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See termination reason in detailed description.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-0360324 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-0360324 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 Weeks | |
| Measure changes in systemic features using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Anniston | Alabama | 36207 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26376111 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo | Drug | 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). |
|
| 12 Weeks |
| Measure changes in biomarkers | 12 weeks |
| Assess health outcomes measures | 12 Weeks |
| Evaluate the Pharmacokinetics of PD-0360324 | 16 Weeks |
| Oxford |
| Alabama |
| 36203 |
| United States |
| Pfizer Investigational Site | Los Angeles | California | 90045 | United States |
| Pfizer Investigational Site | Orange Park | Florida | 32073 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60611 | United States |
| Pfizer Investigational Site | Indianapolis | Indiana | 46256 | United States |
| Pfizer Investigational Site | Fort Gratiot | Michigan | 48059 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28210 | United States |
| Pfizer Investigational Site | Ducansville | Pennsylvania | 16635 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Pfizer Investigational Site | Wyomissing | Pennsylvania | 19610 | United States |
| Pfizer Investigational Site | Rapid City | South Dakota | 57701 | United States |
| Pfizer Investigational Site | Rapid City | South Dakota | 57702 | United States |
| Pfizer Investigational Site | Jackson | Tennessee | 38305 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Norfolk | Virginia | 23507 | United States |
| Pfizer Investigational Site | Clarksburg | West Virginia | 26301 | United States |
| Pfizer Investigational Site | Markham | Ontario | L3P 1A8 | Canada |
| Pfizer Investigational Site | Chisinau | 2025 | Moldova |
| ID | Term |
|---|---|
| D008178 | Lupus Erythematosus, Cutaneous |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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