Laquinimod Phase IIa Study in Active Crohn's Disease

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Other: placebo; Drug: Laquinimod

• Registration Number: NCT00737932
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Study Start: 2010-05
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Matching placebo
Laquinimod	Laquinimod	Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts)

Primary Outcome Measures

Name	Time	Method
Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment.	8 weeks

Trial Locations

Locations (34)

Teva Investigational Site 5354; 🇫🇷 Nice, France

Teva Investigational Site 5355; 🇫🇷 Paris, France

Teva Investigational Site 3711; 🇧🇪 Bonheiden, Belgium

Teva Investigational Site 3712; 🇧🇪 Leuven, Belgium

Teva Investigational Site 3713; 🇧🇪 Roeselare, Belgium

Teva Investigational Site 5352; 🇫🇷 Clichy, France

Teva Investigational Site 5351; 🇫🇷 Amiens Cedex 1, France

Teva Investigational Site 5353; 🇫🇷 La Tronche, France

Teva Investigational Site 5350; 🇫🇷 Lille Cedex, France

Teva Investigational Site 8046; 🇮🇱 Jerusalem, IL, Israel

Teva Investigational Site 8047; 🇮🇱 Petach-Tikva, IL, Israel

Teva Investigational Site 8050; 🇮🇱 Ramat -Gan, IL, Israel

Teva Investigational Site 8051; 🇮🇱 Rehovot, IL, Israel

Teva Investigational Site 3070; 🇮🇹 Roma, Italy

Teva Investigational Site 8049; 🇮🇱 Tel-Aviv, IL, Israel

Teva Investigational Site 3069; 🇮🇹 Roma, Italy

Teva Investigational Site 8048; 🇮🇱 Haifa, Israel

Teva Investigational Site 3072; 🇮🇹 San Donato Milanese (MI), Italy

Teva Investigational Site 3820; 🇳🇱 Rotterdam, Netherlands

Teva Investigational Site 3819; 🇳🇱 Amsterdam, Netherlands

Teva Investigational Site 5361; 🇵🇱 Krakow, Poland

Teva Investigational Site 5360; 🇵🇱 Warszawa, Poland

Teva Investigational Site 5362; 🇵🇱 Wroclaw, Poland

Teva Investigational Site 9009; 🇿🇦 Claremont, Cape Town, South Africa

Teva Investigational Site 5363; 🇵🇱 Wroclaw, Poland

Teva Investigational Site 9013; 🇿🇦 Panorama, Cape Town, South Africa

Teva Investigational Site 9017; 🇿🇦 Overport, Durban, South Africa

Teva Investigational Site 3164; 🇪🇸 Córdoba, Spain

Teva Investigational Site 3160; 🇪🇸 Madrid, Spain

Teva Investigational Site 3158; 🇪🇸 Barcelona, Spain

Teva Investigational Site 3428; 🇬🇧 Bristol, United Kingdom

Teva Investigational Site 3430; 🇬🇧 Coventry, United Kingdom

Teva Investigational Site 3432; 🇬🇧 London, United Kingdom

Teva Investigational Site 3429; 🇬🇧 Liverpool, United Kingdom