Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
NCT ID: NCT03575871
Last Updated: 2020-04-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
391 participants
INTERVENTIONAL
2018-06-29
2019-08-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
NCT03349060
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
NCT03627767
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
NCT03720470
Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis
NCT03915496
Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis
NCT02780167
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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 severity 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
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emmaus Research Center, Inc.
Anaheim, California, United States
Advanced Research Center, Inc. - Los Alamitos Site
Los Alamitos, California, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, United States
Clinical Science Institute
Santa Monica, California, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States
Colorado Springs Dermatology Clinic, PC
Colorado Springs, Colorado, United States
Olympian Clinical Research
Clearwater, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Precision Imaging
Jacksonville, Florida, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Imaging Center of Idaho
Caldwell, Idaho, United States
ASR, LLC
Nampa, Idaho, United States
Meridian Clinical Research
Baton Rouge, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Sadick Research Group
New York, New York, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
The Ohio State University Dermatology East
Gahanna, Ohio, United States
Tanenbaum Dermatology Center
Memphis, Tennessee, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Austin Institute for Clinical Research, Inc. - Central
Austin, Texas, United States
Center for Clinical Studies, LTD. LLP
Houston, Texas, United States
West Houston Dermatology, PA
Houston, Texas, United States
Summit Clinical Research, LLC
Franklin, Virginia, United States
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, United States
Australian Clinical Research Network
Maroubra, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
Skin and Cancer Foundation Inc
Carlton, VIC 3053, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
The Royal Children's Hospital (RCH)
Parkville, Victoria, Australia
Medical Centre Asklepii OOD
Dupnitsa, , Bulgaria
MHAT Dr. Tota Venkova AD
Gabrovo, , Bulgaria
"Acibadem City Clinic MHAT Tokuda" EAD
Sofia, , Bulgaria
"DCC Aleksandrovska" EOOD
Sofia, , Bulgaria
Diagnostic Consultative Center Fokus-5
Sofia, , Bulgaria
Medical Centre Synexus Sofia EOOD
Sofia, , Bulgaria
University of British Columbia Department of Dermatology and Skin Science
Vancouver, British Columbia, Canada
Winnipeg Clinic
Winnipeg, Manitoba, Canada
North York Research Inc.
North York, Ontario, Canada
Oshawa Clinic Dermatology Trials
Oshawa, Ontario, Canada
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Army Medical University, PLA
Chongqing, Chongqing Municipality, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China
Tianjin Medical University General Hospital, Dermatological Department
Tianjin, , China
Dermamedica S.R.O.
Náchod, , Czechia
Oblastni nemocnice Nachod a.s., Radiodiagnosticke oddeleni
Náchod, , Czechia
Lekarna u Stribrneho orla
Náchod, , Czechia
Sanatorium profesora Arenbergera
Prague, , Czechia
Lekarna U sv. Ignace
Prague, , Czechia
Dermatologicka Ambulance
Svitavy, , Czechia
Lekarna na Hranicni
Svitavy, , Czechia
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
ISA GmbH
Berlin, , Germany
Fachärztliche Gemeinschaftspraxis für Dermatologie und Venerologie, Allergologie,
Blankenfelde-Mahlow, , Germany
IKF Pneumologie GmbH & Co KG
Frankfurt, , Germany
Klinische Forschung Hamburg GmbH
Hamburg, , Germany
Universitaet Muenster
Münster, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
SE AOK Bor, Nemikortani es Boronkologiai Klinika
Budapest, , Hungary
Budapest Főváros XIX. Kerületi Önkormányzat Kispesti Egészsegügyi Intézete
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
ALLERGO-DERM BAKOS Kft.
Szolnok, , Hungary
Queen's square Medical Facilities Queen's square Dermatology and Allergology
Yokohama, Kanagawa, Japan
Noguchi Dermatology Clinic
Kamimashiki-gun, Kumamoto, Japan
Yoshioka Dermatology Clinic
Neyagawa, Osaka, Japan
Kume Clinic
Sakai, Osaka, Japan
Sumire Dermatology Clinic
Edogawa-ku, Tokyo, Japan
Matsuyama Dermatology Clinic
Nakano-ku, Tokyo, Japan
Hoshikuma Dermatology・Allergy Clinic
Fukuoka, , Japan
Sanrui Hifuka
Saitama, , Japan
Selga Freiberga private practice in dermatovenerology and cosmetology
Jelgava, , Latvia
Riga 1st Hospital, Clinic for Dermatology and STD
Riga, , Latvia
Aesthetic dermatology clinic of Prof. J. Kisis
Riga, , Latvia
Health Centre 4 Ltd. Diagnostics Centre
Riga, , Latvia
Health Centre 4 Ltd
Riga, , Latvia
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.
Bialystok, , Poland
KLIMED Marek Klimkiewicz
Bialystok, , Poland
Centrum Badań Klinicznych JCI
Krakow, , Poland
Centrum Nowoczesnych Terapii "DOBRY LEKARZ" sp. z o. o.
Krakow, , Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, , Poland
KO-MED Centra Kliniczne Lublin II
Lublin, , Poland
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
Poznan, , Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, , Poland
Synexus Polska Sp. z o. o. Oddzial w Warszawie
Warsaw, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, , Poland
Klinika Ambroziak Sp. z o.o.
Warsaw, , Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, , Poland
Lukasz Matusiak "4HEALTH"
Wroclaw, , Poland
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
The Catholic University of Korea, Incheon St.Mary's Hospital
Bupyeong-gu, Incheon, South Korea
Inha University Hospital
Jung-gu, Incheon, South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital, Yonsei Univ. Health System
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Hallym university Kangnam Sacred Heart Hospital
Seoul, , South Korea
Plymouth Hospitals NHS Trust, Derriford Hospital
Plymouth, Devon, United Kingdom
MAC Clinical Research
Blackpool, Lancashire, United Kingdom
MAC Clinical Research Ltd
Cannock, South Staffordshire, United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, United Kingdom
University Hospital Bristol NHS Foundation Trust
Bristol, , United Kingdom
MAC Clinical Research Ltd
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Yosipovitch G, Gooderham MJ, Stander S, Fonacier L, Szepietowski JC, Deleuran M, Girolomoni G, Su JC, Bushmakin AG, Cappelleri JC, Feeney C, Chan G, Thorpe AJ, Valdez H, Biswas P, Rojo R, DiBonaventura M, Myers DE. Interpreting the Relationship Among Itch, Sleep, and Work Productivity in Patients with Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of JADE MONO-2. Am J Clin Dermatol. 2024 Jan;25(1):127-138. doi: 10.1007/s40257-023-00810-7. Epub 2023 Aug 25.
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.
Silverberg JI, Simpson EL, Thyssen JP, Gooderham M, Chan G, Feeney C, Biswas P, Valdez H, DiBonaventura M, Nduaka C, Rojo R. Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2020 Aug 1;156(8):863-873. doi: 10.1001/jamadermatol.2020.1406.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MONO-2
Identifier Type: OTHER
Identifier Source: secondary_id
2018-001136-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7451013
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.