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Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

Last updated on April 22, 2019

FOR MORE INFORMATION
Study Location
Dermatology Specialists, Inc.
Murrieta, California, 92562 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dermatitis, Atopic Dermatitis, Eczema, Skin Diseases, Genetic Skin Diseases, Inborn Genetic Diseases, Eczematous Skin Diseases, Hypersensitivity, Immediate Hypersensitivity, Immune System Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male or female subjects aged 18 years or older at the time of informed consent

- 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
severity 4)

- Documented recent history (within 6 months before the screening visit) of inadequate
response to treatment with medicated topical therapy for AD for at least 4 weeks, or
who have required systemic therapies for control of their disease.

- Must be willing and able to comply with standardized background topical therapy, as
per protocol guidelines throughout the study

- Female subjects who are of childbearing potential 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.

- 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.

-If receiving concomitant medications for any reason other than AD, must be on a stable
regimen prior to Day 1 and through the duration of the study

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

- 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

- Unwilling to discontinue current AD medications prior to the study or require
treatment with prohibited medications during the study

- Other active nonAD inflammatory skin diseases or conditions affecting skin

- Prior treatment with JAK inhibitors

- Previous treatment with dupilumab

- Unwilling to discontinue current AD medications prior to the study or require
treatment with prohibited medications during the study

NCT03720470
Pfizer
Recruiting
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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