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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085097
First Posted: March 11, 2010
Last Update Posted: July 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
  Purpose
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: Triple (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
corticosteroids
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
corticosteroids
Placebo Comparator: placebo + prednisolone/prednisone
Mycophenolate Mofetil (MMF) + prednisolone/prednisone+ placebo
Drug: Mycophenolate Mofetil
Mycophenolate Mofetil (MMF)
Drug: prednisolone/prednisone
corticosteroids
Drug: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085097


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

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01085097     History of Changes
Other Study ID Numbers: LN-LAQ-201
2010-018329-20 ( EudraCT Number )
First Submitted: March 4, 2010
First Posted: March 11, 2010
Last Update Posted: July 22, 2016
Last Verified: July 2016

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

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Nephritis
Lupus Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Prednisolone acetate
Methylprednisolone acetate
Prednisone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
Mycophenolate mofetil
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents


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