Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Nephritis

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules in active lupus nephritis patients. This study will assess Laquinimod doses of 0.5mg /day and 1 mg/day in combination with standard of care treatment (mycophenolate mofetil and corticosteroids). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.

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

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

Inclusion Criteria:

1. Subjects diagnosed with SLE

2. Kidney biopsy within 12 months prior to baseline with a histological diagnosis of proliferative or membranous Lupus Nephritis

3. Clinically active Lupus Nephritis as evident by urine protein to creatinine ratio

Exclusion Criteria:

1. Subjects with severe renal impairment or dialysis

2. Subjects with a clinically significant or unstable medical or surgical condition

3. Women who are pregnant or nursing or who intend to be during the study period.

4. Women of child-bearing potential who do not practice an acceptable method of birth control