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.
The trial was terminated prematurely on Oct 15, 2013 due to a business decision. The decision to terminate the trial was not based on any clinical safety or efficacy concerns.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Subjects will receive PD-0360324 intravenously in 3 different cohorts. The cohorts will be evaluated in ascending fashion. The doses planned are 100 mg every other week for 3 months, 150 mg every other week for 3 months, and 200 mg every 4 weeks for 3 months.
Placebo is normal saline. The timing of placebo administration will depend of the dosing frequency of the cohort (either every other week for 3 months or every 4 weeks for 3 months).
Pfizer Investigational Site
Anniston, Alabama, United States
Pfizer Investigational Site
Oxford, Alabama, United States
Safety and tolerability of PD- 0360324 will be assessed by physical examinations, adverse event and infection monitoring, 12 lead ECGs, vital sign, and clinical safety laboratory measurements.
Time frame: 16 Weeks
Efficacy of PD-0360324 based upon reduction of severity of symptoms as measured using the activity score of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
Time frame: 12 Weeks
Measure changes in systemic features using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Time frame: 12 Weeks
Measure changes in biomarkers
Time frame: 12 weeks
Assess health outcomes measures
Time frame: 12 Weeks
Evaluate the Pharmacokinetics of PD-0360324
Time frame: 16 Weeks
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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
...and 9 more locations