Clinical Trial: A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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 Sub
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Pfizer
Current Primary Outcome: 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 ]
Original Primary Outcome: Safety and tolerability of PF 04937319 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 ]
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Pfizer
Dates:
Date Received: November 9, 2011
Date Started: November 2011
Date Completion:
Last Updated: January 27, 2014
Last Verified: January 2014