Back to resultsJAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis (JADE TEEN)
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
PF-04965842
PF04965842
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, JAK1 inhibitor
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
Sites / Locations
- Clinical Research Center of Alabama, LLC
- Madera Family Medical Group
- Allergy & Asthma Associates of Southern California dba Southern California Research
- UC Davis
- Moonshine Research Center, Inc.
- Homestead Research Institute
- Olympian Clinical Research
- Clinical Trials Solutions
- Global Health Clinical Trials Corp
- La Salud Research Clinic, Inc.
- Nicklaus Children's Hospital
- South Miami Medical & Research Group, Inc.
- Ciocca Dermatology, PA
- INTERMED Medical Research Center, Inc
- Suncoast Research Associates
- AdventHealth Orlando
- AdventHealth Pediatric Dermatology Orlando
- AdventHealth Orlando - Investigational Drug Services
- Outpatient Service Center-AdventHealth Orlando
- Pediatric Outpatient Procedures and Sedation
- NeuroSkeletal Imaging
- Accel Research Sites - Pure Skin Dermatology & Aesthetics
- Accel Research Sites - Nona Pediatric Center
- ForCare Clinical Research
- Columbus Regional Research Institute
- Meridian Clinical Research, LLC
- Midwest Allergy Sinus Asthma, SC
- NorthShore University HealthSystem Dermatology Clinical Trials Unit
- Dawes Fretzin Clinical Research Group, LLC
- The South Bend Clinic Center for Research
- Forefront Dermatology S.C.
- Institute for Asthma and Allergy
- DermAssociates, LLC
- Chesapeake Clinical Research, Inc.
- Clarkston Skin Research
- Wayne State University / Integrative Biosciences Center
- Center for Outpatient Health
- St. Louis Children's Hospital
- St. Louis Children's Hospital
- Washington University School of Medicine
- Clinical Research Consortium
- DermResearch Center of New York, Inc.
- Synexus Clinical Research US, Inc.
- University of Oklahoma Health Science Center
- Synexus Clinical Research US, Inc.
- Synexus Clinical Research US, Inc.
- Austin Institute for Clinical Research, Inc.
- Center for Clinical Studies, LTD.LLP
- Virginia Clinical Research, Inc
- West Virginia Research Institute
- Children's Hospital of Wisconsin Investigational Drug Service
- Children's Hospital of Wisconsin Translational Research Unit
- Australian Clinical Research Network
- The Skin Hospital
- The Skin Centre
- Sinclair Dermatology
- The Royal Children's Hospital
- The First Affiliated Hospital of Fujian Medical University, Dermatology Department
- The Third Xiangya Hospital of Central South University
- Dermatology Hospital of Jiangxi Province
- Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin
- Huashan Hospital Fudan University
- First Affiliated Hospital of Kunming Medical University
- Hangzhou Third Hospital
- The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept
- Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology
- Shanghai Dermatology Hospital
- Lekarna Na Vaclavskem namesti
- Kozni ambulance Kutna Hora, s.r.o
- Dermamedica S.R.O.
- Oblastni nemocnice Nachod
- Lekarna u Stribrneho orla
- Lekarna Cisarska
- Synexus Czech S.R.O.
- Mestska poliklinika Praha
- Dermatovenerologicka ambulance
- Lekarna na Hranicni
- Nemocnice Svitavy
- Universitaetsklinikum Bonn
- Fachklinik Bad Bentheim Thermalsole- und Schwefelbad Bentheim GmbH
- Universitaetsklinikum Bonn
- MENSINGDERMA research GmbH
- Uniklinik Muenster
- Clinexpert Kft.
- Bugát Pál Kórház, Bőrgyógyászati Szakrendelés
- Trial Pharma Kft.
- Trial Pharma Kft.
- Borsod-Abaúj-Zemplén Megyei Központi Kórház és Gyermek Gasztroenterológia II. emelet
- Trial Pharma Kft.
- Istituto Clinico Humanitas IRCSS - UOC di Dermatologia
- Takagi Dermatological Clinic
- Dermatology Shimizu Clinic
- Noguchi Dermatology Clinic
- Yoshioka Dermatology Clinic
- Kume Clinic
- Fukuwa Clinic
- Hoshikuma Dermatology・Allergy Clinic
- Matsuda Tomoko Dermatological Clinic
- Aesthetic dermatology clinic of Prof. J. Kisis
- Outpatient Clinic Of Ventspils
- Hospital Infantil de México Federico Gómez
- Hospital de Jesus, I.A.P.
- Trials in Medicine S.C.
- Clinical Research Institute Saltillo S.A. de C.V.
- Unidad de Atención Médica e Investigación en Salud
- Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
- Servicios Hospitalarios de Mexico S.A. de C.V. (Hospital Ángeles Chihuahua)
- Sociedad de Metabolismo y Corazón S.C.
- KLIMED Marek Klimkiewicz
- Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny i Alergologiczny
- Centrum Medyczne SENSEMED
- Centrum Medyczne Pratia Czestochowa
- Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna "A-DERM-SERWIS"
- Neutrum Lekarze M. Hlebowicz i Partnerzy Spolka Partnerska
- MULTIKLINIKA Salute Sp. z o.o.
- Centrum Medyczne Angelius Provita
- Centrum medyczne PLEJADY
- Krakowskie Centrum Medyczne
- Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
- Dermedic Jacek Zdybski
- Irmed
- Synexus Polska Sp. z o.o. Oddzial w Poznaniu
- Synexus Polska Sp. z o.o. Oddzial w Warszawie
- Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
- Hospital Universitario de Gran Canaria Dr. Negrin
- Hospital General Universitario de Alicante
- Hospital De La Santa Creu I Sant Pau
- Hospital Universitario 12 de Octubre
- Hospital Universitario La Paz
- Consultas Externas Dermatologia Hospital Universitario Miguel Servet
- Hospital Universitario Miguel Servet
- Servicio de Radiologia Hospital Universitario Miguel Servet
- Chung Shan Medical University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Barnsley Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
PF-04965842 100 mg QD
PF-04965842 200 mg QD
Arm Description
Placebo
active
active
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12
The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Secondary Outcome Measures
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder.
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12
The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep & Usual Activities Questions and Patient Global Impression of Severity & Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms.
Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Percent Change From Baseline in EASI Score
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder.
Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10).
Percent Change From Baseline in PP-NRS for Severity of Pruritus
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10).
Change From Baseline in Percentage Body Surface Area (BSA)
BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Percent Change From Baseline in Percentage BSA
BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Percentage of Participants Achieving Percentage BSA < 5% at Week 12
BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline
SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline
SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Change From Baseline in SCORAD Total Score
SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Percent Change From Baseline in SCORAD Total Score
SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss
SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.
Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss
SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.
Number of Days When a Corticosteroid Not Used up to Day 88
Change From Baseline in Children's Dermatology Life Quality Index (DLQI)
The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.
Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI
The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.
Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
Change From Baseline in Depression of HADS
The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD.
Change From Baseline in Dermatitis Family Impact (DFI) at Week 12
The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" or "not at all (0)". The score can range from 0 to 30. The higher values represent the worse impact.
Change From Baseline in Patient Global Assessment (PtGA)
The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.
Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA
The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score
The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine).
Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12
The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Number of Participants With Serious Adverse Events (SAEs)
A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
Number of Participants Who Discontinued From the Study Due to TEAEs
An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal.
Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria
A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to >500 ms or >60 ms change from screening ECG); data are presented below.
Categorization of Vital Signs Data Meeting Prespecified Criteria
Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes.
Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination
The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution.
Plasma PF-04965842 Concentration at Week 8
Plasma PF-04965842 Concentration at Week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03796676
Brief Title
JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis
Acronym
JADE TEEN
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
April 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, JAK1 inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
287 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
PF-04965842 100 mg QD
Arm Type
Experimental
Arm Description
active
Arm Title
PF-04965842 200 mg QD
Arm Type
Experimental
Arm Description
active
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
PF-04965842
Intervention Description
100 mg QD
Intervention Type
Drug
Intervention Name(s)
PF04965842
Intervention Description
200 mg QD
Primary Outcome Measure Information:
Title
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
Description
The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
Time Frame
Baseline to Week 12
Title
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12
Description
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
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
Description
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder.
Time Frame
Baseline, Weeks 2, 4 and 12
Title
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12
Description
The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep & Usual Activities Questions and Patient Global Impression of Severity & Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms.
Time Frame
Baseline to Week 12
Title
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
Description
The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
Time Frame
Baseline, Weeks 2, 4 and 8
Title
Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12
Description
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Time Frame
Baseline, Weeks 2, 4 and 8
Title
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline
Description
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline
Description
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline
Description
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Percent Change From Baseline in EASI Score
Description
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
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
Description
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder.
Time Frame
Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Title
Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus
Description
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10).
Time Frame
Baseline to Week 16
Title
Percent Change From Baseline in PP-NRS for Severity of Pruritus
Description
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10).
Time Frame
Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Title
Change From Baseline in Percentage Body Surface Area (BSA)
Description
BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Percent Change From Baseline in Percentage BSA
Description
BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Percentage of Participants Achieving Percentage BSA < 5% at Week 12
Description
BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Time Frame
Baseline to Week 12
Title
Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline
Description
SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline
Description
SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Change From Baseline in SCORAD Total Score
Description
SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Percent Change From Baseline in SCORAD Total Score
Description
SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss
Description
SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss
Description
SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Number of Days When a Corticosteroid Not Used up to Day 88
Time Frame
Baseline to Day 88
Title
Change From Baseline in Children's Dermatology Life Quality Index (DLQI)
Description
The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI
Description
The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS)
Description
The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Change From Baseline in Depression of HADS
Description
The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
Description
The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Change From Baseline in Dermatitis Family Impact (DFI) at Week 12
Description
The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" or "not at all (0)". The score can range from 0 to 30. The higher values represent the worse impact.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Patient Global Assessment (PtGA)
Description
The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA
Description
The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score
Description
The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine).
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12
Description
The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated.
Time Frame
Baseline to Week 12
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Time Frame
16 weeks
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
Time Frame
16 weeks
Title
Number of Participants Who Discontinued From the Study Due to TEAEs
Description
An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Time Frame
16 weeks
Title
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Description
Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal.
Time Frame
16 weeks
Title
Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria
Description
A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to >500 ms or >60 ms change from screening ECG); data are presented below.
Time Frame
16 weeks
Title
Categorization of Vital Signs Data Meeting Prespecified Criteria
Description
Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes.
Time Frame
16 weeks
Title
Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination
Description
The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution.
Time Frame
4 weeks post-vaccination with Tdap (Week 12)
Title
Plasma PF-04965842 Concentration at Week 8
Time Frame
2 hours pre-dose at Week 8
Title
Plasma PF-04965842 Concentration at Week 12
Time Frame
2 hours post-dose at Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Center of Alabama, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Madera Family Medical Group
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Allergy & Asthma Associates of Southern California dba Southern California Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Moonshine Research Center, Inc.
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Homestead Research Institute
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Olympian Clinical Research
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Clinical Trials Solutions
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Global Health Clinical Trials Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
La Salud Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
South Miami Medical & Research Group, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Ciocca Dermatology, PA
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
INTERMED Medical Research Center, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Suncoast Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
AdventHealth Pediatric Dermatology Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
AdventHealth Orlando - Investigational Drug Services
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Outpatient Service Center-AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Pediatric Outpatient Procedures and Sedation
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
NeuroSkeletal Imaging
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Accel Research Sites - Pure Skin Dermatology & Aesthetics
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Accel Research Sites - Nona Pediatric Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32829
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Midwest Allergy Sinus Asthma, SC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
NorthShore University HealthSystem Dermatology Clinical Trials Unit
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
The South Bend Clinic Center for Research
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Forefront Dermatology S.C.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Institute for Asthma and Allergy
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
DermAssociates, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Chesapeake Clinical Research, Inc.
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Facility Name
Clarkston Skin Research
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Wayne State University / Integrative Biosciences Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Center for Outpatient Health
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Clinical Research Consortium
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
DermResearch Center of New York, Inc.
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Austin Institute for Clinical Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Center for Clinical Studies, LTD.LLP
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Virginia Clinical Research, Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
West Virginia Research Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Children's Hospital of Wisconsin Investigational Drug Service
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Children's Hospital of Wisconsin Translational Research Unit
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Australian Clinical Research Network
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
The Skin Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Sinclair Dermatology
City
East Melbourne
State/Province
Victoria (vic)
ZIP/Postal Code
3002
Country
Australia
Facility Name
The Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
The First Affiliated Hospital of Fujian Medical University, Dermatology Department
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Dermatology Hospital of Jiangxi Province
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Facility Name
Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250022
Country
China
Facility Name
Huashan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
Hangzhou Third Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology
City
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Shanghai Dermatology Hospital
City
Shanghai
ZIP/Postal Code
200443
Country
China
Facility Name
Lekarna Na Vaclavskem namesti
City
Kutna Hora
ZIP/Postal Code
284 01
Country
Czechia
Facility Name
Kozni ambulance Kutna Hora, s.r.o
City
Kutna Hora
ZIP/Postal Code
28401
Country
Czechia
Facility Name
Dermamedica S.R.O.
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
Oblastni nemocnice Nachod
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
Lekarna u Stribrneho orla
City
Nachod
ZIP/Postal Code
54701
Country
Czechia
Facility Name
Lekarna Cisarska
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Synexus Czech S.R.O.
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Mestska poliklinika Praha
City
Praha
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
Dermatovenerologicka ambulance
City
Svitavy
ZIP/Postal Code
56802
Country
Czechia
Facility Name
Lekarna na Hranicni
City
Svitavy
ZIP/Postal Code
56802
Country
Czechia
Facility Name
Nemocnice Svitavy
City
Svitavy
ZIP/Postal Code
56825
Country
Czechia
Facility Name
Universitaetsklinikum Bonn
City
Bonn
State/Province
NRW
ZIP/Postal Code
53105
Country
Germany
Facility Name
Fachklinik Bad Bentheim Thermalsole- und Schwefelbad Bentheim GmbH
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Universitaetsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
MENSINGDERMA research GmbH
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Uniklinik Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Clinexpert Kft.
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Bugát Pál Kórház, Bőrgyógyászati Szakrendelés
City
Gyöngyös
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Trial Pharma Kft.
City
Győr
ZIP/Postal Code
9026
Country
Hungary
Facility Name
Trial Pharma Kft.
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Gyermek Gasztroenterológia II. emelet
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Trial Pharma Kft.
City
Püspökladány
ZIP/Postal Code
4150
Country
Hungary
Facility Name
Istituto Clinico Humanitas IRCSS - UOC di Dermatologia
City
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Takagi Dermatological Clinic
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Dermatology Shimizu Clinic
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
657-0846
Country
Japan
Facility Name
Noguchi Dermatology Clinic
City
Kamimashiki-gun
State/Province
Kumamoto
ZIP/Postal Code
861-3101
Country
Japan
Facility Name
Yoshioka Dermatology Clinic
City
Neyagawa
State/Province
Osaka
ZIP/Postal Code
572-0838
Country
Japan
Facility Name
Kume Clinic
City
Sakai
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Fukuwa Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Hoshikuma Dermatology・Allergy Clinic
City
Fukuoka
ZIP/Postal Code
814-0171
Country
Japan
Facility Name
Matsuda Tomoko Dermatological Clinic
City
Fukuoka
ZIP/Postal Code
819-0167
Country
Japan
Facility Name
Aesthetic dermatology clinic of Prof. J. Kisis
City
Riga
ZIP/Postal Code
LV-1003
Country
Latvia
Facility Name
Outpatient Clinic Of Ventspils
City
Ventspils
ZIP/Postal Code
LV-3601
Country
Latvia
Facility Name
Hospital Infantil de México Federico Gómez
City
Del. Cuauhtemoc
State/Province
Ciudad DE Mexico
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Hospital de Jesus, I.A.P.
City
Del. Cuauhtémoc
State/Province
Ciudad DE Mexico
ZIP/Postal Code
06090
Country
Mexico
Facility Name
Trials in Medicine S.C.
City
Cuauhtemoc
State/Province
Ciudad DE México
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Clinical Research Institute Saltillo S.A. de C.V.
City
Saltillo
State/Province
Coahuila
ZIP/Postal Code
25020
Country
Mexico
Facility Name
Unidad de Atención Médica e Investigación en Salud
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97130
Country
Mexico
Facility Name
Servicios Hospitalarios de Mexico S.A. de C.V. (Hospital Ángeles Chihuahua)
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
Facility Name
Sociedad de Metabolismo y Corazón S.C.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
KLIMED Marek Klimkiewicz
City
Bialystok
ZIP/Postal Code
15-704
Country
Poland
Facility Name
Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny i Alergologiczny
City
Bydgoszcz
ZIP/Postal Code
85-650
Country
Poland
Facility Name
Centrum Medyczne SENSEMED
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Centrum Medyczne Pratia Czestochowa
City
Czestochowa
ZIP/Postal Code
42-200
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna "A-DERM-SERWIS"
City
Czestochowa
ZIP/Postal Code
42-217
Country
Poland
Facility Name
Neutrum Lekarze M. Hlebowicz i Partnerzy Spolka Partnerska
City
Gdansk
ZIP/Postal Code
80-462
Country
Poland
Facility Name
MULTIKLINIKA Salute Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Centrum Medyczne Angelius Provita
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Centrum medyczne PLEJADY
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Krakowskie Centrum Medyczne
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Dermedic Jacek Zdybski
City
Ostrowiec Swietokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Irmed
City
Piotrkow Trybunalski
ZIP/Postal Code
97-300
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
City
Poznan
ZIP/Postal Code
60-702
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Warszawie
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Hospital Universitario de Gran Canaria Dr. Negrin
City
Las Palmas de Gran Canaria
State/Province
LAS Palmas
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital De La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Consultas Externas Dermatologia Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Servicio de Radiologia Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Barnsley Hospital NHS Foundation Trust
City
Barnsley
State/Province
South Yorkshire
ZIP/Postal Code
S75 2EP
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
34743361
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.
Results Reference
derived
PubMed Identifier
34406366
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. Erratum In: JAMA Dermatol. 2021 Oct 1;157(10):1246.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7451036
Description
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Learn more about this trial
JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis
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