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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03422822




Registration number
NCT03422822
Ethics application status
Date submitted
20/12/2017
Date registered
30/01/2018
Date last updated
29/01/2019

Titles & IDs
Public title
Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
Scientific title
A PHASE 3 MULTI-CENTER, LONG-TERM EXTENSION STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842, WITH OR WITHOUT TOPICAL MEDICATIONS, ADMINISTERED TO SUBJECTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Secondary ID [1] 0 0
2017-004851-22
Secondary ID [2] 0 0
B7451015
Universal Trial Number (UTN)
Trial acronym
JADE EXTEND
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
Treatment: Drugs - PF-04965842 100 mg

Experimental: PF-04965842 100 mg -

Experimental: PF-04965842 200 mg -


Treatment: Drugs: PF-04965842 100 mg
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for up to 92 weeks.

Treatment: Drugs: PF-04965842 200 mg
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for up to 92 weeks

Treatment: Drugs: Placebo
For subjects whose dose was changed from 100 mg PF-04965842 to placebo, one tablet will be administered to be taken orally once daily for the remainder of the study.

Treatment: Drugs: PF-04965842 100 mg
For subjects whose dose was changed from 200 mg PF-04965842 to 100 mg PF-04965842, one tablet will be administered to be taken orally once daily for the remainder of the study.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment emergent adverse events - The incidence of treatment emergent adverse events
Timepoint [1] 0 0
Up to 96 weeks
Primary outcome [2] 0 0
Serious adverse events and adverse events leading to discontinuation - The incidence of serious adverse events and adverse events leading to discontinuation
Timepoint [2] 0 0
Up to 96 weeks
Primary outcome [3] 0 0
Change from baseline in clinical laboratory values - Change from baseline in clinical laboratory values
Timepoint [3] 0 0
Up to 96 weeks
Primary outcome [4] 0 0
Change from baseline in electrocardiogram (ECG) measurements - Change from baseline in electrocardiogram (ECG) measurements
Timepoint [4] 0 0
Up to 96 weeks
Primary outcome [5] 0 0
Change from baseline in vital signs - Change from baseline in vital signs
Timepoint [5] 0 0
Up to 96 weeks
Secondary outcome [1] 0 0
Investigator's Global Assessment (IGA) - Response based on the IGA score of clear (0) or almost clear (1) (on a 5 point scale) and a reduction from baseline of >=2 points at all scheduled time points
Timepoint [1] 0 0
Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96
Secondary outcome [2] 0 0
Eczema Area and Severity Index (EASI) - Response based on greater than or equal to 50%, 75% and 90% improvement from baseline in the EASI total score (EASI50, EASI75, and EASI90) at all scheduled time points
Timepoint [2] 0 0
Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96
Secondary outcome [3] 0 0
Pruritus Numerical Rating Scale (NRS) - Response based on an improvement greater than or equal to 3 points and greater than or equal to 4 points from baseline in the pruritus NRS at all scheduled time points
Timepoint [3] 0 0
Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96
Secondary outcome [4] 0 0
Patient Global Assessment (PtGA) - Change from baseline of PtGA at all scheduled time points
Timepoint [4] 0 0
Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96
Secondary outcome [5] 0 0
Body Surface Area (BSA) affected - Change from baseline in the percentage BSA affected at all scheduled time points
Timepoint [5] 0 0
Baseline, Week 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96
Secondary outcome [6] 0 0
Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI) - Change from baseline in DLQI or CDLQI at all scheduled time points
Timepoint [6] 0 0
Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96
Secondary outcome [7] 0 0
Patient Oriented Eczema Measure (POEM) - Change from baseline in POEM at all scheduled time points
Timepoint [7] 0 0
Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96
Secondary outcome [8] 0 0
Hospital Anxiety and Depression Scale (HADS) - Change from baseline in HADS at all scheduled time points
Timepoint [8] 0 0
Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 64, Week 72, Week 84, Week 92, Week 96
Secondary outcome [9] 0 0
EuroQol Quality of Life 5 Dimension 5 Level Scale (EQ-5D-5L) or EuroQol Quality of Life 5 Dimension Youth Scale (EQ-5D-Y) - Change from baseline of EQ-5D-5L or EQ-5D-Y at all scheduled time points
Timepoint [9] 0 0
Baseline, Week 24, Week 48, Week 60, Week 64, Week 72, Week 92, Week 96

Eligibility
Key inclusion criteria
- 1. Evidence of a personally signed and dated informed consent document indicating that
the subject or their parent(s)/legal guardian, if applicable, have been informed of
all pertinent aspects of the study.

2. Male or female subjects of 12 years of age or older, at the time of informed
consent and body weight greater than or equal to 40 kg. Adolescent subjects below the
age of 18 years old will only be enrolled in this study if instructed by the sponsor
and approved by the country or regulatory/health authority. If these approvals have
not been granted, only subjects aged 18 years and older will be enrolled.

3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests
and other study procedures.

4. Must have completed the full treatment period of a qualifying Phase 3 study OR must
have completed the full rescue treatment period of a qualifying Phase 3 study (if
applicable).

5. Female subjects who are of childbearing potential (which includes all female
subjects aged 12 years and older, regardless of whether they have experienced
menarche) must not be intending to become pregnant, currently pregnant, or lactating.
The following conditions apply:

1. Female subjects of childbearing potential must have a confirmed negative
pregnancy test prior to randomization.

2. Female subjects of childbearing potential must agree to use a highly effective
method of contraception for the duration of the active treatment period and for
at least 28 days after the last dose of investigational product.

6. Female subjects of non childbearing potential must meet at least 1 of the
following criteria:

1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

2. Have medically confirmed ovarian failure; or

3. Achieved postmenopausal status, defined as follows: cessation of regular menses
for at least 12 consecutive months with no alternative pathological or
physiological cause and have a serum follicle stimulating hormone (FSH) level
confirming the postmenopausal state.

All other female subjects (including female subjects with tubal ligations) are
considered to be of childbearing potential.

7. Must agree to avoid prolonged exposure to the sun and not to use tanning
booths, sun lamps or other ultraviolet light sources during the study.

8. Must agree to avoid use of prohibited medications throughout the duration of
the study.
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Other acute or chronic medical or psychiatric condition including recent
(within the past year) or active suicidal ideation or behavior or laboratory
abnormality that may increase the risk associated with study participation
or investigational product administration or may interfere with the
interpretation of study results and, in the judgment of the investigator,
would make the subject inappropriate for entry into this study.

2. Currently have active forms of other inflammatory skin diseases, ie, not
atopic dermatitis.

3. Have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis,
Lupus) at the time of Day 0 that would interfere with evaluation of atopic
dermatitis or response to treatment.

4. Discontinued from treatment (or rescue treatment period, if applicable)
early in a qualifying Phase 3 study OR triggered discontinuation criteria at
any point during the qualifying Phase 3 study OR meets exclusion criteria of
the qualifying Phase 3 study.

5. Ongoing adverse event in the qualifying Phase 3 study which in the opinion
of the investigator, or sponsor, is an ongoing safety concern OR the subject
is currently triggering safety monitoring criteria in the qualifying Phase 3
study.

6. Investigator site staff members directly involved in the conduct of the
study and their family members, site staff members otherwise supervised by
the investigator, or subjects who are Pfizer employees, including their
family members, directly involved in the conduct of the study.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [2] 0 0
Spectrum Medical Imaging - Maroubra
Recruitment hospital [3] 0 0
The Skin Centre - Benowa
Recruitment hospital [4] 0 0
Queensland X-Ray - Upper Mount Gravatt
Recruitment hospital [5] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [6] 0 0
Emeritus Research - Camberwell
Recruitment hospital [7] 0 0
MIA Radiology - Camberwell
Recruitment hospital [8] 0 0
Skin and Cancer Foundation Inc - Carlton
Recruitment hospital [9] 0 0
Uniradiology - Carlton
Recruitment hospital [10] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [11] 0 0
The Royal Children's Hospital - Parkville
Recruitment hospital [12] 0 0
Bridge Road Imaging - Richmond
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
4122 - Upper Mount Gravatt
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment postcode(s) [6] 0 0
3053 - Carlton
Recruitment postcode(s) [7] 0 0
3002 - East Melbourne
Recruitment postcode(s) [8] 0 0
3052 - Parkville
Recruitment postcode(s) [9] 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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
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Massachusetts
Country [13] 0 0
United States of America
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Michigan
Country [14] 0 0
United States of America
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Missouri
Country [15] 0 0
United States of America
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New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
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Ohio
Country [18] 0 0
United States of America
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Oklahoma
Country [19] 0 0
United States of America
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Oregon
Country [20] 0 0
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Pennsylvania
Country [21] 0 0
United States of America
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South Carolina
Country [22] 0 0
United States of America
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South Dakota
Country [23] 0 0
United States of America
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Tennessee
Country [24] 0 0
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Texas
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Virginia
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United States of America
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Washington
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Bulgaria
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Dupnitsa
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Bulgaria
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Sofia
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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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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Ostrava - Poruba
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Czechia
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Praha 1
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Czechia
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Praha 2
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Czechia
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Usti nad Labem
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Germany
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Bad Bentheim
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Berlin
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Erlangen
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Muenster
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Schwerin
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Budapest
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Hungary
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Debrecen
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Pecs
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Szolnok
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Kumamoto
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Fukuoka
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Saitama
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Korea, Republic of
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Gyeonggi-do
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Gyeongsangnam-do
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Daegu
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Gwangju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Poland
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Lodzkie
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Bialystok
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Gdansk
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Katowice
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Krakow
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Lodz
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Lublin
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Poland
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Ostrowiec Swietokrzyski
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Poland
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Poznan
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Poland
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Szczecin
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Tarnow
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Warszawa
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Wroclaw
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Spain
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Madrid
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Cordoba
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Spain
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Sevilla
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Spain
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Valencia
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United Kingdom
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Lancashire
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United Kingdom
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South Yorkshire
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London
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United Kingdom
State/province [84] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
B7451015 is a Phase 3 study to evaluate PF-04965842 with or without Topical Medications in
patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to
severe atopic dermatitis and have completed a qualifying Phase 3 study. The efficacy and
safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily,
will be evaluated over approximately two years of study participation. Patients who meet
safety step-down criteria will have their dose reduced once, from 200 mg QD to 100 mg QD, or
from 100 mg QD to placebo.
Trial website
https://clinicaltrials.gov/show/NCT03422822
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
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable