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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03422822
Ethics application status
Date submitted
20/12/2017
Date registered
6/02/2018
Date last updated
23/10/2024

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
JADE EXTEND B7451015
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(has expanded access)
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
Timepoint [1] 0 0
Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Primary outcome [2] 0 0
Serious adverse events and adverse events leading to discontinuation
Timepoint [2] 0 0
Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Primary outcome [3] 0 0
Change from baseline in clinical laboratory values
Timepoint [3] 0 0
Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Primary outcome [4] 0 0
Change from baseline in electrocardiogram (ECG) measurements
Timepoint [4] 0 0
Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Primary outcome [5] 0 0
Change from baseline in vital signs
Timepoint [5] 0 0
Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Secondary outcome [1] 0 0
Investigator's Global Assessment (IGA)
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)
Timepoint [2] 0 0
Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Secondary outcome [3] 0 0
Pruritus Numerical Rating Scale (NRS)
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)
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
Timepoint [5] 0 0
Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Secondary outcome [6] 0 0
Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI)
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)
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)
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)
Timepoint [9] 0 0
Baseline, Week 24, Week 48, Week 60, Week 72, Week 92
Secondary outcome [10] 0 0
Steroid-Free Days
Timepoint [10] 0 0
Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Secondary outcome [11] 0 0
Serum Hs-CRP Levels
Timepoint [11] 0 0
Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Secondary outcome [12] 0 0
Change in height standard deviation score (SDS)
Timepoint [12] 0 0
Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Secondary outcome [13] 0 0
Proportion of abnormal findings in knee MRI in adolescent subjects exposed to abrocitinib 100mg and 200mg QD
Timepoint [13] 0 0
Throughout sub-study until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued or withdrawn; an estimated maximum of 4 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.

c. 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
Sex
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.

There are also additional separate inclusion and exclusion criteria to assess eligibility specifically for the B7451015 MRI sub-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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
Accrual to date
Final
3162
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
St George Dermatology & Skin Cancer Centre - Kogarah
Recruitment hospital [3] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
The Skin Hospital - Westmead
Recruitment hospital [6] 0 0
The Skin Centre - Benowa
Recruitment hospital [7] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [8] 0 0
North Eastern Health Specialists - Campbelltown
Recruitment hospital [9] 0 0
Eastern Health - Box Hill Hospital - Box Hill
Recruitment hospital [10] 0 0
Skin Health Institute Inc. - Carlton
Recruitment hospital [11] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [12] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [13] 0 0
The Royal Children's Hospital - Parkville
Recruitment hospital [14] 0 0
Emeritus Research - Camberwell
Recruitment hospital [15] 0 0
Royal Melbourne Hospital - Parkville, VIC
Recruitment hospital [16] 0 0
Royal North Shore Hospital - Saint Leonards NSW
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2035 - Maroubra
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4217 - Benowa
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5074 - Campbelltown
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3053 - Carlton
Recruitment postcode(s) [11] 0 0
3002 - East Melbourne
Recruitment postcode(s) [12] 0 0
3050 - Parkville
Recruitment postcode(s) [13] 0 0
3052 - Parkville
Recruitment postcode(s) [14] 0 0
VIC 3124 - Camberwell
Recruitment postcode(s) [15] 0 0
3052 - Parkville, VIC
Recruitment postcode(s) [16] 0 0
2065 - Saint Leonards NSW
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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California
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Colorado
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Kentucky
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Zhejiang
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Chongqing
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Kunta Hora
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Kutná Hora
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Nachod
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Praha 10
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Praha
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Svitavy
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BO
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Italy
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CH
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Italy
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GE
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Italy
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MO
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Italy
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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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Kumamoto
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Fukuoka
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Saitama
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Daegu
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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 parent 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.

The B7451015 study also includes a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee MRI. The sub-study will be conducted in selected countries at selected sites. Eligible subjects are those who were 12 to \<18 years of age at the screening visit of the qualifying parent study and who are currently participating in the main B7451015 study. The sub-study will include serial Magnetic Resonance Imaging (MRI) annually and continue until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued/withdrawn.
Trial website
https://clinicaltrials.gov/study/NCT03422822
Trial related presentations / publications
Simpson EL, Silverberg JI, Nosbaum A, Winthrop KL, Guttman-Yassky E, Hoffmeister KM, Egeberg A, Valdez H, Zhang M, Farooqui SA, Romero W, Thorpe AJ, Rojo R, Johnson S. Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Am J Clin Dermatol. 2021 Sep;22(5):693-707. doi: 10.1007/s40257-021-00618-3. Epub 2021 Aug 18. Erratum In: Am J Clin Dermatol. 2021 Nov;22(6):905. doi: 10.1007/s40257-021-00638-z.
Public notes

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



Summary Results

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