JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis
JADE TEEN
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 CO-ADMINISTERED WITH BACKGROUND MEDICATED TOPICAL THERAPY IN ADOLESCENT PARTICIPANTS 12 TO <18 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
3 other identifiers
interventional
287
14 countries
136
Brief Summary
This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to \<18 years of age with moderate to severe AD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2019
Shorter than P25 for phase_3
136 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
January 4, 2019
CompletedFirst Posted
Study publicly available on registry
January 8, 2019
CompletedStudy Start
First participant enrolled
February 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2020
CompletedResults Posted
Study results publicly available
June 4, 2021
CompletedApril 13, 2022
April 1, 2022
1.1 years
January 4, 2019
March 18, 2021
April 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12
The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
Baseline to Week 12
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Baseline to Week 12
Secondary Outcomes (40)
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12
Baseline, Weeks 2, 4 and 12
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12
Baseline to Week 12
Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
Baseline, Weeks 2, 4 and 8
Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12
Baseline, Weeks 2, 4 and 8
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline
Baseline, Weeks 2, 4, 8 and 12
- +35 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo
PF-04965842 100 mg QD
EXPERIMENTALactive
PF-04965842 200 mg QD
EXPERIMENTALactive
Interventions
Eligibility Criteria
You may qualify if:
- Aged between 12 and to 17 with a minimum body weight of 40 kg
- 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)
You may not qualify if:
- Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
- Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
- Prior treatment with JAK inhibitors
- 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 (136)
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, 35244, United States
Madera Family Medical Group
Madera, California, 93637, United States
Allergy & Asthma Associates of Southern California dba Southern California Research
Mission Viejo, California, 92691, United States
UC Davis
Sacramento, California, 95816, United States
Moonshine Research Center, Inc.
Doral, Florida, 33166, United States
Homestead Research Institute
Homestead, Florida, 33030, United States
Olympian Clinical Research
Largo, Florida, 33770, United States
Clinical Trials Solutions
Miami, Florida, 33126, United States
Global Health Clinical Trials Corp
Miami, Florida, 33135, United States
La Salud Research Clinic, Inc.
Miami, Florida, 33155, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
South Miami Medical & Research Group, Inc.
Miami, Florida, 33155, United States
Ciocca Dermatology, PA
Miami, Florida, 33173, United States
INTERMED Medical Research Center, Inc
Miami, Florida, 33175, United States
Suncoast Research Associates
Miami, Florida, 33184, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
AdventHealth Pediatric Dermatology Orlando
Orlando, Florida, 32803, United States
AdventHealth Orlando - Investigational Drug Services
Orlando, Florida, 32804, United States
Outpatient Service Center-AdventHealth Orlando
Orlando, Florida, 32804, United States
Pediatric Outpatient Procedures and Sedation
Orlando, Florida, 32804, United States
NeuroSkeletal Imaging
Orlando, Florida, 32806, United States
Accel Research Sites - Pure Skin Dermatology & Aesthetics
Orlando, Florida, 32819, United States
Accel Research Sites - Nona Pediatric Center
Orlando, Florida, 32829, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406, United States
Midwest Allergy Sinus Asthma, SC
Normal, Illinois, 61761, United States
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie, Illinois, 60077, 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
Forefront Dermatology S.C.
Louisville, Kentucky, 40202, United States
Institute for Asthma and Allergy
Chevy Chase, Maryland, 20815, United States
DermAssociates, LLC
Rockville, Maryland, 20850, United States
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162, United States
Clarkston Skin Research
Clarkston, Michigan, 48346, United States
Wayne State University / Integrative Biosciences Center
Detroit, Michigan, 48202, United States
Center for Outpatient Health
St Louis, Missouri, 63108, United States
St. Louis Children's Hospital
St Louis, Missouri, 63108, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Clinical Research Consortium
Las Vegas, Nevada, 89119, United States
DermResearch Center of New York, Inc.
Stony Brook, New York, 11790, United States
Synexus Clinical Research US, Inc.
Cincinnati, Ohio, 45236, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Synexus Clinical Research US, Inc.
Anderson, South Carolina, 29621, United States
Synexus Clinical Research US, Inc.
Greer, South Carolina, 29651, United States
Austin Institute for Clinical Research, Inc.
Austin, Texas, 78705, United States
Center for Clinical Studies, LTD.LLP
Webster, Texas, 77598, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, 23502, United States
West Virginia Research Institute
Morgantown, West Virginia, 26505, United States
Children's Hospital of Wisconsin Investigational Drug Service
Milwaukee, Wisconsin, 53226, United States
Children's Hospital of Wisconsin Translational Research Unit
Milwaukee, Wisconsin, 53226, United States
Australian Clinical Research Network
Maroubra, New South Wales, 2035, Australia
The Skin Hospital
Westmead, New South Wales, 2145, Australia
The Skin Centre
Benowa, Queensland, 4217, Australia
The Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Sinclair Dermatology
East Melbourne, Victoria (vic), 3002, Australia
The First Affiliated Hospital of Fujian Medical University, Dermatology Department
Fuzhou, Fujian, 350005, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, 330000, China
Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin
Jinan, Shandong, 250022, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Hangzhou Third Hospital
Hangzhou, Zhejiang, 310009, China
The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept
Hangzhou, Zhejiang, 310009, China
Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology
Shanghai, 200092, China
Shanghai Dermatology Hospital
Shanghai, 200443, China
Lekarna Na Vaclavskem namesti
Kutná Hora, 284 01, Czechia
Kozni ambulance Kutna Hora, s.r.o
Kutná Hora, 28401, Czechia
Dermamedica S.R.O.
Náchod, 547 01, Czechia
Oblastni nemocnice Nachod
Náchod, 547 01, Czechia
Lekarna u Stribrneho orla
Náchod, 54701, Czechia
Mestska poliklinika Praha
Prague, 110 00, Czechia
Lekarna Cisarska
Prague, 120 00, Czechia
Synexus Czech S.R.O.
Prague, 120 00, Czechia
Dermatovenerologicka ambulance
Svitavy, 56802, Czechia
Lekarna na Hranicni
Svitavy, 56802, Czechia
Nemocnice Svitavy
Svitavy, 56825, Czechia
Universitaetsklinikum Bonn
Bonn, North Rhine-Westphalia, 53105, Germany
Fachklinik Bad Bentheim Thermalsole- und Schwefelbad Bentheim GmbH
Bad Bentheim, 48455, Germany
Universitaetsklinikum Bonn
Bonn, 53127, Germany
MENSINGDERMA research GmbH
Hamburg, 22391, Germany
Uniklinik Muenster
Münster, 48149, Germany
Clinexpert Kft.
Budapest, 1033, Hungary
Bugát Pál Kórház, Bőrgyógyászati Szakrendelés
Gyöngyös, 3200, Hungary
Trial Pharma Kft.
Győr, 9026, Hungary
Trial Pharma Kft.
Kaposvár, 7400, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Gyermek Gasztroenterológia II. emelet
Miskolc, 3526, Hungary
Trial Pharma Kft.
Püspökladány, 4150, Hungary
Istituto Clinico Humanitas IRCSS - UOC di Dermatologia
Milan, 20089, Italy
Takagi Dermatological Clinic
Obihiro, Hokkaido, 080-0013, Japan
Dermatology Shimizu Clinic
Kobe, Hyōgo, 657-0846, Japan
Noguchi Dermatology Clinic
Kamimashiki-gun, Kumamoto, 861-3101, Japan
Yoshioka Dermatology Clinic
Neyagawa, Osaka, 572-0838, Japan
Kume Clinic
Sakai, Osaka, 593-8324, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
Hoshikuma Dermatology・Allergy Clinic
Fukuoka, 814-0171, Japan
Matsuda Tomoko Dermatological Clinic
Fukuoka, 819-0167, Japan
Aesthetic dermatology clinic of Prof. J. Kisis
Riga, LV-1003, Latvia
Outpatient Clinic Of Ventspils
Ventspils, LV-3601, Latvia
Clinical Research Institute Saltillo S.A. de C.V.
Saltillo, Coahuila, 25020, Mexico
Trials in Medicine S.C.
Cuauhtémoc, Mexico City, 06700, Mexico
Hospital Infantil de México Federico Gómez
Del. Cuauhtemoc, Mexico City, 06720, Mexico
Hospital de Jesus, I.A.P.
Del. Cuauhtémoc, Mexico City, 06090, Mexico
Unidad de Atención Médica e Investigación en Salud
Mérida, Yucatán, 97000, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
Mérida, Yucatán, 97130, Mexico
Servicios Hospitalarios de Mexico S.A. de C.V. (Hospital Ángeles Chihuahua)
Chihuahua City, 31238, Mexico
Sociedad de Metabolismo y Corazón S.C.
Veracruz, 91900, Mexico
KLIMED Marek Klimkiewicz
Bialystok, 15-704, Poland
Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny i Alergologiczny
Bydgoszcz, 85-650, Poland
Centrum Medyczne SENSEMED
Chorzów, 41-500, Poland
Centrum Medyczne Pratia Czestochowa
Częstochowa, 42-200, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna "A-DERM-SERWIS"
Częstochowa, 42-217, Poland
Neutrum Lekarze M. Hlebowicz i Partnerzy Spolka Partnerska
Gdansk, 80-462, Poland
MULTIKLINIKA Salute Sp. z o.o.
Katowice, 40-123, Poland
Centrum Medyczne Angelius Provita
Katowice, 40-611, Poland
Centrum medyczne PLEJADY
Krakow, 30-363, Poland
Krakowskie Centrum Medyczne
Krakow, 31-501, Poland
Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
Lodz, 90-436, Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, 27-400, Poland
Irmed
Piotrkow Trybunalski, 97-300, Poland
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, 60-702, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, 01-192, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, 50-381, Poland
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, LAS Palmas, 35010, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital De La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Consultas Externas Dermatologia Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Servicio de Radiologia Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, S75 2EP, United Kingdom
Related Publications (4)
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.
PMID: 40028832DERIVEDArmstrong 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.
PMID: 38896380DERIVEDCork 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.
PMID: 34743361DERIVEDEichenfield LF, Flohr C, Sidbury R, Siegfried E, Szalai Z, Galus R, Yao Z, Takahashi H, Barbarot S, Feeney C, Zhang F, DiBonaventura M, Rojo R, Valdez H, Chan G. Efficacy and Safety of Abrocitinib in Combination With Topical Therapy in Adolescents With Moderate-to-Severe Atopic Dermatitis: The JADE TEEN Randomized Clinical Trial. JAMA Dermatol. 2021 Oct 1;157(10):1165-1173. doi: 10.1001/jamadermatol.2021.2830.
PMID: 34406366DERIVED
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
January 4, 2019
First Posted
January 8, 2019
Study Start
February 18, 2019
Primary Completion
April 8, 2020
Study Completion
April 8, 2020
Last Updated
April 13, 2022
Results First Posted
June 4, 2021
Record last verified: 2022-04
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.