Study of LJP 394 (Abetimus Sodium) in Lupus Patients

Withdrawn before enrolling · Phase 2

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT00390091

Run by

La Jolla Pharmaceutical Company

People needed

0

Starts

2006-09-01

Last updated by the study team

2015-09-01

Who can join

Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Wallace Rheumatic Study Center — Los Angeles, California, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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