A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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)|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Measure changes in systemic features using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Measure changes in biomarkers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Assess health outcomes measures [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Evaluate the Pharmacokinetics of PD-0360324 [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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 Comparator: 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).
Show 21 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|