NCT01085084

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

A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients With Active Lupus Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules (0.5 milligrams \[mg\] and 1 mg) in participants with active lupus arthritis. Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.

Conditions

• Lupus Arthritis

Interventions

Type	Name	Description
DRUG	Laquinimod	Laquinimod 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.

Timeline

• Start date: 2010-10-04
• Primary completion: 2012-11-12
• Completion: 2012-11-12
• First posted: 2010-03-11
• Last updated: 2022-07-07
• Results posted: 2022-07-07

Locations

22 sites across 2 countries: United States, Canada