Clinical trial NCT03796676: JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis, JAK1 inhibitor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-01-08
Enrollment: 287
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline to Week 12
measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: 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
timeFrame: Baseline, Weeks 2, 4 and 12
measure: Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12
timeFrame: Baseline to Week 12
measure: 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
timeFrame: Baseline, Weeks 2, 4 and 8
measure: Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12
timeFrame: Baseline, Weeks 2, 4 and 8
measure: Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Percentage of Participants Achieving EASI Response =100% Improvement From Baseline
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Percent Change From Baseline in EASI Score
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: 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
timeFrame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
measure: Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline in PP-NRS for Severity of Pruritus
timeFrame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
measure: Change From Baseline in Percentage Body Surface Area (BSA)
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Percent Change From Baseline in Percentage BSA
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Percentage of Participants Achieving Percentage BSA < 5% at Week 12
timeFrame: Baseline to Week 12
measure: Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Change From Baseline in SCORAD Total Score
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Percent Change From Baseline in SCORAD Total Score
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Number of Days When a Corticosteroid Not Used up to Day 88
timeFrame: Baseline to Day 88
measure: Change From Baseline in Children's Dermatology Life Quality Index (DLQI)
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Change From Baseline in Depression of HADS
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM)
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Change From Baseline in Dermatitis Family Impact (DFI) at Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Patient Global Assessment (PtGA)
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12
timeFrame: Baseline to Week 12
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: 16 weeks
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: 16 weeks
measure: Number of Participants Who Discontinued From the Study Due to TEAEs
timeFrame: 16 weeks
measure: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
timeFrame: 16 weeks
measure: Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria
timeFrame: 16 weeks
measure: Categorization of Vital Signs Data Meeting Prespecified Criteria
timeFrame: 16 weeks
measure: Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination
timeFrame: 4 weeks post-vaccination with Tdap (Week 12)
measure: Plasma PF-04965842 Concentration at Week 8
timeFrame: 2 hours pre-dose at Week 8
measure: Plasma PF-04965842 Concentration at Week 12
timeFrame: 2 hours post-dose at Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama, LLC
state: Alabama
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Mission Viejo
country: United States
facility: Allergy & Asthma Associates of Southern California dba Southern California Research
state: California
city: Sacramento
country: United States
facility: UC Davis
state: California
city: Doral
country: United States
facility: Moonshine Research Center, Inc.
state: Florida
city: Homestead
country: United States
facility: Homestead Research Institute
state: Florida
city: Largo
country: United States
facility: Olympian Clinical Research
state: Florida
city: Miami
country: United States
facility: Clinical Trials Solutions
state: Florida
city: Miami
country: United States
facility: Global Health Clinical Trials Corp
state: Florida
city: Miami
country: United States
facility: La Salud Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
city: Miami
country: United States
facility: South Miami Medical & Research Group, Inc.
state: Florida
city: Miami
country: United States
facility: Ciocca Dermatology, PA
state: Florida
city: Miami
country: United States
facility: INTERMED Medical Research Center, Inc
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Orlando
country: United States
facility: AdventHealth Pediatric Dermatology Orlando
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando - Investigational Drug Services
state: Florida
city: Orlando
country: United States
facility: Outpatient Service Center-AdventHealth Orlando
state: Florida
city: Orlando
country: United States
facility: Pediatric Outpatient Procedures and Sedation
state: Florida
city: Orlando
country: United States
facility: NeuroSkeletal Imaging
state: Florida
city: Orlando
country: United States
facility: Accel Research Sites - Pure Skin Dermatology & Aesthetics
state: Florida
city: Orlando
country: United States
facility: Accel Research Sites - Nona Pediatric Center
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Normal
country: United States
facility: Midwest Allergy Sinus Asthma, SC
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem Dermatology Clinical Trials Unit
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic Center for Research
state: Indiana
city: Louisville
country: United States
facility: Forefront Dermatology S.C.
state: Kentucky
city: Chevy Chase
country: United States
facility: Institute for Asthma and Allergy
state: Maryland
city: Rockville
country: United States
facility: DermAssociates, LLC
state: Maryland
city: White Marsh
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Clarkston
country: United States
facility: Clarkston Skin Research
state: Michigan
city: Detroit
country: United States
facility: Wayne State University / Integrative Biosciences Center
state: Michigan
city: Saint Louis
country: United States
facility: Center for Outpatient Health
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Consortium
state: Nevada
city: Stony Brook
country: United States
facility: DermResearch Center of New York, Inc.
state: New York
city: Cincinnati
country: United States
facility: Synexus Clinical Research US, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc.
state: South Carolina
city: Greer
country: United States
facility: Synexus Clinical Research US, Inc.
state: South Carolina
city: Austin
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies, LTD.LLP
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc
state: Virginia
city: Morgantown
country: United States
facility: West Virginia Research Institute
state: West Virginia
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin Investigational Drug Service
state: Wisconsin
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin Translational Research Unit
state: Wisconsin
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Westmead
country: Australia
facility: The Skin Hospital
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria (vic)
city: Parkville
country: Australia
facility: The Royal Children's Hospital
state: Victoria
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University, Dermatology Department
state: Fujian
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanchang
country: China
facility: Dermatology Hospital of Jiangxi Province
state: Jiangxi
city: Jinan
country: China
facility: Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou Third Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept
state: Zhejiang
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
city: Kutna Hora
country: Czechia
facility: Lekarna Na Vaclavskem namesti
city: Kutna Hora
country: Czechia
facility: Kozni ambulance Kutna Hora, s.r.o
city: Nachod
country: Czechia
facility: Dermamedica S.R.O.
city: Nachod
country: Czechia
facility: Oblastni nemocnice Nachod
city: Nachod
country: Czechia
facility: Lekarna u Stribrneho orla
city: Praha 2
country: Czechia
facility: Lekarna Cisarska
city: Praha 2
country: Czechia
facility: Synexus Czech S.R.O.
city: Praha
country: Czechia
facility: Mestska poliklinika Praha
city: Svitavy
country: Czechia
facility: Dermatovenerologicka ambulance
city: Svitavy
country: Czechia
facility: Lekarna na Hranicni
city: Svitavy
country: Czechia
facility: Nemocnice Svitavy
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
state: NRW
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim Thermalsole- und Schwefelbad Bentheim GmbH
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Hamburg
country: Germany
facility: MENSINGDERMA research GmbH
city: Muenster
country: Germany
facility: Uniklinik Muenster
city: Budapest
country: Hungary
facility: Clinexpert Kft.
city: Gyöngyös
country: Hungary
facility: Bugát Pál Kórház, Bőrgyógyászati Szakrendelés
city: Győr
country: Hungary
facility: Trial Pharma Kft.
city: Kaposvár
country: Hungary
facility: Trial Pharma Kft.
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Gyermek Gasztroenterológia II. emelet
city: Püspökladány
country: Hungary
facility: Trial Pharma Kft.
city: Milano
country: Italy
facility: Istituto Clinico Humanitas IRCSS - UOC di Dermatologia
city: Obihiro
country: Japan
facility: Takagi Dermatological Clinic
state: Hokkaido
city: Kobe
country: Japan
facility: Dermatology Shimizu Clinic
state: Hyogo
city: Kamimashiki-gun
country: Japan
facility: Noguchi Dermatology Clinic
state: Kumamoto
city: Neyagawa
country: Japan
facility: Yoshioka Dermatology Clinic
state: Osaka
city: Sakai
country: Japan
facility: Kume Clinic
state: Osaka
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Hoshikuma Dermatology・Allergy Clinic
city: Fukuoka
country: Japan
facility: Matsuda Tomoko Dermatological Clinic
city: Riga
country: Latvia
facility: Aesthetic dermatology clinic of Prof. J. Kisis
city: Ventspils
country: Latvia
facility: Outpatient Clinic Of Ventspils
city: Del. Cuauhtemoc
country: Mexico
facility: Hospital Infantil de México Federico Gómez
state: Ciudad DE Mexico
city: Del. Cuauhtémoc
country: Mexico
facility: Hospital de Jesus, I.A.P.
state: Ciudad DE Mexico
city: Cuauhtemoc
country: Mexico
facility: Trials in Medicine S.C.
state: Ciudad DE México
city: Saltillo
country: Mexico
facility: Clinical Research Institute Saltillo S.A. de C.V.
state: Coahuila
city: Merida
country: Mexico
facility: Unidad de Atención Médica e Investigación en Salud
state: Yucatan
city: Merida
country: Mexico
facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
state: Yucatan
city: Chihuahua
country: Mexico
facility: Servicios Hospitalarios de Mexico S.A. de C.V. (Hospital Ángeles Chihuahua)
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazón S.C.
city: Bialystok
country: Poland
facility: KLIMED Marek Klimkiewicz
city: Bydgoszcz
country: Poland
facility: Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny i Alergologiczny
city: Chorzow
country: Poland
facility: Centrum Medyczne SENSEMED
city: Czestochowa
country: Poland
facility: Centrum Medyczne Pratia Czestochowa
city: Czestochowa
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna "A-DERM-SERWIS"
city: Gdansk
country: Poland
facility: Neutrum Lekarze M. Hlebowicz i Partnerzy Spolka Partnerska
city: Katowice
country: Poland
facility: MULTIKLINIKA Salute Sp. z o.o.
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Krakow
country: Poland
facility: Centrum medyczne PLEJADY
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne
city: Lodz
country: Poland
facility: Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Piotrkow Trybunalski
country: Poland
facility: Irmed
city: Poznan
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Poznaniu
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrin
state: LAS Palmas
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Zaragoza
country: Spain
facility: Consultas Externas Dermatologia Hospital Universitario Miguel Servet
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Zaragoza
country: Spain
facility: Servicio de Radiologia Hospital Universitario Miguel Servet
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.