A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus

Phase 1

Terminated

• Conditions: Cutaneous Lupus Erythematosus
• Interventions: Drug: PD-0360324; Drug: Placebo

• Registration Number: NCT01470313
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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 10.
• 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 1.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-0360324	PD-0360324	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇲🇩 Chisinau, Moldova, Republic of