A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus
NCT ID: NCT01470313
Last Updated: 2014-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
28 participants
INTERVENTIONAL
2011-11-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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PD-0360324
PD-0360324
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
Placebo
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).
Interventions
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PD-0360324
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
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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References
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Masek-Hammerman K, Peeva E, Ahmad A, Menon S, Afsharvand M, Peng Qu R, Cheng JB, Syed J, Zhan Y, O'Neil SP, Pleasic-Williams S, Cox LA, Beidler D. Monoclonal antibody against macrophage colony-stimulating factor suppresses circulating monocytes and tissue macrophage function but does not alter cell infiltration/activation in cutaneous lesions or clinical outcomes in patients with cutaneous lupus erythematosus. Clin Exp Immunol. 2016 Feb;183(2):258-70. doi: 10.1111/cei.12705. Epub 2015 Nov 9.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6261008
Identifier Type: -
Identifier Source: org_study_id
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