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

Pfizer

Status and phase

Terminated

Phase 1

Conditions

Cutaneous Lupus Erythematosus

Treatments

Drug: Placebo

Drug: PD-0360324

Study type

Interventional

Funder types

Industry

Identifiers

NCT01470313

A6261008

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

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.