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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment
Matching placebo for 8 weeks of treatment
Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment.
Time frame: 8 weeks
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Teva Investigational Site 3711
Bonheiden, Belgium
Teva Investigational Site 3712
Leuven, Belgium
Teva Investigational Site 3713
Roeselare, Belgium
Teva Investigational Site 5351
Amiens, France
Teva Investigational Site 5352
Clichy, France
Teva Investigational Site 5353
La Tronche, France
Teva Investigational Site 5350
Lille, France
Teva Investigational Site 5354
Nice, France
Teva Investigational Site 5355
Paris, France
Teva Investigational Site 8046
Jerusalem, IL, Israel
...and 24 more locations