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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: PF-04965842; Drug: PF04965842

Detailed Description

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. Participants will be screened within 28 days prior to the first dose of study intervention to confirm study eligibility. Subjects must have moderate-severe AD involving at least 10% Body Surface Area (BSA); an Investigator Global Assessment (IGA) score of at least 3; an Eczema Area Severity Index (EASI) of at least 16 and Peak Pruritus Numerical Rating Score (NRS) of at least 4 on baseline/Day 1. Eligible subjects will be randomized at the Baseline/Day 1 visit. Approximately 225 participants will be randomized in a 1:1:1 ratio to receive once daily PF 04965842 at 200 mg, 100 mg, or placebo for 12 weeks. Randomization will be stratified by baseline disease severity (moderate [IGA = 3] vs. severe [IGA = 4] AD). The investigational products will be administered QD for 12 weeks. Background therapy (medicated and non-medicated topical therapy) must be applied BID for the duration of the treatment period. The co-primary efficacy endpoints are an IGA score of clear (0) or almost clear (1) with a reduction from baseline of greater than 2 points at Week 12 AND an at least 75% improvement of the EASI score (EASI-75) at week 12. Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment. Scheduled clinic or telephone study visits for all subjects will occur at Screening, Baseline/Day 1, Day 8 (by phone), Day 15, Day 29, Day 43 (by phone), Day 57, Day 85 (End of treatment/Early termination), Day 113 (End of Study). Participants discontinuing early from the study will undergo a 4 week follow up period.

This study includes an immunogenicity sub study integrated into the last 4 weeks of the main study treatment period. At Week 8, up to approximately 90 participants (up to approximately 30 in each treatment arm) who have completed 8 weeks of treatment with study intervention will receive a tetanus, diphtheria and acellular pertussis combination vaccine (Tdap), and collection of blood samples for the evaluation of immunogenicity at Weeks 8 and 12. Participants of this sub study will complete all other protocol specified procedures in the main study.

At the end of the 12 week study treatment, qualified participants completing the study will have the option to enter the long term extension (LTE) study B7451015.

• Study Type: Interventional
• Enrollment (Actual): 287
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Maroubra, New South Wales, Australia, 2035
      • Australian Clinical Research Network
    • Westmead, New South Wales, Australia, 2145
      • The Skin Hospital
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • The Skin Centre
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • The Royal Children's Hospital
  • Victoria (vic)
    • East Melbourne, Victoria (vic), Australia, 3002
      • Sinclair Dermatology
• China
  • Shanghai, China, 200443
    • Shanghai Dermatology Hospital
  • Shanghai, China, 200092
    • Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital of Fujian Medical University, Dermatology Department
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Dermatology Hospital of Jiangxi Province
  • Shandong
    • Jinan, Shandong, China, 250022
      • Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital Fudan University
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Hangzhou Third Hospital
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept
• Czechia
  • Kutna Hora, Czechia, 284 01
    • Lekarna Na Vaclavskem namesti
  • Kutna Hora, Czechia, 28401
    • Kozni ambulance Kutna Hora, s.r.o
  • Nachod, Czechia, 547 01
    • Dermamedica S.R.O.
  • Nachod, Czechia, 54701
    • Lekarna u Stribrneho orla
  • Nachod, Czechia, 547 01
    • Oblastni nemocnice Nachod
  • Praha, Czechia, 110 00
    • Mestska poliklinika Praha
  • Praha 2, Czechia, 120 00
    • Synexus Czech s.r.o.
  • Praha 2, Czechia, 120 00
    • Lekarna Cisarska
  • Svitavy, Czechia, 56802
    • Lekarna na Hranicni
  • Svitavy, Czechia, 56802
    • Dermatovenerologicka ambulance
  • Svitavy, Czechia, 56825
    • Nemocnice Svitavy
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim Thermalsole- und Schwefelbad Bentheim GmbH
  • Bonn, Germany, 53127
    • Universitaetsklinikum Bonn
  • Hamburg, Germany, 22391
    • Mensingderma Research Gmbh
  • Muenster, Germany, 48149
    • Uniklinik Muenster
  • NRW
    • Bonn, NRW, Germany, 53105
      • Universitaetsklinikum Bonn
• Hungary
  • Budapest, Hungary, 1033
    • Clinexpert Kft.
  • Gyöngyös, Hungary, 3200
    • Bugát Pál Kórház, Bőrgyógyászati Szakrendelés
  • Győr, Hungary, 9026
    • Trial Pharma Kft.
  • Kaposvár, Hungary, 7400
    • Trial Pharma Kft.
  • Miskolc, Hungary, 3526
    • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Gyermek Gasztroenterológia II. emelet
  • Püspökladány, Hungary, 4150
    • Trial Pharma Kft.
• Italy
  • Milano, Italy, 20089
    • Istituto Clinico Humanitas IRCSS - UOC di Dermatologia
• Japan
  • Fukuoka, Japan, 814-0171
    • Hoshikuma Dermatology・Allergy Clinic
  • Fukuoka, Japan, 819-0167
    • Matsuda Tomoko Dermatological Clinic
  • Hokkaido
    • Obihiro, Hokkaido, Japan, 080-0013
      • Takagi Dermatological Clinic
  • Hyogo
    • Kobe, Hyogo, Japan, 657-0846
      • Dermatology Shimizu Clinic
  • Kumamoto
    • Kamimashiki-gun, Kumamoto, Japan, 861-3101
      • Noguchi Dermatology Clinic
  • Osaka
    • Neyagawa, Osaka, Japan, 572-0838
      • Yoshioka Dermatology Clinic
    • Sakai, Osaka, Japan, 593-8324
      • Kume Clinic
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Fukuwa Clinic
• Latvia
  • Riga, Latvia, LV-1003
    • Aesthetic dermatology clinic of Prof. J. Kisis
  • Ventspils, Latvia, LV-3601
    • Outpatient Clinic Of Ventspils
• Mexico
  • Chihuahua, Mexico, 31238
    • Servicios Hospitalarios de Mexico S.A. de C.V. (Hospital Ángeles Chihuahua)
  • Veracruz, Mexico, 91900
    • Sociedad de Metabolismo y Corazon S.C.
  • Ciudad DE Mexico
    • Del. Cuauhtemoc, Ciudad DE Mexico, Mexico, 06720
      • Hospital Infantil de Mexico Federico Gomez
    • Del. Cuauhtémoc, Ciudad DE Mexico, Mexico, 06090
      • Hospital de Jésus, I.A.P.
  • Ciudad DE México
    • Cuauhtemoc, Ciudad DE México, Mexico, 06700
      • Trials in Medicine S.C.
  • Coahuila
    • Saltillo, Coahuila, Mexico, 25020
      • Clinical Research Institute Saltillo S.A. de C.V.
  • Yucatan
    • Merida, Yucatan, Mexico, 97000
      • Unidad de Atencion Medica e Investigacion en Salud
    • Merida, Yucatan, Mexico, 97130
      • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
• Poland
  • Bialystok, Poland, 15-704
    • KLIMED Marek Klimkiewicz
  • Bydgoszcz, Poland, 85-650
    • Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny i Alergologiczny
  • Chorzow, Poland, 41-500
    • Centrum Medyczne Sensemed
  • Czestochowa, Poland, 42-200
    • Centrum Medyczne Pratia Czestochowa
  • Czestochowa, Poland, 42-217
    • Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna "A-DERM-SERWIS"
  • Gdansk, Poland, 80-462
    • Neutrum Lekarze M. Hlebowicz i Partnerzy Spolka Partnerska
  • Katowice, Poland, 40-611
    • Centrum Medyczne Angelius Provita
  • Katowice, Poland, 40-123
    • MULTIKLINIKA Salute Sp. z o.o.
  • Krakow, Poland, 30-363
    • Centrum Medyczne Plejady
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne
  • Lodz, Poland, 90-436
    • Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
  • Ostrowiec Swietokrzyski, Poland, 27-400
    • Dermedic Jacek Zdybski
  • Piotrkow Trybunalski, Poland, 97-300
    • IRMED
  • Poznan, Poland, 60-702
    • Synexus Polska Sp. z o.o. Oddzial w Poznaniu
  • Warszawa, Poland, 01-192
    • Synexus Polska Sp. z o.o. Oddzial w Warszawie
  • Wroclaw, Poland, 50-381
    • Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Zaragoza, Spain, 50009
    • Consultas Externas Dermatologia Hospital Universitario Miguel Servet
  • Zaragoza, Spain, 50009
    • Servicio de Radiologia Hospital Universitario Miguel Servet
  • LAS Palmas
    • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35010
      • Hospital Universitario de Gran Canaria Dr. Negrin
• Taiwan
  • Taichung, Taiwan, 402
    • Chung Shan Medical University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• United Kingdom
  • South Yorkshire
    • Barnsley, South Yorkshire, United Kingdom, S75 2EP
      • Barnsley Hospital NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Clinical Research Center of Alabama, LLC
  • California
    • Madera, California, United States, 93637
      • Madera Family Medical Group
    • Mission Viejo, California, United States, 92691
      • Allergy & Asthma Associates of Southern California dba Southern California Research
    • Sacramento, California, United States, 95816
      • UC Davis
  • Florida
    • Doral, Florida, United States, 33166
      • Moonshine Research Center, Inc.
    • Homestead, Florida, United States, 33030
      • Homestead Research Institute
    • Largo, Florida, United States, 33770
      • Olympian Clinical Research
    • Miami, Florida, United States, 33155
      • Nicklaus Children's Hospital
    • Miami, Florida, United States, 33135
      • Global Health Clinical Trials Corp
    • Miami, Florida, United States, 33126
      • Clinical Trials Solutions
    • Miami, Florida, United States, 33155
      • La Salud Research Clinic, Inc.
    • Miami, Florida, United States, 33155
      • South Miami Medical & Research Group, Inc.
    • Miami, Florida, United States, 33173
      • Ciocca Dermatology, PA
    • Miami, Florida, United States, 33175
      • INTERMED Medical Research Center, Inc
    • Miami, Florida, United States, 33184
      • Suncoast Research Associates
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
    • Orlando, Florida, United States, 32804
      • AdventHealth Orlando - Investigational Drug Services
    • Orlando, Florida, United States, 32803
      • AdventHealth Pediatric Dermatology Orlando
    • Orlando, Florida, United States, 32804
      • Pediatric Outpatient Procedures and Sedation
    • Orlando, Florida, United States, 32829
      • Accel Research Sites - Nona Pediatric Center
    • Orlando, Florida, United States, 32819
      • Accel Research Sites - Pure Skin Dermatology & Aesthetics
    • Orlando, Florida, United States, 32804
      • Outpatient Service Center-AdventHealth Orlando
    • Orlando, Florida, United States, 32806
      • NeuroSkeletal Imaging
    • Tampa, Florida, United States, 33613
      • ForCare Clinical Research
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research, LLC
  • Illinois
    • Normal, Illinois, United States, 61761
      • Midwest Allergy Sinus Asthma, Sc
    • Skokie, Illinois, United States, 60077
      • NorthShore University HealthSystem Dermatology Clinical Trials Unit
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic Center for Research
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Forefront Dermatology S.C.
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Institute for Asthma and Allergy
    • Rockville, Maryland, United States, 20850
      • DermAssociates, LLC
    • White Marsh, Maryland, United States, 21162
      • Chesapeake Clinical Research, Inc.
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Clarkston Skin Research
    • Detroit, Michigan, United States, 48202
      • Wayne State University / Integrative Biosciences Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital
    • Saint Louis, Missouri, United States, 63108
      • Center for Outpatient Health
    • Saint Louis, Missouri, United States, 63108
      • St. Louis Children's Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Clinical Research Consortium
  • New York
    • Stony Brook, New York, United States, 11790
      • DermResearch Center of New York, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Synexus Clinical Research US, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Science Center
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Synexus Clinical Research US, Inc.
    • Greer, South Carolina, United States, 29651
      • Synexus Clinical Research US, Inc.
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Institute for Clinical Research, Inc.
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies, LTD.LLP
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research, Inc
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • West Virginia Research Institute
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital of Wisconsin Investigational Drug Service
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital of Wisconsin Translational Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo
EXPERIMENTAL: PF-04965842 100 mg QD; active	Drug: PF-04965842; 100 mg QD
EXPERIMENTAL: PF-04965842 200 mg QD; active	Drug: PF04965842; 200 mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder.	Baseline, Weeks 2, 4 and 12
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12	The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep & Usual Activities Questions and Patient Global Impression of Severity & Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms.	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	The IGA of AD is 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, Weeks 2, 4 and 8
Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12	The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of 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, Weeks 2, 4 and 8
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline	The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of 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, Weeks 2, 4, 8 and 12
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline	The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of 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, Weeks 2, 4, 8 and 12
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline	The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of 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, Weeks 2, 4, 8 and 12
Percent Change From Baseline in EASI Score	The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of 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, Weeks 2, 4, 8 and 12
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12	PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder.	Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus	PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10).	Baseline to Week 16
Percent Change From Baseline in PP-NRS for Severity of Pruritus	PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10).	Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Change From Baseline in Percentage Body Surface Area (BSA)	BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.	Baseline, Weeks 2, 4, 8 and 12
Percent Change From Baseline in Percentage BSA	BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.	Baseline, Weeks 2, 4, 8 and 12
Percentage of Participants Achieving Percentage BSA < 5% at Week 12	BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.	Baseline to Week 12
Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline	SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.	Baseline, Weeks 2, 4, 8 and 12
Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline	SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.	Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in SCORAD Total Score	SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.	Baseline, Weeks 2, 4, 8 and 12
Percent Change From Baseline in SCORAD Total Score	SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.	Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss	SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.	Baseline, Weeks 2, 4, 8 and 12
Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss	SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.	Baseline, Weeks 2, 4, 8 and 12
Number of Days When a Corticosteroid Not Used up to Day 88		Baseline to Day 88
Change From Baseline in Children's Dermatology Life Quality Index (DLQI)	The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.	Baseline, Weeks 2, 4, 8 and 12
Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI	The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.	Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS)	The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.	Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Depression of HADS	The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.	Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Patient-Oriented Eczema Measure (POEM)	The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD.	Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Dermatitis Family Impact (DFI) at Week 12	The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" or "not at all (0)". The score can range from 0 to 30. The higher values represent the worse impact.	Baseline to Week 12
Change From Baseline in Patient Global Assessment (PtGA)	The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.	Baseline, Weeks 2, 4, 8 and 12
Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA	The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.	Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score	The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine).	Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12	The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated.	Baseline to Week 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.	16 weeks
Number of Participants With Serious Adverse Events (SAEs)	A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.	16 weeks
Number of Participants Who Discontinued From the Study Due to TEAEs	An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.	16 weeks
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal.	16 weeks
Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria	A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to >500 ms or >60 ms change from screening ECG); data are presented below.	16 weeks
Categorization of Vital Signs Data Meeting Prespecified Criteria	Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes.	16 weeks
Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination	The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution.	4 weeks post-vaccination with Tdap (Week 12)
Plasma PF-04965842 Concentration at Week 8		2 hours pre-dose at Week 8
Plasma PF-04965842 Concentration at Week 12		2 hours post-dose at Week 12

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.
• Eichenfield 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. Erratum In: JAMA Dermatol. 2021 Oct 1;157(10):1246.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2019
• Primary Completion (ACTUAL): April 8, 2020
• Study Completion (ACTUAL): April 8, 2020

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (ACTUAL): January 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Atopic Dermatitis, JAK1 inhibitor
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Abrocitinib
• Other Study ID Numbers: B7451036; JADE TEEN (OTHER: Alias Study Number); 2018-003804-37 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No