NCT00737932

Laquinimod Phase IIa Study in Active Crohn's Disease

A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn's Disease.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (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 of Laquinimod capsules in active moderate to severe Crohn's disease. This study will assess Laquinimod doses of 0.5mg /day to 2 mg/day in sequential dose groups (cohorts). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Laquinimod	Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment
OTHER	placebo	Matching placebo for 8 weeks of treatment

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2008-08-20
• Last updated: 2015-03-20

Locations

34 sites across 9 countries: Belgium, France, Israel, Italy, Netherlands, Poland, South Africa, Spain, United Kingdom