drugset / Trial / NCT00737932

Laquinimod Phase IIa Study in Active Crohn's Disease

NCT00737932

Phase 2 Completed 180 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2010-05
Primary completion
2011-11
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Laquinimod Small molecule 0.5 mg Oral
Subject Laquinimod Small molecule 1 mg Oral
Subject Laquinimod Small molecule 1.5 mg Oral
Subject Laquinimod Small molecule 2 mg Oral

Indications