A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
NCT ID: NCT01085097
Last Updated: 2022-03-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2010-09-01
2012-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Mycophenolate Mofetil
Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.
Prednisolone/Prednisone
Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.
Placebo
Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Methylprednisolone
Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.
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.
Laquinimod
Laquinimod will be administered per dose and schedule specified in the arm description.
Mycophenolate Mofetil
Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.
Prednisolone/Prednisone
Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.
Placebo
Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Methylprednisolone
Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.
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.
Laquinimod
Laquinimod will be administered per dose and schedule specified in the arm description.
Mycophenolate Mofetil
Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.
Prednisolone/Prednisone
Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.
Methylprednisolone
Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.
Interventions
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Laquinimod
Laquinimod will be administered per dose and schedule specified in the arm description.
Mycophenolate Mofetil
Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.
Prednisolone/Prednisone
Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.
Placebo
Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Methylprednisolone
Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.
Eligibility Criteria
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Inclusion Criteria
* 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 a clinically significant or unstable medical or surgical condition
* Women who are pregnant or nursing or who intend to be during the study period
18 Years
75 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, M.D.
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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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
Teva Investigational Site 1020
Charlotte, North Carolina, United States
Teva Investigational Site 1016
Columbus, Ohio, United States
Teva Investigational Site 1030
Charleston, South Carolina, United States
Teva Investigational Site 1026
Chattanooga, Tennessee, United States
Teva Investigational Site 1115
Edmonton, Alberta, Canada
Teva Investigational Site 1114
Winnipeg, Manitoba, Canada
Teva Investigational Site 1113
Toronto, Ontario, Canada
Teva Investigational Site 3510
Lille, , France
Teva Investigational Site 3509
Paris, , France
Teva Investigational Site 5006
Kazan', , Russia
Teva Investigational Site 5007
Kemerovo, , Russia
Teva Investigational Site 5001
Moscow, , Russia
Teva Investigational Site 5003
Moscow, , Russia
Teva Investigational Site 5002
Moscow, , Russia
Teva Investigational Site 5005
Yaroslavl, , Russia
Teva Investigational Site 3413
Birmingham, , United Kingdom
Teva Investigational Site 3409
Cambridge, , United Kingdom
Teva Investigational Site 3412
Dudley, , United Kingdom
Teva Investigational Site 3410
London, , United Kingdom
Teva Investigational Site 3411
Manchester, , United Kingdom
Countries
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Other Identifiers
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2010-018329-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LN-LAQ-201
Identifier Type: -
Identifier Source: org_study_id
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