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A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cutaneous Lupus Erythematosus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male and/or female subjects between the ages of 21 to 70 who have a clinical diagnosis
of either discoid cutaneous lupus erythematosus or subacute cutaneous lupus
erythematosus with or without systemic lupus erythematosus prior to screening that has
been confirmed by evaluation of skin biopsy sample.

- Active disease at both screening and baseline (Day 1) defined by a CLASI score of
greater than or equal to 10.

- Intolerance to antimalarial therapy or more than 3 months of antimalarial therapy with
disease activity.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Use of greater than or equal to 20 mg or prednisone (or equivalent) within 3 months of
Day 1.

- Signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic
infection, or recent history of repeated infections

- Subjects with evidence of past or active tuberculosis

- Pregnant, planning to get pregnant, and/or lactating females or males planning to
father a child within time period of the study or subsequent exclusionary period.

NCT01470313
Pfizer
Terminated
A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus

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