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

Teva Branded Pharmaceutical Products R&D, Inc.46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Lupus Nephritis

Interventions

LaquinimodDRUG

Laquinimod will be administered per dose and schedule specified in the arm description.

Mycophenolate MofetilDRUG

Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.

Prednisolone/PrednisoneDRUG

Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (30)

Outcomes

Primary Outcomes

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'.

Time frame: Baseline up to Week 28

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.

Time frame: Baseline, Week 24

Data from ClinicalTrials.gov

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Teva Investigational Site 1032

Phoenix, Arizona, United States

Teva Investigational Site 1024

La Jolla, California, United States

Teva Investigational Site 1028

Los Angeles, California, United States

Teva Investigational Site 1025

San Leandro, California, United States

Teva Investigational Site 1031

Baltimore, Maryland, United States

Teva Investigational Site 1021

Rochester, Minnesota, United States

Teva Investigational Site 1022

Lake Success, New York, United States

Teva Investigational Site 1018

Manhasset, New York, United States

Teva Investigational Site 1019

New York, New York, United States

Teva Investigational Site 1017

New York, New York, United States

...and 20 more locations