Study of LJP 394 (Abetimus Sodium) in Lupus Patients
| Status: | Withdrawn |
|---|---|
| Conditions: | Lupus |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 12 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | September 2006 |
A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE)
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.
394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with
SLE.
STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.
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.
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