Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Nephritis - Full Text View

Sponsor:	Teva Pharmaceutical Industries
Information provided by (Responsible Party):	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT01085097

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

Drug Information available for: Mycophenolate mofetil hydrochloride Mycophenolate mofetil

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 ]

Estimated Enrollment:	45
Study Start Date:	July 2010
Estimated Study Completion Date:	October 2012
Estimated 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:

Subjects diagnosed with SLE
Kidney biopsy within 12 months prior to baseline with a histological diagnosis of proliferative or membranous Lupus Nephritis
Clinically active Lupus Nephritis as evident by urine protein to creatinine ratio

Exclusion Criteria:

Subjects with severe renal impairment or dialysis
Subjects 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

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:	May 17, 2012
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 23, 2012