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Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Clinical Research Center of Alabama
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects between 18 75 years of age, inclusive, at time of informed
consent.

- Must have the following atopic dermatitis criteria:

1. Have a 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
(Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.

2. Have inadequate response to treatment with topical medications given for at least
4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg,
because of important side effects or safety risks) within 12 months of the first
dose of study drug.

3. Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the
screening and baseline visits).

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

- History of human immunodeficiency virus (HIV) or positive HIV serology at screening,

- Infected with hepatitis B or hepatitis C viruses.

- Have evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis (TB)

- Have received any of the following treatment regiments specified in the timeframes
outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of
first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks
of first dose of study drug: Participation in other studies involving investigational
drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or
attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy
(NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning
booth/parlor.

Within 1 week of first dose of study drug: Topical treatments that could affect atopic
dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.

NCT02780167
Pfizer
Completed
Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

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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]

Call Now