Phase 2
N=46
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
Lupus Nephritis
Bottom Line
View on ClinicalTrials.gov: NCT01085097 ↗Enrolled (actual)
46
Serious AEs
26.1%
Results posted
Mar 2022
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 14; 15; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laquinimod (Drug); Mycophenolate Mofetil (Drug); Prednisolone/Prednisone (Drug); Placebo (Drug); Methylprednisolone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
14; 15; 15 | — |
| PRIMARY Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24 |
12.1; 18.0; 24.3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01085097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.