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

This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries Identifier:
First received: March 4, 2010
Last updated: July 20, 2016
Last verified: July 2016
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.

Condition Intervention Phase
Lupus Nephritis
Drug: laquinimod
Drug: Mycophenolate Mofetil
Drug: prednisolone/prednisone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIa, 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)

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Safety, Tolerability, Effect on protein to creatinine ratio [ Time Frame: 24 weeks ]

Enrollment: 47
Study Start Date: July 2010
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: laquinimod 0.5 mg + prednisolone/prednisone
laquinimod 0.5 mg + Mycophenolate Mofetil (MMF) + prednisolone/prednisone
Drug: laquinimod
Laquinimod 0.5 mg or 1 mg
Drug: Mycophenolate Mofetil
Mycophenolate Mofetil (MMF)
Drug: prednisolone/prednisone
Experimental: laquinimod 1 mg + prednisolone/prednisone
laquinimod 1 mg + Mycophenolate Mofetil (MMF) + prednisolone/prednisone
Drug: laquinimod
Laquinimod 0.5 mg or 1 mg
Drug: Mycophenolate Mofetil
Mycophenolate Mofetil (MMF)
Drug: prednisolone/prednisone
Placebo Comparator: placebo + prednisolone/prednisone
Mycophenolate Mofetil (MMF) + prednisolone/prednisone+ placebo
Drug: Mycophenolate Mofetil
Mycophenolate Mofetil (MMF)
Drug: prednisolone/prednisone
Drug: Placebo


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01085097

  Show 31 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
Principal Investigator: David Jayne, Prof. University of Cambridge, Addenbrooke's Hospital, UK
  More Information

Responsible Party: Teva Pharmaceutical Industries Identifier: NCT01085097     History of Changes
Other Study ID Numbers: LN-LAQ-201
2010-018329-20 ( EudraCT Number )
Study First Received: March 4, 2010
Last Updated: July 20, 2016

Keywords provided by Teva Pharmaceutical Industries:
Systemic Lupus Erythematosus (SLE)
Lupus Nephritis

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
Mycophenolate mofetil
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents processed this record on May 25, 2017