NCT01085097

A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Laquinimod	Laquinimod will be administered per dose and schedule specified in the arm description.
DRUG	Mycophenolate Mofetil	Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.
DRUG	Prednisolone/Prednisone	Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.
DRUG	Placebo	Placebo matching to laquinimod will be administered per schedule specified in the arm description.
DRUG	Methylprednisolone	Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-10-24
• Completion: 2012-10-24
• First posted: 2010-03-11
• Last updated: 2022-03-09
• Results posted: 2022-03-09

Locations

30 sites across 5 countries: United States, Canada, France, Russia, United Kingdom