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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01085097
Recruitment Status : Completed
First Posted : March 11, 2010
Results First Posted : March 9, 2022
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

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.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Laquinimod Drug: Mycophenolate Mofetil Drug: Prednisolone/Prednisone Drug: Placebo Drug: Methylprednisolone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 1, 2010
Actual Primary Completion Date : October 24, 2012
Actual Study Completion Date : October 24, 2012


Arm Intervention/treatment
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: Laquinimod
Laquinimod will be administered per dose and schedule specified in the arm description.

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

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.




Primary Outcome Measures :
  1. 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'.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085097


Locations
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Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Director: Teva Medical Expert, M.D. Teva Branded Pharmaceutical Products R&D, Inc.
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT01085097    
Other Study ID Numbers: LN-LAQ-201
2010-018329-20 ( EudraCT Number )
First Posted: March 11, 2010    Key Record Dates
Results First Posted: March 9, 2022
Last Update Posted: March 9, 2022
Last Verified: February 2022
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.:
Systemic Lupus Erythematosus (SLE)
Lupus Nephritis
Laquinimod
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Mycophenolic Acid
Prednisone
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents