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

NCT01085097 | Completed Phase 2 Results

• 2 other identifiers: LN-LAQ-2012010-018329-20
• Study Type: interventional
• Target: 46
• Locations: 5 countries
• Sites: 30

Brief 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.

Conditions

Lupus Nephritis

Keywords

Systemic Lupus Erythematosus (SLE); Lupus Nephritis; Laquinimod

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive 2 capsules of placebo matching to laquinimod orally once daily (QD) for 24 weeks, MMF 500 mg tablet orally twice daily (BID) for the first week then 1 gram (g) BID from Week 2 to Week 28, and MP 500 mg/day intravenously (IV) from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.

Drug: Mycophenolate Mofetil; Drug: Prednisolone/Prednisone; Drug: Placebo; Drug: Methylprednisolone

Laquinimod 0.5 mg

EXPERIMENTAL

Participants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matching to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.

Drug: Laquinimod; Drug: Mycophenolate Mofetil; Drug: Prednisolone/Prednisone; Drug: Placebo; Drug: Methylprednisolone

Laquinimod 1 mg

EXPERIMENTAL

Participants will receive 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.

Drug: Laquinimod; Drug: Mycophenolate Mofetil; Drug: Prednisolone/Prednisone; Drug: Methylprednisolone

Interventions

Laquinimod DRUG

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

Laquinimod 0.5 mg; Laquinimod 1 mg

Mycophenolate Mofetil DRUG

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

Laquinimod 0.5 mg; Laquinimod 1 mg; Placebo

Prednisolone/Prednisone DRUG

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

Laquinimod 0.5 mg; Laquinimod 1 mg; Placebo

Placebo DRUG

Placebo matching to laquinimod will be administered per schedule specified in the arm description.

Laquinimod 0.5 mg; Placebo

Methylprednisolone DRUG

Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.

Laquinimod 0.5 mg; Laquinimod 1 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (30)

Teva Investigational Site 1032

Phoenix, Arizona, 85012, United States

Location

Teva Investigational Site 1024

La Jolla, California, 92037-0943, United States

Location

Teva Investigational Site 1028

Los Angeles, California, 90048, United States

Location

Teva Investigational Site 1025

San Leandro, California, 94578, United States

Location

Teva Investigational Site 1031

Baltimore, Maryland, 21205, United States

Location

Teva Investigational Site 1021

Rochester, Minnesota, 55905, United States

Location

Teva Investigational Site 1022

Lake Success, New York, 11042, United States

Location

Teva Investigational Site 1018

Manhasset, New York, 11030, United States

Location

Teva Investigational Site 1019

New York, New York, 10016, United States

Location

Teva Investigational Site 1017

New York, New York, 10032, United States

Location

Teva Investigational Site 1020

Charlotte, North Carolina, 28210, United States

Location

Teva Investigational Site 1016

Columbus, Ohio, 43210, United States

Location

Teva Investigational Site 1030

Charleston, South Carolina, 29425, United States

Location

Teva Investigational Site 1026

Chattanooga, Tennessee, 37408, United States

Location

Teva Investigational Site 1115

Edmonton, Alberta, T6G 2B7, Canada

Location

Teva Investigational Site 1114

Winnipeg, Manitoba, R3A 1M4, Canada

Location

Teva Investigational Site 1113

Toronto, Ontario, M5T 2S8, Canada

Location

Teva Investigational Site 3510

Lille, 59057, France

Location

Teva Investigational Site 3509

Paris, 75013, France

Location

Teva Investigational Site 5006

Kazan', 420064, Russia

Location

Teva Investigational Site 5007

Kemerovo, 650029, Russia

Location

Teva Investigational Site 5001

Moscow, 115522, Russia

Location

Teva Investigational Site 5003

Moscow, 123182, Russia

Location

Teva Investigational Site 5002

Moscow, 125284, Russia

Location

Teva Investigational Site 5005

Yaroslavl, 150062, Russia

Location

Teva Investigational Site 3413

Birmingham, B15 2TH, United Kingdom

Location

Teva Investigational Site 3409

Cambridge, CB2 0QQ, United Kingdom

Location

Teva Investigational Site 3412

Dudley, DY1 2HQ, United Kingdom

Location

Teva Investigational Site 3410

London, SE1 7EH, United Kingdom

Location

Teva Investigational Site 3411

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Interventions

laquinimod; Mycophenolic Acid; Prednisolone; Prednisone; Methylprednisolone

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D, Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Teva Medical Expert, M.D.

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 11, 2010
• Study Start: September 1, 2010
• Primary Completion: October 24, 2012
• Study Completion: October 24, 2012
• Last Updated: March 9, 2022
• Results First Posted: March 9, 2022

Record last verified: 2022-02

Locations

RU (6); CA (3); FR (2); US (14); GB (5)