JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis (JADE TEEN)

• ClinicalTrials.gov Identifier: NCT03796676
• Recruitment Status: Completed
• First Posted: January 8, 2019
• Last Update Posted: August 12, 2020
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: Placebo; Drug: PF-04965842; Drug: PF04965842	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 287 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 18, 2019
• Actual Primary Completion Date: April 8, 2020
• Actual Study Completion Date: April 8, 2020

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; 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

Outcome Measures

Primary Outcome Measures :

1. Change from baseline response based on IGA score of 0 or 1 and a reduction from baseline of at least 2 points. [ Time Frame: Day 1 (Baseline), Week 12 (end of treatment/early termination). ]
   Investigator's Global Assessment (IGA) assessed the severity of AD (except scalp, palms and soles) on a 5-point scale ranged from 0 (clear) to 4 (severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (AD is cleared, except for any residual discoloration, post-inflammatory hyperpigmentation and/or hypopigmentation), 1= almost clear, 2= mild , 3= moderate and 4= severe. Percentage of participants with an ISGA score of 0 or 1 were reported.
2. Change from baseline response based on the Eczema Area and Severity Index of more than 75% improvement from baseline (EASI-75). [ Time Frame: Day 1 (Baseline), Week 12 (end of treatment/early termination). ]
   The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.

Secondary Outcome Measures :

1. Change from baseline response based on at least 4 points improvement in the Peak Pruritus NRS [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 12 (end of treatment/early termination). ]
   Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point Numeric Rating Score (NRS) where 0 is no pruritus and 10 is most severe possible pruritus. Change: score at observation minus score at baseline.
2. Change from baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) total score [ Time Frame: Day 1 (Baseline), Week 12 (end of treatment/early termination). ]
   The PSAAD is a daily patient reported symptom diary. The version is a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, capturing those identified by patients to be most important, based on a 24 hour recall. Analysis of the PSAAD will be based solely on these 11 items.
3. Change from baseline response based on at least 4 points improvement in the Peak Pruritus NRS [ Time Frame: Day 1 (Baseline), Days 2-14, Week 8, Week 16 (end of study). ]
   Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point Numeric Rating Score (NRS) where 0 is no pruritus and 10 is most severe possible pruritus. Change: score at observation minus score at baseline.
4. Time to achieve at least 4 points improvement in the Peak Pruritus NRS from baseline [ Time Frame: Day 1 (Baseline), Days 2-14, Day 15 (week 2) ]
   Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point Numeric Rating Score (NRS) where 0 is no pruritus and 10 is most severe possible pruritus. Change: score at observation minus score at baseline.
5. Change from baseline response based on the Eczema Area and Severity Index of more than 75% improvement from baseline (EASI-75). [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 16 (end of study). ]
   The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.
6. Change from baseline response based on Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and a reduction from baseline of at least 2 points. [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 16 (end of study). ]
   Investigator's Global Assessment (IGA) assessed the severity of AD (except scalp, palms and soles) on a 5-point scale ranged from 0 (clear) to 4 (severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (AD is cleared, except for any residual discoloration, post-inflammatory hyperpigmentation and/or hypopigmentation), 1= almost clear, 2= mild , 3= moderate and 4= severe. Percentage of participants with an ISGA score of 0 or 1 were reported.
7. Change from baseline response based on the Eczema Area and Severity Index of more than 50% improvement from baseline (EASI-50). [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 (end of treatment/early termination), Week 16 (end of study). ]
   The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.
8. Change from baseline response based on the Eczema Area and Severity Index of more than 90% improvement from baseline (EASI-90). [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 (end of treatment/early termination), Week 16 (end of study). ]
   The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.
9. Change from baseline response based on the Eczema Area and Severity Index of 100% improvement from baseline (EASI-100). [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 (end of treatment/early termination), Week 16 (end of study). ]
   The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.
10. Change from baseline in the percentage Body Surface Area (%BSA) [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 (end of treatment/early termination), Week 16 (end of study). ]
    The number of handprints of AD skin in a body region can be used to determine the extent (%) to which a body region is involved with atopic dermatitis. The area represented by the palmar surface of the subject's hand with all five digits adducted together, is approximately 1% of the subject's BSA, regardless of the subject's age. BSA in handprints across 4 body regions assessed as part of the EASI assessment.
11. Proportion of participants with affected BSA <5% [ Time Frame: Day 1 (Baseline), Week 12 (end of treatment/early termination). ]
    The number of handprints of AD skin in a body region can be used to determine the extent (%) to which a body region is involved with atopic dermatitis. The area represented by the palmar surface of the subject's hand with all five digits adducted together, is approximately 1% of the subject's BSA, regardless of the subject's age. BSA in handprints across 4 body regions assessed as part of the EASI assessment.
12. Change from baseline response based on more than 50% improvement in Scoring Atopic Dermatitis (SCORAD50). [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 (end of treatment/early termination), Week 16 (end of study). ]
    SCORAD is a validated scoring index for AD, which combines A: extent (0-100), B: severity (0-18), and C: subjective symptoms (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).
13. Change from baseline response based on more than 75% improvement in Scoring Atopic Dermatitis (SCORAD75). [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 (end of treatment/early termination), Week 16 (end of study). ]
    SCORAD is a validated scoring index for AD, which combines A: extent (0-100), B: severity (0-18), and C: subjective symptoms (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).
14. Change from baseline in SCORAD subjective assessments of itch and sleep loss. [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 (end of treatment/early termination), Week 16 (end of study). ]
    SCORAD is a validated scoring index for AD, which combines A: extent (0-100), B: severity (0-18), and C: subjective symptoms (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). Only the subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10), will be assessed.
15. Change from baseline in Children's Dermatology Life Quality Index (CDLQI) [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 (end of treatment/early termination), Week 16 (end of study). ]
    The CDLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question is evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
16. Change from baseline in the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 (end of treatment/early termination), Week 16 (end of study). ]
    HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
17. Change from baseline in Patient Oriented Eczema Measure (POEM) [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 (end of treatment/early termination), Week 16 (end of study). ]
    The POEM is a validated 7 item PRO measure used to assess the impact of AD recalled over the past week. It contains 7 symptom based questions with responses rating number of days each symptom was experienced over the past week, ranging from 0 (no days) to 4 (every day), with a maximum score of 28.
18. Change from baseline in Dermatitis Family Impact (DFI) questionnaire [ Time Frame: Day 1 (Baseline), Week 12 (end of treatment/early termination). ]
    The DFI is a 10-item disease questionnaire that measures the impact of having a child with AD on family quality of life. It is completed by parent/legal guardian of the child (affected by AD), based on recall over the past week. Each question is scored on a 4-point scale ranging from 0 (good) to 3 (worst), where higher scores indicated worst quality of life of family. The DFI total score is the sum of individual scores of the 10 questions and ranges from 0 (good) to 30 (worst), where higher DFI scores indicated worst quality of life of family.
19. Change from baseline of Patient Global Assessment (PtGA) [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 (end of treatment/early termination), Week 16 (end of study). ]
    The PtGA asks 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 Investigator's Global Assessment will be used for the Patient Global Assessment, ie, "severe (4)", "moderate (3)", "mild (2)", "almost clear (1)", and "clear (0)".
20. Change from baseline of EuroQol Quality of Life 5 Dimension Youth Scale (EQ-5D-Y) [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 (end of treatment/early termination), Week 16 (end of study). ]
    The EQ-5D-Y 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 (HTA). The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths age 12 through 17 years. Components assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale ranged from 1 (minimum) to 3 (maximum). Higher scores indicated worse health condition.
21. Change from baseline of Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds FACIT-F) [ Time Frame: Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 (end of treatment/early termination), Week 16 (end of study). ]
    FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). 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-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
22. Incidence of treatment emergent adverse events [ Time Frame: From Screening through Week 16 (entire study) ]

    Incidence of treatment emergent AEs. An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild (AEs does not interfere with participant's usual function); b) moderate (AEs interferes to some extent with participant's usual function) and c) severe (AEs interferes significantly with participant's usual function).

    AE's includes local tolerability, discontinuations and clinically significant changes in vital signs and clinical laboratory parameters. The investigator is to record all directly observed AE's and all AE's spontaneously reported by the subject (or subject's legal guardian). In addition, each study subject (or subject's legal guardian) will be questioned about the occurrence of AE's in a non-leading manner.

23. Incidence of Serious Adverse Events (SAE's) [ Time Frame: From Screening through Week 16 (entire study) ]
    Incidence of SAEs, eg. an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
24. Incidence of AEs leading to discontinuation; [ Time Frame: From Screening through Week 16 (entire study) ]
    Counts of participants who had adverse events leading to discontinuation.
25. The incidence of clinical abnormalities and change from baseline in clinical laboratory values, ECG measurements, and vital signs. [ Time Frame: From Screening through Week 16 (entire study) ]
    Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). A 12-lead ECG was obtained after the participant had rested quietly for at least 10 minutes. Vital signs (pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance was determined at the investigator's discretion.
26. Mean fold increase from baseline in concentrations of immunoglobulin G (IgG) against tetanus, diphtheria, and acellular pertussis combination vaccine (Tdap) [ Time Frame: Week 8 (sub-study baseline), Week 12 (end of treatment). ]

    Mean fold increase will be assessed from baseline (week 8) at 4 weeks post-vaccination in concentrations of IgG against:

    • Tetanus toxoid;
    • Diphtheria toxoid;
    • Pertussis toxoid;
    • Pertactin (PRN);
    • Filamentous hemagglutinin (FHA);
    • Fimbriae types 2 and 3 (FIM).
27. Plasma concentrations of PF 04965842 in adolescent participants 12 to <18 years of age with moderate to severe AD. [ Time Frame: Week 8, Week 12 (end of treatment). ]
    Plasma concentrations of PF-04965842 2 hours prior to dosing on Day 57 (week 8) and 2 hours post-dosing on Day 85 (Week 12)

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, United States, 35244

United States, California

Madera Family Medical Group

Madera, California, United States, 93637

Allergy & Asthma Associates of Southern California dba Southern California Research

Mission Viejo, California, United States, 92691

UC Davis

Sacramento, California, United States, 95816

United States, Florida

Moonshine Research Center, Inc.

Doral, Florida, United States, 33166

Clinical Trials Solutions

Hialeah, Florida, United States, 33012

Homestead Research Institute

Homestead, Florida, United States, 33030

Olympian Clinical Research

Largo, Florida, United States, 33770

Global Health Clinical Trials Corp

Miami, Florida, United States, 33135

La Salud Research Clinic, Inc.

Miami, Florida, United States, 33155

Nicklaus Children's Hospital

Miami, Florida, United States, 33155

South Miami Medical & Research Group, Inc.

Miami, Florida, United States, 33155

Ciocca Dermatology, PA

Miami, Florida, United States, 33173

INTERMED Medical Research Center, Inc

Miami, Florida, United States, 33175

Suncoast Research Associates

Miami, Florida, United States, 33184

AdventHealth Orlando

Orlando, Florida, United States, 32803

AdventHealth Pediatric Dermatology Orlando

Orlando, Florida, United States, 32803

AdventHealth Orlando - Investigational Drug Services

Orlando, Florida, United States, 32804

Outpatient Service Center-AdventHealth Orlando

Orlando, Florida, United States, 32804

Pediatric Outpatient Procedures and Sedation

Orlando, Florida, United States, 32804

NeuroSkeletal Imaging

Orlando, Florida, United States, 32806

Accel Research Sites - Pure Skin Dermatology & Aesthetics

Orlando, Florida, United States, 32819

Accel Research Sites - Nona Pediatric Center

Orlando, Florida, United States, 32829

ForCare Clinical Research

Tampa, Florida, United States, 33613

United States, Georgia

Columbus Regional Research Institute

Columbus, Georgia, United States, 31904

Meridian Clinical Research, LLC

Savannah, Georgia, United States, 31406

United States, Illinois

Midwest Allergy Sinus Asthma, SC

Normal, Illinois, United States, 61761

NorthShore University HealthSystem Dermatology Clinical Trials Unit

Skokie, Illinois, United States, 60077

United States, Indiana

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States, 46250

The South Bend Clinic Center for Research

South Bend, Indiana, United States, 46617

United States, Kentucky

Forefront Dermatology S.C.

Louisville, Kentucky, United States, 40202

United States, Maryland

Institute for Asthma and Allergy

Chevy Chase, Maryland, United States, 20815

DermAssociates, LLC

Rockville, Maryland, United States, 20850

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, United States, 21162

United States, Michigan

Clarkston Skin Research

Clarkston, Michigan, United States, 48346

Wayne State University / Integrative Biosciences Center

Detroit, Michigan, United States, 48202

United States, Missouri

Center for Outpatient Health

Saint Louis, Missouri, United States, 63108

St. Louis Children's Hospital

Saint Louis, Missouri, United States, 63108

St. Louis Children's Hospital

Saint Louis, Missouri, United States, 63110

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

United States, Nevada

Clinical Research Consortium

Las Vegas, Nevada, United States, 89119

United States, New York

DermResearch Center of New York, Inc.

Stony Brook, New York, United States, 11790

United States, Ohio

Synexus Clinical Research US, Inc.

Cincinnati, Ohio, United States, 45236

United States, Oklahoma

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States, 73104

United States, South Carolina

Synexus Clinical Research US, Inc.

Anderson, South Carolina, United States, 29621

Synexus Clinical Research US, Inc.

Greer, South Carolina, United States, 29651

United States, Texas

Austin Institute for Clinical Research, Inc.

Austin, Texas, United States, 78705

Center for Clinical Studies, LTD.LLP

Webster, Texas, United States, 77598

United States, Virginia

Virginia Clinical Research, Inc

Norfolk, Virginia, United States, 23502

United States, West Virginia

West Virginia Research Institute

Morgantown, West Virginia, United States, 26505

United States, Wisconsin

Children's Hospital of Wisconsin Investigational Drug Service

Milwaukee, Wisconsin, United States, 53226

Children's Hospital of Wisconsin Translational Research Unit

Milwaukee, Wisconsin, United States, 53226

Australia, New South Wales

Australian Clinical Research Network

Maroubra, New South Wales, Australia, 2035

The Skin Hospital

Westmead, New South Wales, Australia, 2145

Australia, Queensland

The Skin Centre

Benowa, Queensland, Australia, 4217

Australia, Victoria (vic)

Sinclair Dermatology

East Melbourne, Victoria (vic), Australia, 3002

Australia, Victoria

The Royal Children's Hospital

Parkville, Victoria, Australia, 3052

China, Fujian

The First Affiliated Hospital of Fujian Medical University, Dermatology Department

Fuzhou, Fujian, China, 350005

China, Hunan

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China, 410013

China, Jiangxi

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, China, 330000

China, Shandong

Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin

Jinan, Shandong, China, 250022

China, Shanghai

Huashan Hospital Fudan University

Shanghai, Shanghai, China, 200040

China, Yunnan

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China, 650032

China, Zhejiang

Hangzhou Third Hospital

Hangzhou, Zhejiang, China, 310009

The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept

Hangzhou, Zhejiang, China, 310009

China

Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology

Shanghai, China, 200092

Shanghai Dermatology Hospital

Shanghai, China, 200443

Czechia

Lekarna Na Vaclavskem namesti

Kutna Hora, Czechia, 284 01

Kozni ambulance Kutna Hora, s.r.o

Kutna Hora, Czechia, 28401

Dermamedica S.R.O.

Nachod, Czechia, 547 01

Oblastni nemocnice Nachod

Nachod, Czechia, 547 01

Lekarna u Stribrneho orla

Nachod, Czechia, 54701

Lekarna Cisarska

Praha 2, Czechia, 120 00

Synexus Czech S.R.O.

Praha 2, Czechia, 120 00

Mestska poliklinika Praha

Praha, Czechia, 110 00

Dermatovenerologicka ambulance

Svitavy, Czechia, 56802

Lekarna na Hranicni

Svitavy, Czechia, 56802

Nemocnice Svitavy

Svitavy, Czechia, 56825

Germany

Universitaetsklinikum Bonn

Bonn, NRW, Germany, 53105

Fachklinik Bad Bentheim Thermalsole- und Schwefelbad Bentheim GmbH

Bad Bentheim, Germany, 48455

Universitaetsklinikum Bonn

Bonn, Germany, 53127

MENSINGDERMA research GmbH

Hamburg, Germany, 22391

Uniklinik Muenster

Muenster, Germany, 48149

Hungary

Clinexpert Kft.

Budapest, Hungary, 1033

Bugát Pál Kórház, Bőrgyógyászati Szakrendelés

Gyöngyös, Hungary, 3200

Trial Pharma Kft.

Győr, Hungary, 9026

Trial Pharma Kft.

Kaposvár, Hungary, 7400

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Gyermek Gasztroenterológia II. emelet

Miskolc, Hungary, 3526

Trial Pharma Kft.

Püspökladány, Hungary, 4150

Italy

Istituto Clinico Humanitas IRCSS - UOC di Dermatologia

Milano, Italy, 20089

Japan

Takagi Dermatological Clinic

Obihiro, Hokkaido, Japan, 080-0013

Dermatology Shimizu Clinic

Kobe, Hyogo, Japan, 657-0846

Noguchi Dermatology Clinic

Kamimashiki-gun, Kumamoto, Japan, 861-3101

Yoshioka Dermatology Clinic

Neyagawa, Osaka, Japan, 572-0838

Kume Clinic

Sakai, Osaka, Japan, 593-8324

Fukuwa Clinic

Chuo-ku, Tokyo, Japan, 104-0031

Hoshikuma Dermatology・Allergy Clinic

Fukuoka, Japan, 814-0171

Matsuda Tomoko Dermatological Clinic

Fukuoka, Japan, 819-0167

Latvia

Aesthetic dermatology clinic of Prof. J. Kisis

Riga, Latvia, LV-1003

Outpatient Clinic Of Ventspils

Ventspils, Latvia, LV-3601

Mexico

Hospital Infantil de México Federico Gómez

Del. Cuauhtemoc, Ciudad DE Mexico, Mexico, 06720

Hospital de Jesus, I.A.P.

Del. Cuauhtémoc, Ciudad DE Mexico, Mexico, 06090

Trials in Medicine S.C.

Cuauhtemoc, Ciudad DE México, Mexico, 06700

Clinical Research Institute Saltillo S.A. de C.V.

Saltillo, Coahuila, Mexico, 25020

Unidad de Atención Médica e Investigación en Salud

Merida, Yucatan, Mexico, 97000

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

Merida, Yucatan, Mexico, 97130

Servicios Hospitalarios de Mexico S.A. de C.V. (Hospital Ángeles Chihuahua)

Chihuahua, Mexico, 31238

Sociedad de Metabolismo y Corazón S.C.

Veracruz, Mexico, 91900

Poland

KLIMED Marek Klimkiewicz

Bialystok, Poland, 15-704

Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny i Alergologiczny

Bydgoszcz, Poland, 85-650

Centrum Medyczne SENSEMED

Chorzow, Poland, 41-500

Centrum Medyczne Pratia Czestochowa

Czestochowa, Poland, 42-200

Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna "A-DERM-SERWIS"

Czestochowa, Poland, 42-217

Neutrum Lekarze M. Hlebowicz i Partnerzy Spolka Partnerska

Gdansk, Poland, 80-462

MULTIKLINIKA Salute Sp. z o.o.

Katowice, Poland, 40-123

Centrum Medyczne Angelius Provita

Katowice, Poland, 40-611

Centrum medyczne PLEJADY

Krakow, Poland, 30-363

Krakowskie Centrum Medyczne

Krakow, Poland, 31-501

Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak

Lodz, Poland, 90-436

Dermedic Jacek Zdybski

Ostrowiec Swietokrzyski, Poland, 27-400

Irmed

Piotrkow Trybunalski, Poland, 97-300

Synexus Polska Sp. z o.o. Oddzial w Poznaniu

Poznan, Poland, 60-702

Synexus Polska Sp. z o.o. Oddzial w Warszawie

Warszawa, Poland, 01-192

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

Wroclaw, Poland, 50-381

Spain

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, LAS Palmas, Spain, 35010

Hospital General Universitario de Alicante

Alicante, Spain, 03010

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain, 08041

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Hospital Universitario La Paz

Madrid, Spain, 28046

Consultas Externas Dermatologia Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

Servicio de Radiologia Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan, 402

National Taiwan University Hospital

Taipei, Taiwan, 100

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

United Kingdom

Barnsley Hospital NHS Foundation Trust

Barnsley, South Yorkshire, United Kingdom, S75 2EP

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03796676
• Other Study ID Numbers: B7451036; JADE TEEN ( Other Identifier: Alias Study Number ); 2018-003804-37 ( EudraCT Number )
• First Posted: January 8, 2019
• Last Update Posted: August 12, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

Atopic Dermatitis, JAK1 inhibitor

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases