Germany
facility: University of Muenster
city: Budapest
country: Hungary
facility: Clinexpert Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
city: Kaposvár
country: Hungary
facility: Trial Pharma Kft.
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Riga
country: Latvia
facility: Health Centre 4 Ltd. Diagnostics Centre
city: Riga
country: Latvia
facility: LLC J.Kisis
city: Ventspils
country: Latvia
facility: Outpatient Clinic of Ventspils
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.
city: Chorzow
country: Poland
facility: DERMAPOLIS Medical Dermatology Center
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Grodzisk Mazowiecki
country: Poland
facility: MCBK
city: Katowice
country: Poland
facility: Care Clinic Centrum Medyczne
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o.
city: Krakow
country: Poland
facility: Centrum Medyczne Promed
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
city: Lodz
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "DERMED" Centrum Medyczne
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Poznan
country: Poland
facility: Gabinety Lekarskie Rivermed
city: Szczecin
country: Poland
facility: Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski, ,,Laser Clinic"
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: Medycyna Kliniczna
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
city: Warszawa
country: Poland
facility: Carpe Diem Centrum Medycyny Estetycznej
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
city: Wroclaw
country: Poland
facility: Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Zabrze
country: Poland
facility: Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii
city: Bratislava
country: Slovakia
facility: SUMMIT CLINICAL RESEARCH, s.r.o.
city: Bratislava
country: Slovakia
facility: SKINKLINIK s.r.o
city: Bratislava
country: Slovakia
facility: BeneDerma s.r.o.
city: Bratislava
country: Slovakia
facility: Derma therapy spol. s.r.o.
city: Nove Zamky
country: Slovakia
facility: Dermatovenerologicka ambulancia
city: Svidnik
country: Slovakia
facility: SANARE spol.s.r.o.
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pontevedra
country: Spain
facility: Centro de Especialidades Mollabao (Area Sanitaria de Pontevedra e O Salnes)
city: Pontevedra
country: Spain
facility: Hospital de Montecelo
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
state: Taiwan (r.o.c)
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.