Conditions: Lupus Nephritis
Keywords: Systemic Lupus Erythematosus (SLE) Lupus Nephritis Laquinimod
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 46
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants will receive 2 capsules of placebo matching to laquinimod orally once daily (QD) for 24 weeks, MMF 500 mg tablet orally twice daily (BID) for the first week then 1 gram (g) BID from Week 2 to Week 28, and MP 500 mg/day intravenously (IV) from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. arm 2: Participants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matching to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. arm 3: Participants will receive 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.

Interventions: intervention 1: Laquinimod intervention 2: Mycophenolate Mofetil intervention 3: Prednisolone/Prednisone intervention 4: Placebo intervention 5: Methylprednisolone
Intervention descriptions: intervention 1: Laquinimod will be administered per dose and schedule specified in the arm description. intervention 2: Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description. intervention 3: Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description. intervention 4: Placebo matching to laquinimod will be administered per schedule specified in the arm description. intervention 5: Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.

Protocol document: