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

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ClinicalTrials.gov Identifier: NCT03796676
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 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
Estimated Primary Completion Date : April 9, 2020
Estimated Study Completion Date : April 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796676


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Locations
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United States, Alabama
Clinical Research Center of Alabama, LLC Recruiting
Birmingham, Alabama, United States, 35244
United States, California
Center for Dermatology Clinical Research, Inc. Recruiting
Fremont, California, United States, 94538
Madera Family Medical Group Recruiting
Madera, California, United States, 93637
Allergy & Asthma Associates of Southern California dba Southern California Research Recruiting
Mission Viejo, California, United States, 92691
Choc Psf, Amc Not yet recruiting
Orange, California, United States, 92868
UC Davis Not yet recruiting
Sacramento, California, United States, 95816
Synexus Clinical Research US, Inc. Not yet recruiting
Santa Rosa, California, United States, 95405
United States, Florida
Brandon Premier Health Care/Gulf Coast Research Group, LLC Not yet recruiting
Brandon, Florida, United States, 33510
Florida Academic Centers Research and Education, LLC Recruiting
Coral Gables, Florida, United States, 33134
Moonshine Research Center, Inc. Recruiting
Doral, Florida, United States, 33166
Power MD Clinical Research Institute Recruiting
Hialeah, Florida, United States, 33012
Olympian Clinical Research Recruiting
Largo, Florida, United States, 33770
La Salud Research Clinic, Inc. Recruiting
Miami, Florida, United States, 33155
South Miami Medical & Research Group, Inc. Recruiting
Miami, Florida, United States, 33155
Ciocca Dermatology, PA Recruiting
Miami, Florida, United States, 33173
Suncoast Research Associates Recruiting
Miami, Florida, United States, 33184
AdventHealth Orlando Not yet recruiting
Orlando, Florida, United States, 32803
AdventHealth Pediatric Dermatology Orlando Not yet recruiting
Orlando, Florida, United States, 32803
AdventHealth Orlando - Investigational Drug Services Not yet recruiting
Orlando, Florida, United States, 32804
Oupatient Service Center-AdventHealth Orlando Not yet recruiting
Orlando, Florida, United States, 32804
Pediatric Outpatient Procedures and Sedation Not yet recruiting
Orlando, Florida, United States, 32804
Clinical Associates of Orlando, LLC Recruiting
Orlando, Florida, United States, 32806
Accel Research Sites Recruiting
Orlando, Florida, United States, 32819
Accel Research Sites - Nona Pediatric Center Recruiting
Orlando, Florida, United States, 32829
Leavitt Medical Associates of Florida d/b/a Ameriderm Research Not yet recruiting
Ormond Beach, Florida, United States, 32174
ForCare Clinical Research Recruiting
Tampa, Florida, United States, 33613
United States, Georgia
Columbus Regional Research Institute Recruiting
Columbus, Georgia, United States, 31904
Meridian Clinical Research, LLC Recruiting
Savannah, Georgia, United States, 31406
United States, Idaho
Advanced Clinical Research @ Treasure Valley Dermatology & Skin Cancer Center Recruiting
Boise, Idaho, United States, 83713
United States, Illinois
Christie Clinic, LLC Not yet recruiting
Champaign, Illinois, United States, 61820
Midwest Allergy Sinus Asthma, SC Recruiting
Normal, Illinois, United States, 61761
NorthShore University HealthSystem Dermatology Clinical Trials Unit Not yet recruiting
Skokie, Illinois, United States, 60077
Southern Illinois University School of Medicine Not yet recruiting
Springfield, Illinois, United States, 62702
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC Recruiting
Indianapolis, Indiana, United States, 46250
The South Bend Clinic Center for Research Recruiting
South Bend, Indiana, United States, 46617
United States, Kentucky
Forefront Dermatology S.C. Recruiting
Louisville, Kentucky, United States, 40202
United States, Maryland
Institute for Asthma and Allergy Recruiting
Chevy Chase, Maryland, United States, 20815
DermAssociates, LLC Recruiting
Rockville, Maryland, United States, 20850
Chesapeake Clinical Research, Inc. Recruiting
White Marsh, Maryland, United States, 21162
United States, Michigan
Clarkston Skin Research Recruiting
Clarkston, Michigan, United States, 48346
United States, Nebraska
Advanced Dermatology of the Midlands Recruiting
Omaha, Nebraska, United States, 68144
United States, Nevada
Clinical Research Consortium Not yet recruiting
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Skin Laser and Surgery Specialists of New York & New Jersey Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
DermResearch Center of New York, Inc. Recruiting
Stony Brook, New York, United States, 11790
United States, Ohio
Synexus Clinical Research US, Inc. Not yet recruiting
Cincinnati, Ohio, United States, 45236
United States, Rhode Island
Rhode Island Hospital Not yet recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Synexus Clinical Research US, Inc. Recruiting
Anderson, South Carolina, United States, 29621
Synexus Clinical Research US, Inc. Recruiting
Greer, South Carolina, United States, 29651
United States, Texas
Austin Institute for Clinical Research, Inc. Recruiting
Austin, Texas, United States, 78705
Stephen Miller, MD, PA Not yet recruiting
San Antonio, Texas, United States, 78249
Center for Clinical Studies, LTD.LLP Recruiting
Webster, Texas, United States, 77598
United States, Virginia
Virginia Clinical Research, Inc Recruiting
Norfolk, Virginia, United States, 23502
United States, West Virginia
West Virginia Research Institute Recruiting
Morgantown, West Virginia, United States, 26505
United States, Wisconsin
Children's Hospital of Wisconsin Investigational Drug Service Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Children's Hospital of Wisconsin Translational Research Unit Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Australian Clinical Research Network Not yet recruiting
Maroubra, New South Wales, Australia, 2035
The Skin Hospital (Skin & Cancer Foundation Australia) Recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
The Skin Centre Not yet recruiting
Benowa, Queensland, Australia, 4217
Veracity Clinical Research Pty Ltd Not yet recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria (vic)
Sinclair Dermatology Recruiting
East Melbourne, Victoria (vic), Australia, 3002
Australia, Victoria
The Royal Children's Hospital Not yet recruiting
Parkville, Victoria, Australia, 3052
China, Hunan
The Third Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China, 410013
China, Jiangxi
Dermatology Hospital of Jiangxi Province Recruiting
Nanchang, Jiangxi, China, 330000
China, Shandong
Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin Recruiting
Jinan, Shandong, China, 250022
China, Zhejiang
Hangzhou Third Hospital Not yet recruiting
Hangzhou, Zhejiang, China, 310009
China
Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology Recruiting
Shanghai, China, 200092
Shanghai Dermatology Hospital Recruiting
Shanghai, China, 200443
Czechia
Lekarna Na Vaclavskem namesti Not yet recruiting
Kutna Hora, Czechia, 284 01
Kozni ambulance Kutna Hora, s.r.o Not yet recruiting
Kutna Hora, Czechia, 28401
Dermamedica S.R.O. Not yet recruiting
Nachod, Czechia, 547 01
Lekarna U Stribrneho orla (pharmacy) Not yet recruiting
Nachod, Czechia, 547 01
Oblastni nemocnice Nachod (x-ray) Not yet recruiting
Nachod, Czechia, 547 01
Fakultni nemocnice Kralovske Vinohrady Not yet recruiting
Praha 10, Czechia, 100 34
Sanatorium profesora Arenbergera Not yet recruiting
Praha 1, Czechia, 11000
Lekarna Cisarska (Pharmacy) Not yet recruiting
Praha 2, Czechia, 120 00
Lekarna U sv. Ignace Not yet recruiting
Praha 2, Czechia, 120 00
Synexus Czech S.R.O. Not yet recruiting
Praha 2, Czechia, 120 00
Mestska poliklinika Praha (x-ray) Not yet recruiting
Praha, Czechia, 110 00
Dermatologicka Ambulance Not yet recruiting
Svitavy, Czechia, 568 02
Lekarna na Hranicni (Pharmacy) Not yet recruiting
Svitavy, Czechia, 56802
Nemocnice Svitavy (x-ray) Not yet recruiting
Svitavy, Czechia, 56825
Hungary
Clinexpert Kft. Not yet recruiting
Budapest, Hungary, 1033
Bugát Pál Kórház, Bőrgyógyászati Szakrendelés Recruiting
Gyöngyös, Hungary, 3200
Trial Pharma Kft. Recruiting
Püspökladány, Hungary, 4150
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Not yet recruiting
Szeged, Hungary, 6720
MEDIPARS Kft. Not yet recruiting
Szekszárd, Hungary, 7100
Italy
Istituto Clinico Humanitas IRCSS - UOC di Dermatologia Not yet recruiting
Milano, Italy, 20089
Japan
Takagi Dermatological Clinic Recruiting
Obihiro, Hokkaido, Japan, 080-0013
Dermatology Shimizu Clinic Recruiting
Kobe, Hyogo, Japan, 657-0846
Noguchi Dermatology Clinic Recruiting
Kamimashiki-gun, Kumamoto, Japan, 861-3101
Yoshioka Dermatology Clinic Recruiting
Neyagawa, Osaka, Japan, 572-0838
Kume Clinic Recruiting
Sakai, Osaka, Japan, 593-8324
Fukuwa Clinic Recruiting
Chuo-ku, Tokyo, Japan, 103-0027
Hoshikuma Dermatology・Allergy Clinic Recruiting
Fukuoka, Japan, 814-0171
Matsuda Tomoko Dermatological Clinic Recruiting
Fukuoka, Japan, 819-0167
Latvia
Aesthetic dermatology clinic of Prof. J. Kisis Not yet recruiting
Riga, Latvia, LV-1003
Outpatient Clinic Of Ventspils Not yet recruiting
Ventspils, Latvia, LV-3601
Poland
KLIMED Marek Klimkiewicz Not yet recruiting
Bialystok, Poland, 15-704
Neutrum Lekarze M. Hlebowicz i Partnerzy Spolka Partnerska Not yet recruiting
Gdansk, Poland, 80-462
Krakowskie Centrum Medyczne Not yet recruiting
Krakow, Poland, 31-501
Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak Not yet recruiting
Lodz, Poland, 90-436
Dermedic Jacek Zdybski Not yet recruiting
Ostrowiec Swietokrzyski, Poland, 27-400
Synexus Polska Sp. z o.o. Oddzial w Poznaniu Not yet recruiting
Poznan, Poland, 60-702
Synexus Polska Sp. z o.o. Oddzial w Warszawie Not yet recruiting
Warszawa, Poland, 01-192
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu Not yet recruiting
Wroclaw, Poland, 50-381
Spain
Hospital Universitario de Gran Canaria Dr. Negrin Not yet recruiting
Las Palmas de Gran Canaria, LAS Palmas, Spain, 35010
Hospital General Universitario de Alicante Not yet recruiting
Alicante, Spain, 03010
Hospital de la Santa Creu i Sant Pau Not yet recruiting
Barcelona, Spain, 08041
Hospital del Nino Jesus Not yet recruiting
Madrid, Spain, 28009
Hospital Universitario 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain, 28046
Hospital Universitario Miguel Servet Consultas Externas Dermatología Not yet recruiting
Zaragoza, Spain, 50009
Hospital Universitario Miguel Servet Not yet recruiting
Zaragoza, Spain, 50009
Taiwan
Chung Shan Medical University Hospital Not yet recruiting
Taichung City, South DIST, Taiwan, 402
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03796676     History of Changes
Other Study ID Numbers: B7451036
JADE TEEN ( Other Identifier: Alias Study Number )
2018-003804-37 ( EudraCT Number )
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
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

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