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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Cutaneous Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT01470313

Run by

Pfizer

People needed

28

Starts

2011-11-01

Expected to finish

2013-11-01

Last updated by the study team

2014-01-29

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Anniston, Alabama, United States
• Pfizer Investigational Site — Oxford, Alabama, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Orange Park, Florida, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Fort Gratiot, Michigan, United States
• Pfizer Investigational Site — Charlotte, North Carolina, United States
• Pfizer Investigational Site — Ducansville, Pennsylvania, United States
• Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
• Pfizer Investigational Site — Wyomissing, Pennsylvania, United States
• Pfizer Investigational Site — Rapid City, South Dakota, United States
• Pfizer Investigational Site — Rapid City, South Dakota, United States
• Pfizer Investigational Site — Jackson, Tennessee, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — Norfolk, Virginia, United States
• Pfizer Investigational Site — Clarksburg, West Virginia, United States
• Pfizer Investigational Site — Markham, Ontario, Canada
• Pfizer Investigational Site — Chisinau, Moldova

Full record on ClinicalTrials.gov

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