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



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:21 - 70
Updated:11/23/2013
Start Date:November 2011
End Date:December 2013
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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A Randomized, Subject And Investigator-Blinded (Sponsor-Open), Placebo-Controlled Study To Evaluate The Safety, Tolerability, And Preliminary Efficacy Of Multiple Ascending Doses Of PD- 0360324 In Subjects With Active Cutaneous Lupus Erythematosus (CLE)


This study is designed to evaluate the safety and tolerability of multiple intravenously
administered doses of PD-0360324 in patients with cutaneous lupus erythematosus. Changes in
disease activity will also be evaluated.


Inclusion Criteria:

- 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:

- 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.
We found this trial at
13
sites
Beckley, West Virginia 25801
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Aberdeen, South Dakota 57401
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Aberdeen, SD
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Alabaster, Alabama 35007
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Alabaster, AL
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Asheville, North Carolina 28801
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Asheville, NC
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Atlantis, Florida 33462
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Atlantis, FL
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Avon, Indiana 46123
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Avon, IN
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Bloomingdale, Illinois 60108
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Bloomingdale, IL
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Bristol, Tennessee 37620
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Bristol, TN
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Burke, Virginia 22015
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Burke, VA
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Detroit, Michigan 48202
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Detroit, MI
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Houston, Texas 77030
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Houston, TX
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Los Angeles, California 90027
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Los Angeles, CA
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Pittsburgh, Pennsylvania 15212
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Pittsburgh, PA
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