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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
6/02/2018
Date last updated
15/09/2020

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 ABROCITINIB, 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 - Abrocitinib 100 mg
Treatment: Drugs - Abrocitinib 200 mg
Treatment: Drugs - Placebo
Treatment: Drugs - Abrocitinib 100 mg
Treatment: Drugs - Abrocitinib 100 mg
Treatment: Drugs - Abrocitinib 200 mg

Experimental: Abrocitinib 100 mg - Abrocitinib 100 mg QD PO

Experimental: Abrocitinib 200 mg - Abrocitinib 200 mg QD PO


Treatment: Drugs: Abrocitinib 100 mg
In the initial treatment period, Abrocitinib 100 mg, administered as two tablets to be taken orally once daily.

Treatment: Drugs: Abrocitinib 200 mg
In the initial treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.

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

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

Treatment: Drugs: Abrocitinib 100 mg
In the secondary treatment period, Abrocitinib 100 mg, administered as one tablet to be taken orally once daily.

Treatment: Drugs: Abrocitinib 200 mg
In the secondary treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.

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
Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years
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
Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years
Primary outcome [3] 0 0
Change from baseline in clinical laboratory values - Change from baseline in clinical laboratory values
Timepoint [3] 0 0
Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years
Primary outcome [4] 0 0
Change from baseline in electrocardiogram (ECG) measurements - Change from baseline in electrocardiogram (ECG) measurements
Timepoint [4] 0 0
Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years
Primary outcome [5] 0 0
Change from baseline in vital signs - Change from baseline in vital signs
Timepoint [5] 0 0
Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years
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 72, Week 84, Week 92
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
Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years
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 72, Week 84, Week 92
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 72, Week 84, Week 92
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
Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years
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 72, Week 84, Week 92
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 72, Week 84, Week 92
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 72, Week 92
Secondary outcome [10] 0 0
Steroid-Free Days - Number of steroid-free days will be assessed throughout the duration of the study.
Timepoint [10] 0 0
Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years
Secondary outcome [11] 0 0
Serum Hs-CRP Levels - Serum Hs-CRP levels at all scheduled time points
Timepoint [11] 0 0
Throughout study until availability of commercial product in a country, or until the sponsor terminates the study in that country; an estimated maximum of 5 years

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 meets inclusion criterion for minimum body weight (if applicable) from qualifying
Parent study. Adolescent subjects below the age of 18 years old (or country-specific
age of majority) 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 (or country-specific age of majority) 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 Parent study OR must
have completed the full rescue treatment period of a qualifying Parent study (if
applicable) OR must have completed the full open-label run-in period in B7451014 and
did not meet the protocol-specified response criteria at Week 12.

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 ot
be intending to become pregnant, currently pregnant, or lactating. The following
onditions apply:

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

2. Female subjects of childbearing potential must agree to use a highly effective
method of contraception (as per Section 4.4.1) for the duration of the active
treatment period and for at least 28 days after the last dose of investigational
product.

For Czech Republic only, 5 b. is revised and 5 c. is added to require:

Female subjects of childbearing potential 15 years of age who are at risk of
pregnancy 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.

3. Female subjects less than 15 years of age must not be sexually active, and
abstinence per the below definition should be confirmed prior to enrollment.
NOTE: Sexual abstinence, defined as completely and persistently refraining from
all heterosexual intercourse (including during the entire period of risk
associated with the study treatments) may obviate the need for contraception ONLY
if this is the preferred and usual lifestyle of the subject.

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
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 AD or have
evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of
Day -1 that would interfere with evaluation of atopic dermatitis or response to treatment.

3. Discontinued from treatment (or rescue treatment period/open-label run-in period, if
applicable) early in a qualifying Parent study OR triggered a discontinuation criterion at
any point during the qualifying Parent study which in the opinion of the investigator, or
sponsor, is an ongoing safety concern.

4. Ongoing adverse event in the qualifying Parent study which in the opinion of the
investigator, or sponsor, is an ongoing safety concern. 5. 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)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [3] 0 0
The Skin Hospital - Westmead
Recruitment hospital [4] 0 0
The Skin Centre - Benowa
Recruitment hospital [5] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [6] 0 0
North Eastern Health Specialists - Hectorville
Recruitment hospital [7] 0 0
Eastern Health - Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
Skin Health Institute Inc. - Carlton
Recruitment hospital [9] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [10] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [11] 0 0
The Royal Children's Hospital - Parkville
Recruitment hospital [12] 0 0
Emeritus Research - Camberwell
Recruitment hospital [13] 0 0
Royal Melbourne Hospital - Parkville, VIC
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4217 - Benowa
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5073 - Hectorville
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3053 - Carlton
Recruitment postcode(s) [9] 0 0
3002 - East Melbourne
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment postcode(s) [11] 0 0
3052 - Parkville
Recruitment postcode(s) [12] 0 0
VIC 3124 - Camberwell
Recruitment postcode(s) [13] 0 0
3052 - Parkville, VIC
Recruitment outside Australia
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Arizona
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BO
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CH
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GE
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MO
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Milano
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Roma
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Rome
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Chiba
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Hyogo
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Kanagawa
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Kumamoto
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Tokyo
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Fukuoka
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Saitama
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Riga
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Yaxley

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 Abrocitinib with or without Topical Medications in
patients aged 12 years and older who have moderate to severe atopic dermatitis and have
completed a qualifying Phase 3 study. The efficacy and safety of two dosage strengths of
Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable
lengths of study participation. The study consists of a 92 week initial treatment period
followed by a variable length secondary treatment period during which subjects will receive
treatment with open-label abrocitinib until availability of commercial product in their
country, or until the sponsor terminates the study in that country
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03422822