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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01085097
First received: March 4, 2010
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  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 0.5mg + standard of care
Drug: laquinimod 1mg + standard of care
Other: placebo + standard of care
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Lupus Steroids
U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Safety, Tolerability, Effect on protein to creatinine ratio [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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 0.5mg
Mycophenolate Mofetil (MMF) + corticosteroids + laquinimod 0.5 mg
 Drug: laquinimod 0.5mg + standard of care
Laquinimod 0.5mg administered in addition to Mycophenolate Mofetil (MMF) + corticosteroids
Experimental: laquinimod 1mg
Mycophenolate Mofetil (MMF) + corticosteroids + laquinimod 1mg
 Drug: laquinimod 1mg + standard of care
Laquinimod 1mg administered in addition to Mycophenolate Mofetil (MMF) + corticosteroids
Placebo Comparator: placebo
Mycophenolate Mofetil (MMF) + corticosteroids + placebo
 Other: placebo + standard of care
Placebo administered in addition to Mycophenolate Mofetil (MMF) + corticosteroids

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01085097     History of Changes
Other Study ID Numbers: LN-LAQ-201, 2010-018329-20
Study First Received: March 4, 2010
Last Updated: January 9, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Nephritis
Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Mycophenolate mofetil
 Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013