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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.

Tracking Information
First Submitted Date  ICMJE March 4, 2010
First Posted Date  ICMJE March 11, 2010
Results First Submitted Date  ICMJE February 14, 2022
Results First Posted Date  ICMJE March 9, 2022
Last Update Posted Date March 9, 2022
Actual Study Start Date  ICMJE September 1, 2010
Actual Primary Completion Date October 24, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2022)
  • 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'.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
Safety, Tolerability, Effect on protein to creatinine ratio [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lupus Nephritis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Mycophenolate Mofetil
    • Drug: Prednisolone/Prednisone
    • Drug: Placebo
    • Drug: Methylprednisolone
  • 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.
    Interventions:
    • Drug: Laquinimod
    • Drug: Mycophenolate Mofetil
    • Drug: Prednisolone/Prednisone
    • Drug: Placebo
    • Drug: Methylprednisolone
  • 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.
    Interventions:
    • Drug: Laquinimod
    • Drug: Mycophenolate Mofetil
    • Drug: Prednisolone/Prednisone
    • Drug: Methylprednisolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2022)
46
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2010)
45
Actual Study Completion Date  ICMJE October 24, 2012
Actual Primary Completion Date October 24, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Russian Federation,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01085097
Other Study ID Numbers  ICMJE LN-LAQ-201
2010-018329-20 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Teva Branded Pharmaceutical Products R&D, Inc.
Original Responsible Party Siyu Liu, M.D., Ph.D., Vice President, Innovative Research & Development and Head of Global Clinical Operations, Teva Branded Pharmaceutical Products R&D
Current Study Sponsor  ICMJE Teva Branded Pharmaceutical Products R&D, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Teva Medical Expert, M.D. Teva Branded Pharmaceutical Products R&D, Inc.
PRS Account Teva Branded Pharmaceutical Products R&D, Inc.
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP