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

February 14, 2022 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Teva Investigational Site 1115
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M4
        • Teva Investigational Site 1114
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Teva Investigational Site 1113
  • France
      • Lille, France, 59057
        • Teva Investigational Site 3510
      • Paris, France, 75013
        • Teva Investigational Site 3509
  • Russian Federation
      • Kazan, Russian Federation, 420064
        • Teva Investigational Site 5006
      • Kemerovo, Russian Federation, 650029
        • Teva Investigational Site 5007
      • Moscow, Russian Federation, 115522
        • Teva Investigational Site 5001
      • Moscow, Russian Federation, 123182
        • Teva Investigational Site 5003
      • Moscow, Russian Federation, 125284
        • Teva Investigational Site 5002
      • Yaroslavl, Russian Federation, 150062
        • Teva Investigational Site 5005
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Teva Investigational Site 3413
      • Cambridge, United Kingdom, CB2 0QQ
        • Teva Investigational Site 3409
      • Dudley, United Kingdom, DY1 2HQ
        • Teva Investigational Site 3412
      • London, United Kingdom, SE1 7EH
        • Teva Investigational Site 3410
      • Manchester, United Kingdom, M13 9WL
        • Teva Investigational Site 3411
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Teva Investigational Site 1032
    • California
      • La Jolla, California, United States, 92037-0943
        • Teva Investigational Site 1024
      • Los Angeles, California, United States, 90048
        • Teva Investigational Site 1028
      • San Leandro, California, United States, 94578
        • Teva Investigational Site 1025
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Teva Investigational Site 1031
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Teva Investigational Site 1021
    • New York
      • Lake Success, New York, United States, 11042
        • Teva Investigational Site 1022
      • Manhasset, New York, United States, 11030
        • Teva Investigational Site 1018
      • New York, New York, United States, 10016
        • Teva Investigational Site 1019
      • New York, New York, United States, 10032
        • Teva Investigational Site 1017
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Teva Investigational Site 1020
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Teva Investigational Site 1016
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Teva Investigational Site 1030
    • Tennessee
      • Chattanooga, Tennessee, United States, 37408
        • Teva Investigational Site 1026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
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
Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.
Drug: Prednisolone/Prednisone
Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.
Drug: Placebo
Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Drug: Methylprednisolone
Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.
Experimental: Laquinimod 0.5 mg
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: Mycophenolate Mofetil
Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.
Drug: Prednisolone/Prednisone
Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.
Drug: Placebo
Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Drug: Methylprednisolone
Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.
Drug: Laquinimod
Laquinimod will be administered per dose and schedule specified in the arm description.
Experimental: Laquinimod 1 mg
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: Mycophenolate Mofetil
Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.
Drug: Prednisolone/Prednisone
Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.
Drug: Methylprednisolone
Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.
Drug: Laquinimod
Laquinimod will be administered per dose and schedule specified in the arm description.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: Baseline up to Week 28
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
Time Frame: Baseline, Week 24
Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 24, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LN-LAQ-201
  • 2010-018329-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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