Study of LJP 394 (Abetimus Sodium) in Lupus Patients

La Jolla Pharmaceutical Company

Overview

The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP 394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.

STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Conditions

Systemic Lupus Erythematosus

Interventions

abetimus sodium (LJP 394)DRUG

Eligibility

Sex: ALLMin age: 12 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females between 12 and 70 years old. * Diagnosis of Systemic Lupus Erythematosus (SLE) * Females must be non-pregnant and non-lactating. Females must agree to use adequate birth control methods during the course of the study. * Ability to have weekly intravenous (IV) administration of study drug. Exclusion Criteria: * Prior exposure to abetimus sodium within 6 months prior to screening. * Patients not on stable medications for 30 days prior to screening. * Patients with acute or chronic infections.

Locations (2)

Wallace Rheumatic Study Center

Los Angeles, California, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Outcomes

Primary Outcomes

The assessment of the safety and pharmacodynamic effect of abetimus sodium at

doses of 100mg, 300mg, and 900mg in reducing the anti-dsDNA antibody levels in

patients with SLE will be based on laboratory data from the central laboratory

and confirmed by supporting data. The pharmacodynamic effic will be assessed

using historical placebo effect as a control.

Data from ClinicalTrials.gov

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