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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03796676




Registration number
NCT03796676
Ethics application status
Date submitted
4/01/2019
Date registered
8/01/2019

Titles & IDs
Public title
JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis
Scientific 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
Secondary ID [1] 0 0
JADE TEEN
Secondary ID [2] 0 0
B7451036
Universal Trial Number (UTN)
Trial acronym
JADE TEEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - PF-04965842
Treatment: Drugs - PF04965842

Placebo comparator: Placebo - Placebo

Experimental: PF-04965842 100 mg QD - active

Experimental: PF-04965842 200 mg QD - active


Treatment: Drugs: Placebo
Placebo

Treatment: Drugs: PF-04965842
100 mg QD

Treatment: Drugs: PF04965842
200 mg QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline to Week 12
Primary outcome [2] 0 0
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response = 75% Improvement From Baseline at Week 12
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline, Weeks 2, 4 and 12
Secondary outcome [2] 0 0
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline, Weeks 2, 4 and 8
Secondary outcome [4] 0 0
Percentage of Participants Achieving EASI Response = 75% Improvement From Baseline at All Scheduled Time Points Except Week 12
Timepoint [4] 0 0
Baseline, Weeks 2, 4 and 8
Secondary outcome [5] 0 0
Percentage of Participants Achieving EASI Response = 50% Improvement From Baseline
Timepoint [5] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [6] 0 0
Percentage of Participants Achieving EASI Response = 90% Improvement From Baseline
Timepoint [6] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [7] 0 0
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline
Timepoint [7] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [8] 0 0
Percent Change From Baseline in EASI Score
Timepoint [8] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Secondary outcome [10] 0 0
Time to First Achieve =4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus
Timepoint [10] 0 0
Baseline to Week 16
Secondary outcome [11] 0 0
Percent Change From Baseline in PP-NRS for Severity of Pruritus
Timepoint [11] 0 0
Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Secondary outcome [12] 0 0
Change From Baseline in Percentage Body Surface Area (BSA)
Timepoint [12] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [13] 0 0
Percent Change From Baseline in Percentage BSA
Timepoint [13] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [14] 0 0
Percentage of Participants Achieving Percentage BSA < 5% at Week 12
Timepoint [14] 0 0
Baseline to Week 12
Secondary outcome [15] 0 0
Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response = 50% Improvement From Baseline
Timepoint [15] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [16] 0 0
Percentage of Participants Achieving SCORAD Response = 75% Improvement From Baseline
Timepoint [16] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [17] 0 0
Change From Baseline in SCORAD Total Score
Timepoint [17] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [18] 0 0
Percent Change From Baseline in SCORAD Total Score
Timepoint [18] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [19] 0 0
Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss
Timepoint [19] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [20] 0 0
Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss
Timepoint [20] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [21] 0 0
Number of Days When a Corticosteroid Not Used up to Day 88
Timepoint [21] 0 0
Baseline to Day 88
Secondary outcome [22] 0 0
Change From Baseline in Children's Dermatology Life Quality Index (DLQI)
Timepoint [22] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [23] 0 0
Percentage of Participants With =2.5 Points at Baseline and Achieving =2.5 Points Improvement From Baseline in Children's DLQI
Timepoint [23] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [24] 0 0
Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS)
Timepoint [24] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [25] 0 0
Change From Baseline in Depression of HADS
Timepoint [25] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [26] 0 0
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
Timepoint [26] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [27] 0 0
Change From Baseline in Dermatitis Family Impact (DFI) at Week 12
Timepoint [27] 0 0
Baseline to Week 12
Secondary outcome [28] 0 0
Change From Baseline in Patient Global Assessment (PtGA)
Timepoint [28] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [29] 0 0
Percentage of Participants With =2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and =2 Points Improvement From Baseline in PtGA
Timepoint [29] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [30] 0 0
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score
Timepoint [30] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [31] 0 0
Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12
Timepoint [31] 0 0
Baseline to Week 12
Secondary outcome [32] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [32] 0 0
16 weeks
Secondary outcome [33] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [33] 0 0
16 weeks
Secondary outcome [34] 0 0
Number of Participants Who Discontinued From the Study Due to TEAEs
Timepoint [34] 0 0
16 weeks
Secondary outcome [35] 0 0
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Timepoint [35] 0 0
16 weeks
Secondary outcome [36] 0 0
Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria
Timepoint [36] 0 0
16 weeks
Secondary outcome [37] 0 0
Categorization of Vital Signs Data Meeting Prespecified Criteria
Timepoint [37] 0 0
16 weeks
Secondary outcome [38] 0 0
Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination
Timepoint [38] 0 0
4 weeks post-vaccination with Tdap (Week 12)
Secondary outcome [39] 0 0
Plasma PF-04965842 Concentration at Week 8
Timepoint [39] 0 0
2 hours pre-dose at Week 8
Secondary outcome [40] 0 0
Plasma PF-04965842 Concentration at Week 12
Timepoint [40] 0 0
2 hours post-dose at Week 12

Eligibility
Key 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)
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
* Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
* Prior treatment with JAK inhibitors
* Other active non-AD inflammatory skin diseases or conditions affecting skin
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
* Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/04/2020
Sample size
Target
Accrual to date
Final
287
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC, (vic)VIC
Recruitment hospital [1] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [2] 0 0
The Skin Hospital - Westmead
Recruitment hospital [3] 0 0
The Skin Centre - Benowa
Recruitment hospital [4] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [5] 0 0
The Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4217 - Benowa
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
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Nevada
Country [12] 0 0
United States of America
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New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
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Oklahoma
Country [15] 0 0
United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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West Virginia
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United States of America
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Wisconsin
Country [20] 0 0
China
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Fujian
Country [21] 0 0
China
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Hunan
Country [22] 0 0
China
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Jiangxi
Country [23] 0 0
China
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Shandong
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China
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Shanghai
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China
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Yunnan
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China
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Zhejiang
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Czechia
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Kutna Hora
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Czechia
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Nachod
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Czechia
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Praha 2
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Czechia
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Praha
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Czechia
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Svitavy
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Germany
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NRW
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Germany
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Bad Bentheim
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Germany
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Bonn
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Germany
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Hamburg
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Germany
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Muenster
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Hungary
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Budapest
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Hungary
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Gyöngyös
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Hungary
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Gyor
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Hungary
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Kaposvár
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Hungary
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Miskolc
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Hungary
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Püspökladány
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Italy
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Milano
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Hokkaido
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Japan
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Hyogo
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Kumamoto
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Osaka
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Tokyo
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Japan
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Fukuoka
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Riga
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Ventspils
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Mexico
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Ciudad DE Mexico
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Mexico
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Ciudad DE México
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Coahuila
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Mexico
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Veracruz
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Poland
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Bialystok
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Bydgoszcz
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Chorzow
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Czestochowa
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Gdansk
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Ostrowiec Swietokrzyski
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Poland
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Piotrkow Trybunalski
Country [68] 0 0
Poland
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Poznan
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Poland
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Warszawa
Country [70] 0 0
Poland
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Wroclaw
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Spain
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LAS Palmas
Country [72] 0 0
Spain
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Alicante
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Zaragoza
Country [76] 0 0
Taiwan
State/province [76] 0 0
Taichung
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taipei
Country [78] 0 0
United Kingdom
State/province [78] 0 0
South Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03796676