Study of LJP 394 (Abetimus Sodium) in Lupus Patients

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00390091
• Other study ID #: LJP 394-90-16
• Status: Withdrawn
• Phase: Phase 2
• First received: October 17, 2006
• Last updated: August 31, 2015
• Start date: September 2006

Study information

• Verified date: February 2007
• Source: La Jolla Pharmaceutical Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• abetimus sodium (LJP 394)

Locations

Country	Name	City	State
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Wallace Rheumatic Study Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
La Jolla Pharmaceutical Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The assessment of the safety and pharmacodynamic effect of abetimus sodium at
Primary	doses of 100mg, 300mg, and 900mg in reducing the anti-dsDNA antibody levels in
Primary	patients with SLE will be based on laboratory data from the central laboratory
Primary	and confirmed by supporting data. The pharmacodynamic effic will be assessed
Primary	using historical placebo effect as a control.

External Links

•   Sponsor's website
•   STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804