Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
NCT ID: NCT03349060
Last Updated: 2019-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
387 participants
INTERVENTIONAL
2017-12-07
2019-03-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PF-04965842 100 mg
PF-04965842 100 mg
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks
PF-04965842 200 mg
PF-04965842 200 mg
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks
Placebo
Placebo
Placebo, administered as two tablets to be taken orally once daily for 12 weeks
Interventions
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PF-04965842 100 mg
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks
PF-04965842 200 mg
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks
Placebo
Placebo, administered as two tablets to be taken orally once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (\>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS 4)
* Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control
Exclusion Criteria
* Prior treatment with JAK inhibitors
* Other active nonAD inflammatory skin diseases or conditions affecting skin
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, 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
12 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Rady Children's Hospital - San Diego/University of California, San Diego
San Diego, California, United States
TCR Medical Corporation
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, United States
Olympian Clinical Research
Largo, Florida, United States
Forward Clinical Trials, Inc.
Tampa, Florida, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Henry Ford Medical Center, New Center One
Detroit, Michigan, United States
Somerset Skin Centre
Troy, Michigan, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Medical University of South Carolina Investigational Drug Services
Charleston, South Carolina, United States
MUSC SCTR Research Nexus Clinic and Laboratory
Charleston, South Carolina, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
The University of Texas Health Science Center Houston
Houston, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Pace Dermatology Associates
Lakewood, Washington, United States
MultiCare Allenmore Hospital
Tacoma, Washington, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States
Pace Dermatology Associates
Tacoma, Washington, United States
Australian Clinical Research Network (ACRN)
Maroubra, New South Wales, Australia
Spectrum Medical Imaging
Maroubra, New South Wales, Australia
Queensland X-Ray
Upper Mount Gravatt, Queensland, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
Emeritus Research
Camberwell, Victoria, Australia
Skin and Cancer Foundation Inc
Carlton, Victoria, Australia
Melbourne Radiology Clinic
East Melbourne, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
The Royal Children's Hospital
Parkville, Victoria, Australia
Bridge Road Imaging
Richmond, Victoria, Australia
Kirk Barber Research
Calgary, Alberta, Canada
Institute for Skin Advancement
Calgary, Alberta, Canada
Dr. Chih-ho Hong Medical Inc
Surrey, British Columbia, Canada
University of British Columbia Department of Dermatology and Skin Science
Vancouver, British Columbia, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
Lynderm Research Inc
Markham, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
York Dermatology Center
Richmond Hill, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Lekarna Na Vaclavskem namesti
Kutná Hora, , Czechia
Kozni ambulance Kutna Hora, s.r.o.
Kutná Hora, , Czechia
Lekarna Fakultni Nemocnice Ostrava
Ostrava - Poruba, , Czechia
Fakultni Nemocnice Ostrava, Kozni oddeleni
Ostrava - Poruba, , Czechia
Sanatorium profesora Arenbergera
Prague, , Czechia
Lekarna U sv. Ignace
Prague, , Czechia
Krajska zdravotni a.s.,Masarykova nemocnice o.z.
Ústí nad Labem, , Czechia
Lekarna Masarykovy nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, , Czechia
Universitaetsklinikum Schleswig-Holstein/Campus Luebeck
Lübeck, Schleswig-Holstein, Germany
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Charité - Universitaetsmedizin Berlin, CCM
Berlin, , Germany
ISA - Interdisciplinary Study Association GmbH
Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
Dresden, , Germany
Universitätsklinikum Erlangen, Hautklinik
Erlangen, , Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Ludwig-Maximilians-University Munich
Munich, , Germany
Universitätsklinikum Münster
Münster, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Bács-Kiskun Megyei Kórház, Bőr-és nemibeteg Szakrendelés
Kecskemét, Bács-Kiskun county, Hungary
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
Debrecen, , Hungary
Bacs-Kiskun Megyei Korhaz Kozponti Radiologiai Osztaly
Kecskemét, , Hungary
CRU Hungary Ltd.
Miskolc, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-,Nemikortani es Onkodermatologiai Klinika
Pécs, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
MULTIKLINIKA Salute Sp. z o.o.
Katowice, , Poland
Silmedic Sp. z o.o., Oddzial w Katowicach
Katowice, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
Pro Familia Altera Sp. z o.o.
Katowice, , Poland
NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi
Lodz, , Poland
Dermoklinika Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak
Lodz, , Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, , Poland
Wojskowy Instytut Medyczny, Klinika Dermatologiczna
Warsaw, , Poland
Derriford Hospital, Plymouth Hospitals NHS Trust
Plymouth, Devon, United Kingdom
Royal Free London NHS Foundation Trust
London, Greater London, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, England, United Kingdom
Sheffield Children's Hospital NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, , United Kingdom
Countries
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References
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Paller 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.
Silverberg 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.
Armstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19.
Schmid-Grendelmeier P, Gooderham MJ, Hartmann K, Konstantinou GN, Fellmann M, Koulias C, Clibborn C, Biswas P, Brunner PM. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies. Allergy. 2024 Jan;79(1):174-183. doi: 10.1111/all.15952. Epub 2023 Nov 21.
Alexis AF, Silverberg JI, Rice ZP, Armstrong AW, Desai SR, Fonacier L, Kabashima K, Biswas P, Cella RR, Chan GL, Levenberg M. Abrocitinib efficacy and safety in moderate-to-severe atopic dermatitis by race, ethnicity, and Fitzpatrick skin type. Ann Allergy Asthma Immunol. 2024 Mar;132(3):383-389.e3. doi: 10.1016/j.anai.2023.11.002. Epub 2023 Nov 10.
Blauvelt A, Boguniewicz M, Brunner PM, Luna PC, Biswas P, DiBonaventura M, Farooqui SA, Rojo R, Cameron MC. Abrocitinib monotherapy in Investigator's Global Assessment nonresponders: improvement in signs and symptoms of atopic dermatitis and quality of life. J Dermatolog Treat. 2022 Aug;33(5):2605-2613. doi: 10.1080/09546634.2022.2059053. Epub 2022 Jul 6.
Stander S, Bhatia N, Gooderham MJ, Silverberg JI, Thyssen JP, Biswas P, DiBonaventura M, Romero W, Farooqui SA. High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. J Eur Acad Dermatol Venereol. 2022 Aug;36(8):1308-1317. doi: 10.1111/jdv.18170. Epub 2022 May 6.
Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib. Br J Clin Pharmacol. 2022 Aug;88(8):3856-3871. doi: 10.1111/bcp.15334. Epub 2022 Apr 11.
Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.
Cork MJ, McMichael A, Teng J, Valdez H, Rojo R, Chan G, Zhang F, Myers DE, DiBonaventura M. Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes. J Eur Acad Dermatol Venereol. 2022 Mar;36(3):422-433. doi: 10.1111/jdv.17792. Epub 2021 Dec 4.
Simpson 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.
Silverberg JI, Thyssen JP, Simpson EL, Yosipovitch G, Stander S, Valdez H, Rojo R, Biswas P, Myers DE, Feeney C, DiBonaventura M. Impact of Oral Abrocitinib Monotherapy on Patient-Reported Symptoms and Quality of Life in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis of Patient-Reported Outcomes. Am J Clin Dermatol. 2021 Jul;22(4):541-554. doi: 10.1007/s40257-021-00604-9. Epub 2021 May 5.
Simpson EL, Sinclair R, Forman S, Wollenberg A, Aschoff R, Cork M, Bieber T, Thyssen JP, Yosipovitch G, Flohr C, Magnolo N, Maari C, Feeney C, Biswas P, Tatulych S, Valdez H, Rojo R. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020 Jul 25;396(10246):255-266. doi: 10.1016/S0140-6736(20)30732-7.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2017-003651-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MONO-1
Identifier Type: OTHER
Identifier Source: secondary_id
JADE MONO-1
Identifier Type: OTHER
Identifier Source: secondary_id
B7451012
Identifier Type: -
Identifier Source: org_study_id