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NCT00737932 Clinical Trial

Laquinimod Phase IIa Study in Active Crohn's Disease

Crohn's Disease Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00737932
Other study ID # CD-LAQ-201
Secondary ID
Status Completed
Phase Phase 2
First received August 18, 2008
Last updated March 19, 2015
Start date May 2010
Est. completion date December 2011

Study information
Verified date March 2015
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date December 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium Teva Investigational Site 3711 Bonheiden
Belgium Teva Investigational Site 3712 Leuven
Belgium Teva Investigational Site 3713 Roeselare
France Teva Investigational Site 5351 Amiens Cedex 1
France Teva Investigational Site 5352 Clichy
France Teva Investigational Site 5353 La Tronche
France Teva Investigational Site 5350 Lille Cedex
France Teva Investigational Site 5354 Nice
France Teva Investigational Site 5355 Paris
Israel Teva Investigational Site 8048 Haifa
Israel 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 8049 Tel-Aviv IL
Italy Teva Investigational Site 3069 Roma
Italy Teva Investigational Site 3070 Roma
Italy Teva Investigational Site 3072 San Donato Milanese (MI)
Netherlands Teva Investigational Site 3819 Amsterdam
Netherlands Teva Investigational Site 3820 Rotterdam
Poland Teva Investigational Site 5361 Krakow
Poland Teva Investigational Site 5360 Warszawa
Poland Teva Investigational Site 5362 Wroclaw
Poland Teva Investigational Site 5363 Wroclaw
South Africa Teva Investigational Site 9009 Claremont, Cape Town
South Africa Teva Investigational Site 9017 Overport, Durban
South Africa Teva Investigational Site 9013 Panorama, Cape Town
Spain Teva Investigational Site 3158 Barcelona
Spain Teva Investigational Site 3164 Córdoba
Spain Teva Investigational Site 3160 Madrid
United Kingdom Teva Investigational Site 3428 Bristol
United Kingdom Teva Investigational Site 3430 Coventry
United Kingdom Teva Investigational Site 3429 Liverpool
United Kingdom Teva Investigational Site 3432 London

Sponsors (1)
Lead Sponsor Collaborator
Teva Pharmaceutical Industries

Countries where clinical trial is conducted

Belgium,  France,  Israel,  Italy,  Netherlands,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment. 8 weeks No
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