Study of LJP 394 (Abetimus Sodium) in Lupus Patients

La Jolla Pharmaceutical

Status and phase: Withdrawn; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: abetimus sodium (LJP 394)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00390091

LJP 394-90-16

Details and patient eligibility

About

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.

Full description

STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind