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

NCT01085097 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-03-09

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, M.D. · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-01
Primary Completion
2012-10-24
Completion
2012-10-24

Countries

  • United States
  • Canada
  • France
  • Russia
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01085097 on ClinicalTrials.gov