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Clinical Trials List

Protocol NumberB7451015
NCT Number(ClinicalTrials.gov Identfier)NCT03422822

2018-03-08 - 2021-07-04

Phase III

Recruiting9

ICD-10L20.9

Atopic dermatitis, unspecified

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

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

    Pfizer

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 賴柏如 Division of Dermatology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tak-Wah Wong Division of Dermatology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Huei Huang Division of Dermatology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Chiang Chen Division of Dermatology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YI-JU CHEN Division of Dermatology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳南霖 Division of Dermatology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Woan-Ruoh Lee Division of Dermatology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

2 Recruiting

Audit

CRO

Principal Investigator Chia-Yu Chu Division of Dermatology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Che Lan Division of Dermatology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Atopic dermatitis (AD)

Objectives

To evaluate and compare the maintenance of effect of two doses of PF-04965842 (200 mg and 100 mg once daily (QD)) and Placebo in subjects aged 12 and above with moderate to severe atopic dermatitis who respond to initial open-label run-in treatment of 200 mg PF-04965842 QD.

Test Drug

PF-04965842

Active Ingredient

PF-04965842

Dosage Form

tablet

Dosage

100

Endpoints

Primary Outcome Measures :
Loss of response [ Time Frame: Randomization (Week 12) to Week 52 ]
Loss of response requiring rescue treatment will be evaluated and compared among groups during the blinded treatment period. Loss of response is denoted as flare and is defined as a loss of at least 50% of the Eczema Area and Severity Index (EASI) response at Week 12 and an Investigator's Global Assessment (IGA) score of 2 or higher.


Secondary Outcome Measures :
Investigator's Global Assessment (IGA) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 28, 40, 52 and Rescue Weeks 0, 2, 4, 8, 12, and follow up (defined as 4 weeks post last dose) ]
Response based on the IGA at all scheduled time points.

Eczema Area and Severity Index (EASI) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 28, 40, 52 and Rescue Weeks 0, 2, 4, 8, 12, and follow up (defined as 4 weeks post last dose) ]
Response based on EASI total score at all scheduled time points.

Pruritus Numberical Rating Scale (NRS) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 28, 40, 52 and Rescue Weeks 0, 2, 4, 8, 12, and follow up (defined as 4 weeks post last dose) ]
Response based on at least 4 points improvement in the severity of pruritus NRS from relevant baseline at all scheduled time points. Severity is on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable."

Body Surface Area (BSA) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 28, 40, 52 and Rescue Weeks 0, 2, 4, 8, 12, and follow up (defined as 4 weeks post last dose) ]
Change from relevant baseline in percent BSA at all scheduled time points.

SCORing Atopic Dermatitis (SCORAD) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 28, 40, 52 and Rescue Weeks 0, 2, 4, 8, 12, and follow up (defined as 4 weeks post last dose) ]
Change from relevant baseline in SCORAD subjective assessments of itch and sleep loss at all scheduled time points. Includes proportion of subjects achieving a >=50% and >=75% improvement in SCORAD (SCORAD-50, SCORAD-75) from relevant baseline at all scheduled time points.

Patient Global Assessment (PtGA) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 28, 40, 52 and Rescue Weeks 0, 2, 4, 8, 12, and follow up (defined as 4 weeks post last dose) ]
Change from relevant baseline in PtGA at all scheduled time points.

Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 28, 40, 52 and Rescue Weeks 0, 2, 4, 8, 12, and follow up (defined as 4 weeks post last dose) ]
Change from relevant baseline in DLQI or CDLQI at all scheduled time points.

Hospital Anxiety Depression Scale (HADS) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 28, 40, 52 and Rescue Weeks 0, 2, 4, 8, 12, and follow up (defined as 4 weeks post last dose) ]
Change from relevant baseline in HADS at all scheduled time points. Each question has 0 to 3 scale with 0 being the best "not at all/hardly at all" and 3 being the worst "most of the time/nearly all of the time."

Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 28, 40, 52 and Rescue Weeks 0, 2, 4, 8, 12, and follow up (defined as 4 weeks post last dose) ]
Change from relevant baseline in POEM at all scheduled time points.

Pruritus and symptoms Assessment in Atopic Dermatitis (PSAAD) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 28, 40, 52 and Rescue Weeks 0, 2, 4, 8, 12, and follow up (defined as 4 weeks post last dose) ]
Change from relevant baseline in the PSAAD at all scheduled time points.

EuroQol Quality of LIfe 5-Dimension 5-Level Scale (EQ-5D-5L) or Youth Scale (EQ-5D-Y) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 28, 40, 52 and Rescue Weeks 0, 2, 4, 8, 12, and follow up (defined as 4 weeks post last dose) ]
Change from relevant baseline in EQ-5D-5L or EQ-5D-Y at all scheduled time points.

Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) or Pediatric FACIT-F (Peds-FACIT-F) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 28, 40, 52 and Rescue Weeks 0, 2, 4, 8, 12, and follow up (defined as 4 weeks post last dose) ]
Change from relevant baseline in FACIT-F or Peds-FACIT-F at all scheduled time points.

Short Form-36, acute (SF-36) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 28, 40, 52 and Rescue Weeks 0, 2, 4, 8, 12, and follow up (defined as 4 weeks post last dose) ]
Change from relevant baseline in SF-36, acute (adults only) at all scheduled time points.

Investigator's Global Assessment (IGA) [ Time Frame: Randomization (Week 12) to Week 52 ]
Key Secondary Endpoint: Loss of response based on an IGA score of 2 or higher.

Inclution 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 ≥ 40 kg. Adolescent subjects below the legal age of majority (legal
adulthood) in the subject’s country will only be enrolled in this study if instructed by
the sponsor and approved by the country’s regulatory/health authority. If these
approvals have not been granted, only subjects  the legal age of majority (legal
adulthood) in the subject’s country will be enrolled.
3. Meet all the following atopic dermatitis criteria:
 Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for
at least 1 year prior to Day 1 and has confirmed atopic dermatitis at the screening
and baseline visits according to Hanifin and Rajka criteria of AD43 (see Appendix 2).
 Documented recent history (within 6 months before the screening visit) of
inadequate response to treatment with topical medications for at least 4 weeks, or
for whom topical treatments are inadequate, or who have required systemic
therapies for control of their disease.
 Moderate to severe AD (affected BSA 10%, IGA 3, EASI 16 and pruritus
NRS 4 at the baseline visit).
4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and
other study procedures.
5. Female subjects who are of child-bearing potential (which includes adolescents 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:
a. Female subjects of childbearing potential must have a confirmed negative
pregnancy test prior to treatment with investigational product;
b. 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.
NOTE: Sexual abstinence, defined as completely and persistently refraining from all
heterosexual intercourse (including during the entire period of risk associated with
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:
 Have undergone a documented hysterectomy and/or bilateral oophorectomy;
 Have medically confirmed ovarian failure; or
 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.

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. Any psychiatric condition including recent or active suicidal ideation or behavior that
meets any of the following criteria:
 Suicidal ideation associated with actual intent and a method or plan in the past
year: “Yes” answers on items 4 or 5 of the Columbia suicide severity rating scale
(C-SSRS) (Appendix 15);
 Previous history of suicidal behaviors in the past 5 years: “Yes” answer (for
events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS;
 Any lifetime history of serious or recurrent suicidal behavior;
 Suicidal behaviors questionnaire – revised (SBQ-R) total score 8 (Appendix 16);
 Clinically significant depression: patient health questionnaire – 8 items (PHQ-8)
total score 15 (Appendix 17);
 The presence of any current major psychiatric disorder that is not explicitly
permitted in the inclusion/exclusion criteria;
 In the opinion of the investigator or Pfizer (or designee) exclusion is required.
3. A current or past medical history of conditions associated with thrombocytopenia,
coagulopathy or platelet dysfunction.
4. Receiving anti-coagulants or medications known to cause thrombocytopenia (unless
considered safe to stop and washout for the duration of the study).
5. 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.
6. Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the
first dose of investigational product, or is expected to be vaccinated or to have
household exposure to these vaccines during treatment or during the 6 weeks
following discontinuation of investigational product.
7. Adolescent subjects 12 to <18 years old without documented evidence of having
received at least one dose of the varicella vaccine in countries where the vaccine is
approved and standard of care or those who do not have evidence of prior exposure to
varicella zoster virus (VZV) based on serological testing (ie, varicella zoster virus
immunoglobulin G antibody [VZV IgG Ab]) at screening.
8. Subjects who have received prior treatment with any JAK inhibitors.

The Estimated Number of Participants

  • Taiwan

    43 participants

  • Global

    2300 participants

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