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A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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)

NCT01085097•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (30)

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

Key Dates

Start Date

September 1, 2010

Primary Completion Date

October 24, 2012

Completion Date

October 24, 2012

Last Updated

March 9, 2022

Enrollment

ACTUAL participants

Conditions

Lupus Nephritis

Interventions

Laquinimod

DRUG

Mycophenolate Mofetil

DRUG

Prednisolone/Prednisone

DRUG

Placebo

DRUG

Methylprednisolone

DRUG

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

NCT05126277

Lupus Nephritis

View study

RECRUITINGPHASE2

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

NCT07015983

Lupus Erythematosus, SystemicLupus Nephritis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

Safety and Efficacy of ONT01 in Lupus

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

Lupus Landmark Study: A Prospective Registry and Biorepository