Study of LJP 394 (Abetimus Sodium) in Lupus Patients

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: La Jolla Pharmaceutical Company
• Treatments: Abetimus

Criteria

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.