Laquinimod Phase IIa Study in Active Crohn's Disease

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Other: placebo; Drug: Laquinimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT00737932

CD-LAQ-201

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects diagnosed with Crohn's disease for at least 3 months prior to screening.
2. Moderate to severe Crohn's disease patients as determined by the CDAI score

Exclusion criteria

1. Subjects who have had recent bowel surgery
2. Subjects with clinically significant GI obstructive symptoms
3. Subjects with a clinically significant or unstable medical or surgical condition
4. Subjects with unstable doses of standard of care medications (5-ASA, antibiotics, oral corticosteroids, immunosuppressants )
5. Women who are pregnant or nursing or who intend to be during the study period.
6. Women of child-bearing potential who do not practice an acceptable method of birth control

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Laquinimod

Experimental group

Description:

Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts)

Treatment:

Drug: Laquinimod

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Other: placebo