CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Laquinimod +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01085097
NCT01085097Phase 2Completed
CompareCT.gov

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)

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Mar 11, 2010·Updated Mar 9, 2022

In Brief

A Phase 2 clinical trial evaluating Laquinimod, Mycophenolate Mofetil, and 3 other interventions for Lupus Nephritis. Completed, enrolled 46 participants across 30 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Nephritis
CountriesCanada, France, Russia, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2010
Enrollment StartSep 1, 2010
Primary CompletionOct 24, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.3 years ago

Interventions

Laquinimoddrug

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

Mycophenolate Mofetildrug

Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.

Prednisolone/Prednisonedrug

Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.

Placebodrug

Placebo matching to laquinimod will be administered per schedule specified in the arm description.

Methylprednisolonedrug

Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.