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)

Pfizer1 site in 1 country28 target enrollmentNovember 2011

ConditionsCutaneous Lupus Erythematosus

InterventionsPD-0360324 Placebo

DrugsPD-0360324 Placebo

Overview

Phase: Phase 1
Intervention: PD-0360324
Conditions: Cutaneous Lupus Erythematosus
Sponsor: Pfizer
Enrollment: 28
Locations: 1
Primary Endpoint: 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.
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 Description

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.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

November 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and/or female subjects between the ages of 21 to 70 who have a clinical diagnosis of either discoid cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus with or without systemic lupus erythematosus prior to screening that has been confirmed by evaluation of skin biopsy sample.
•Active disease at both screening and baseline (Day 1) defined by a CLASI score of greater than or equal to
•Intolerance to antimalarial therapy or more than 3 months of antimalarial therapy with disease activity.

Exclusion Criteria

•Use of greater than or equal to 20 mg or prednisone (or equivalent) within 3 months of Day
•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.

Arms & Interventions

PD-0360324

Intervention: PD-0360324

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)(12 Weeks)
Measure changes in biomarkers(12 weeks)
Assess health outcomes measures(12 Weeks)
Evaluate the Pharmacokinetics of PD-0360324(16 Weeks)