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

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Lupus Nephritis

Treatments: Drug: Methylprednisolone; Drug: Laquinimod; Drug: Placebo; Drug: Mycophenolate Mofetil; Drug: Prednisolone/Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01085097

LN-LAQ-201

2010-018329-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants diagnosed with SLE
• Kidney biopsy within 12 months prior to baseline with a histological diagnosis of proliferative or membranous Lupus Nephritis (LN)
• Clinically active Lupus Nephritis as evident by urine protein-to-creatinine ratio (UPCR) of 1 or higher, for LN classes III, IV, or class V in combination with classes III or IV, or a UPCR of 2 or higher for LN class V, at screening or any time between screening and baseline.

Exclusion criteria

• Participants with severe renal impairment or dialysis
• Participants with a clinically significant or unstable medical or surgical condition
• Women who are pregnant or nursing or who intend to be during the study period
• Women of child-bearing potential who do not practice an acceptable method of birth control NOTE: Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Methylprednisolone

Drug: Placebo

Drug: Prednisolone/Prednisone

Drug: Mycophenolate Mofetil

Laquinimod 0.5 mg

Experimental group

Description:

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.

Treatment:

Drug: Laquinimod

Drug: Methylprednisolone

Drug: Placebo

Drug: Prednisolone/Prednisone

Drug: Mycophenolate Mofetil

Laquinimod 1 mg

Experimental group

Description:

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.

Treatment:

Drug: Laquinimod

Drug: Methylprednisolone

Drug: Prednisolone/Prednisone

Drug: Mycophenolate Mofetil