Study of LJP 394 (Abetimus Sodium) in Lupus Patients

Phase 2

Withdrawn

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT00390091
• Lead Sponsor: La Jolla Pharmaceutical Company

Brief 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.

Detailed Description

STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-17
• Study First Posted: 2006-10-19
• Status Verified: 2007-02
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
and confirmed by supporting data. The pharmacodynamic effic will be assessed
using historical placebo effect as a control.
patients with SLE will be based on laboratory data from the central laboratory
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

Trial Locations

Locations (2)

Wallace Rheumatic Study Center; 🇺🇸 Los Angeles, California, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States