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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Laquinimod

Mycophenolate Mofetil

Prednisolone/Prednisone

Placebo

Methylprednisolone

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring Systemic Lupus Erythematosus (SLE), Lupus Nephritis, Laquinimod

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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
Women of child-bearing potential who do not practice an acceptable method of birth control NOTE: Other inclusion and exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Laquinimod 0.5 mg

Laquinimod 1 mg

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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'.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01085097

First Posted

March 4, 2010

Last Updated

February 14, 2022

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01085097

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

September 1, 2010 (Actual)

Primary Completion Date

October 24, 2012 (Actual)

Study Completion Date

October 24, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lupus Nephritis

Keywords

Systemic Lupus Erythematosus (SLE), Lupus Nephritis, Laquinimod

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Laquinimod 0.5 mg

Arm Type

Experimental

Arm Description

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.

Arm Title

Laquinimod 1 mg

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Laquinimod

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Mycophenolate Mofetil

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Prednisolone/Prednisone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs)

Description

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

Title

Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24

Description

Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula.

Time Frame

Baseline, Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teva Medical Expert, M.D.

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 1032

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85012

Country

United States

Facility Name

Teva Investigational Site 1024

City

La Jolla

State/Province

California

ZIP/Postal Code

92037-0943

Country

United States

Facility Name

Teva Investigational Site 1028

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Teva Investigational Site 1025

City

San Leandro

State/Province

California

ZIP/Postal Code

94578

Country

United States

Facility Name

Teva Investigational Site 1031

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Teva Investigational Site 1021

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Teva Investigational Site 1022

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Teva Investigational Site 1018

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

Teva Investigational Site 1019

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Teva Investigational Site 1017

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Teva Investigational Site 1020

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Teva Investigational Site 1016

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Teva Investigational Site 1030

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Teva Investigational Site 1026

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37408

Country

United States

Facility Name

Teva Investigational Site 1115

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Teva Investigational Site 1114

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M4

Country

Canada

Facility Name

Teva Investigational Site 1113

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

Teva Investigational Site 3510

City

Lille

ZIP/Postal Code

59057

Country

France

Facility Name

Teva Investigational Site 3509

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Teva Investigational Site 5006

City

Kazan

ZIP/Postal Code

420064

Country

Russian Federation

Facility Name

Teva Investigational Site 5007

City

Kemerovo

ZIP/Postal Code

650029

Country

Russian Federation

Facility Name

Teva Investigational Site 5001

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Teva Investigational Site 5003

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Teva Investigational Site 5002

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Teva Investigational Site 5005

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Teva Investigational Site 3413

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Teva Investigational Site 3409

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Teva Investigational Site 3412

City

Dudley

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

Facility Name

Teva Investigational Site 3410

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Teva Investigational Site 3411

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Lupus Nephritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial