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

Lupus Nephritis Clinical Trial

Official title:

A Phase 2a, 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085097
• Other study ID #: LN-LAQ-201
• Secondary ID: 2010-018329-20
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2010
• Est. completion date: October 24, 2012

Study information

• Verified date: February 2022
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 24, 2012
• Est. primary completion date: October 24, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Laquinimod
Laquinimod will be administered per dose and schedule specified in the arm description.
• Mycophenolate Mofetil
Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.
• Prednisolone/Prednisone
Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.
• Placebo
Placebo matching to laquinimod will be administered per schedule specified in the arm description.
• Methylprednisolone
Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.

Locations

Country	Name	City	State
Canada	Teva Investigational Site 1115	Edmonton	Alberta
Canada	Teva Investigational Site 1113	Toronto	Ontario
Canada	Teva Investigational Site 1114	Winnipeg	Manitoba
France	Teva Investigational Site 3510	Lille
France	Teva Investigational Site 3509	Paris
Russian Federation	Teva Investigational Site 5006	Kazan
Russian Federation	Teva Investigational Site 5007	Kemerovo
Russian Federation	Teva Investigational Site 5001	Moscow
Russian Federation	Teva Investigational Site 5002	Moscow
Russian Federation	Teva Investigational Site 5003	Moscow
Russian Federation	Teva Investigational Site 5005	Yaroslavl
United Kingdom	Teva Investigational Site 3413	Birmingham
United Kingdom	Teva Investigational Site 3409	Cambridge
United Kingdom	Teva Investigational Site 3412	Dudley
United Kingdom	Teva Investigational Site 3410	London
United Kingdom	Teva Investigational Site 3411	Manchester
United States	Teva Investigational Site 1031	Baltimore	Maryland
United States	Teva Investigational Site 1030	Charleston	South Carolina
United States	Teva Investigational Site 1020	Charlotte	North Carolina
United States	Teva Investigational Site 1026	Chattanooga	Tennessee
United States	Teva Investigational Site 1016	Columbus	Ohio
United States	Teva Investigational Site 1024	La Jolla	California
United States	Teva Investigational Site 1022	Lake Success	New York
United States	Teva Investigational Site 1028	Los Angeles	California
United States	Teva Investigational Site 1018	Manhasset	New York
United States	Teva Investigational Site 1017	New York	New York
United States	Teva Investigational Site 1019	New York	New York
United States	Teva Investigational Site 1032	Phoenix	Arizona
United States	Teva Investigational Site 1021	Rochester	Minnesota
United States	Teva Investigational Site 1025	San Leandro	California

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.	Baseline up to Week 28
Primary	Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24	Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula.	Baseline, Week 24