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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03349060




Registration number
NCT03349060
Ethics application status
Date submitted
17/11/2017
Date registered
21/11/2017
Date last updated
10/12/2019

Titles & IDs
Public title
Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
Scientific title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04965842 MONOTHERAPY IN SUBJECTS AGED 12 YEARS AND OLDER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Secondary ID [1] 0 0
2017-003651-29
Secondary ID [2] 0 0
B7451012
Universal Trial Number (UTN)
Trial acronym
JADE Mono-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatitis, Atopic 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 - PF-04965842 100 mg
Treatment: Drugs - PF-04965842 200 mg
Treatment: Drugs - Placebo

Experimental: PF-04965842 100 mg -

Experimental: PF-04965842 200 mg -

Placebo Comparator: Placebo -


Treatment: Drugs: PF-04965842 100 mg
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks

Treatment: Drugs: PF-04965842 200 mg
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks

Treatment: Drugs: Placebo
Placebo, administered as two tablets to be taken orally once daily for 12 weeks
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 Greater Than or Equal to 2 Points Improvement From Baseline at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Primary outcome [2] 0 0
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 12
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Week 2, 4, 8 and 12: Full Analysis Set (FAS)
Timepoint [1] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [2] 0 0
Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale for Severity of Pruritus at Week 2, 4 and 12: Per Protocol Analysis Set (PPAS)
Timepoint [2] 0 0
Baseline, Week 2, 4, 12
Secondary outcome [3] 0 0
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set
Timepoint [3] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [4] 0 0
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus
Timepoint [5] 0 0
Baseline up to Week 12
Secondary outcome [6] 0 0
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8
Timepoint [6] 0 0
Baseline, Week 2, 4, 8
Secondary outcome [7] 0 0
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 2, 4 and 8
Timepoint [7] 0 0
Baseline, Week 2, 4, 8
Secondary outcome [8] 0 0
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12
Timepoint [8] 0 0
Week 2, 4, 8, 12
Secondary outcome [9] 0 0
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12
Timepoint [9] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [10] 0 0
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12
Timepoint [10] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [11] 0 0
Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12
Timepoint [11] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [12] 0 0
Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12
Timepoint [12] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [13] 0 0
Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12
Timepoint [13] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [14] 0 0
Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12
Timepoint [14] 0 0
Week 2, 4, 8, 12
Secondary outcome [15] 0 0
Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12
Timepoint [15] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [16] 0 0
Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12
Timepoint [16] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [17] 0 0
Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12
Timepoint [17] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [18] 0 0
Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12
Timepoint [18] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [19] 0 0
Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12
Timepoint [19] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [20] 0 0
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12
Timepoint [20] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [21] 0 0
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12
Timepoint [21] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [22] 0 0
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12
Timepoint [22] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [23] 0 0
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12
Timepoint [23] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [24] 0 0
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=4 and Achieving >=4 Point Improvement From Baseline in DLQI Score at Week 2, 4, 8 and 12
Timepoint [24] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [25] 0 0
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2.5 and Achieving >=2.5 Point Improvement From Baseline in CDLQI Score at Week 2, 4, 8 and 12
Timepoint [25] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [26] 0 0
Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12
Timepoint [26] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [27] 0 0
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12
Timepoint [27] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [28] 0 0
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12
Timepoint [28] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [29] 0 0
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12
Timepoint [29] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [30] 0 0
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12
Timepoint [30] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [31] 0 0
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12
Timepoint [31] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [32] 0 0
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12
Timepoint [32] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [33] 0 0
Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12
Timepoint [33] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [34] 0 0
Percentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12
Timepoint [34] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [35] 0 0
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12
Timepoint [35] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [36] 0 0
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)- Visual Analogue Scale Score at Week 2, 4, 8 and 12
Timepoint [36] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [37] 0 0
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12
Timepoint [37] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [38] 0 0
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12
Timepoint [38] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [39] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12
Timepoint [39] 0 0
Baseline, Week 12
Secondary outcome [40] 0 0
Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12
Timepoint [40] 0 0
Baseline, Week 12
Secondary outcome [41] 0 0
Change From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary
Timepoint [41] 0 0
Baseline, Week 12
Secondary outcome [42] 0 0
Change From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary
Timepoint [42] 0 0
Baseline, Week 12
Secondary outcome [43] 0 0
Plasma Concentration Versus Time Summary of PF-04965842
Timepoint [43] 0 0
Day 1 of Week 4: 0 hour(Pre-dose), 0.5 hours post-dose; Day 1 of Week 12: 0.5, 4 hours post-dose

Eligibility
Key inclusion criteria
- 12 years of age or older 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 4)

- Recent history of inadequate response or inability to tolerate topical AD treatments
or require systemic treatments for AD control
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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 nonAD inflammatory skin diseases or conditions affecting skin

- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q
wave interval abnormalities, current or history of certain infections, cancer,
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
7/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/03/2019
Sample size
Target
Accrual to date
Final
387
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Australian Clinical Research Network (ACRN) - Maroubra
Recruitment hospital [2] 0 0
Spectrum Medical Imaging - Maroubra
Recruitment hospital [3] 0 0
Queensland X-Ray - Upper Mount Gravatt
Recruitment hospital [4] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [5] 0 0
Emeritus Research - Camberwell
Recruitment hospital [6] 0 0
Skin and Cancer Foundation Inc - Carlton
Recruitment hospital [7] 0 0
Melbourne Radiology Clinic - East Melbourne
Recruitment hospital [8] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [9] 0 0
The Royal Children's Hospital - Parkville
Recruitment hospital [10] 0 0
Bridge Road Imaging - Richmond
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
4122 - Upper Mount Gravatt
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment postcode(s) [8] 0 0
3121 - Richmond
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
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
Manitoba
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Czechia
State/province [21] 0 0
Kutna Hora
Country [22] 0 0
Czechia
State/province [22] 0 0
Ostrava - Poruba
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha 1
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha 2
Country [25] 0 0
Czechia
State/province [25] 0 0
Usti nad Labem
Country [26] 0 0
Germany
State/province [26] 0 0
Schleswig-holstein
Country [27] 0 0
Germany
State/province [27] 0 0
Bad Bentheim
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Dresden
Country [30] 0 0
Germany
State/province [30] 0 0
Erlangen
Country [31] 0 0
Germany
State/province [31] 0 0
Kiel
Country [32] 0 0
Germany
State/province [32] 0 0
Munich
Country [33] 0 0
Germany
State/province [33] 0 0
Münster
Country [34] 0 0
Germany
State/province [34] 0 0
Schwerin
Country [35] 0 0
Hungary
State/province [35] 0 0
Bács-kiskun
Country [36] 0 0
Hungary
State/province [36] 0 0
Debrecen
Country [37] 0 0
Hungary
State/province [37] 0 0
Kecskemet
Country [38] 0 0
Hungary
State/province [38] 0 0
Miskolc
Country [39] 0 0
Hungary
State/province [39] 0 0
Pecs
Country [40] 0 0
Poland
State/province [40] 0 0
Katowice
Country [41] 0 0
Poland
State/province [41] 0 0
Lodz
Country [42] 0 0
Poland
State/province [42] 0 0
Ostrowiec Swietokrzyski
Country [43] 0 0
Poland
State/province [43] 0 0
Warszawa
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Devon
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Greater London
Country [46] 0 0
United Kingdom
State/province [46] 0 0
South Yorkshire, England
Country [47] 0 0
United Kingdom
State/province [47] 0 0
South Yorkshire
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Dudley

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

Ethics approval
Ethics application status

Summary
Brief summary
B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with
a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy
and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily,
will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients
will have an option to enter a long-term extension study after completing 12 weeks of
treatment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03349060
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