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

• 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: Teva Branded Pharmaceutical Products R&D, Inc.
• Information provided by (Responsible Party): Teva Branded Pharmaceutical Products R&D, Inc.

Tracking Information

• First Submitted Date: March 4, 2010
• First Posted Date: March 11, 2010
• Results First Submitted Date: February 14, 2022
• Results First Posted Date: March 9, 2022
• Last Update Posted Date: March 9, 2022
• Actual Study Start Date: September 1, 2010
• Actual Primary Completion Date: October 24, 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: March 9, 2010): Safety, Tolerability, Effect on protein to creatinine ratio [ Time Frame: 24 weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Lupus Nephritis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 3, 2022): 46
• Original Estimated Enrollment (submitted: March 9, 2010): 45
• Actual Study Completion Date: October 24, 2012
• Actual Primary Completion Date: October 24, 2012 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, France, Russian Federation, United Kingdom, United States

Administrative Information

• NCT Number: NCT01085097
• Other Study ID Numbers: LN-LAQ-201; 2010-018329-20 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: Teva Branded Pharmaceutical Products R&D, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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