drugset / Trial / NCT01085097
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
RandomizedParallel-groupTriple-blindTreatment
Summary
The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules in active lupus nephritis participants. This study will assess Laquinimod doses of 0.5 milligrams (mg)/day and 1 mg/day in combination with standard of care treatment (mycophenolate mofetil \[MMF\] and corticosteroids). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.
Timeline
- Start
- 2010-09-01
- Primary completion
- 2012-10-24
- Completion
- 2012-10-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Laquinimod | Small molecule | 0.5 mg | Oral |
| Subject | Laquinimod | Small molecule | 1 mg | Oral |
| Background | Methylprednisolone | Other / unclassified | 500 mg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 1 g | Oral |
| Background | Prednisolone | Other / unclassified | — | Oral |
| Background | Prednisone | Other / unclassified | — | Oral |