Laquinimod Phase IIa Study in Active Crohn's Disease

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00737932

Collaborator

(none)

180

Enrollment

Locations

Arms

Duration (Months)

5.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease	Drug: Laquinimod Other: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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.

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laquinimod Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts)	Drug: Laquinimod Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment
Placebo Comparator: Placebo Matching placebo	Other: placebo Matching placebo for 8 weeks of treatment

Arm

Intervention/Treatment

Experimental: Laquinimod

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

Drug: Laquinimod

Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment

Placebo Comparator: Placebo

Matching placebo

Other: placebo

Matching placebo for 8 weeks of treatment

Outcome Measures

Primary Outcome Measures

Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment. [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Teva Investigational Site 3711	Bonheiden		Belgium
2	Teva Investigational Site 3712	Leuven		Belgium
3	Teva Investigational Site 3713	Roeselare		Belgium
4	Teva Investigational Site 5351	Amiens Cedex 1		France
5	Teva Investigational Site 5352	Clichy		France
6	Teva Investigational Site 5353	La Tronche		France
7	Teva Investigational Site 5350	Lille Cedex		France
8	Teva Investigational Site 5354	Nice		France
9	Teva Investigational Site 5355	Paris		France
10	Teva Investigational Site 8046	Jerusalem	IL	Israel
11	Teva Investigational Site 8047	Petach-Tikva	IL	Israel
12	Teva Investigational Site 8050	Ramat -Gan	IL	Israel
13	Teva Investigational Site 8051	Rehovot	IL	Israel
14	Teva Investigational Site 8049	Tel-Aviv	IL	Israel
15	Teva Investigational Site 8048	Haifa		Israel
16	Teva Investigational Site 3069	Roma		Italy
17	Teva Investigational Site 3070	Roma		Italy
18	Teva Investigational Site 3072	San Donato Milanese (MI)		Italy
19	Teva Investigational Site 3819	Amsterdam		Netherlands
20	Teva Investigational Site 3820	Rotterdam		Netherlands
21	Teva Investigational Site 5361	Krakow		Poland
22	Teva Investigational Site 5360	Warszawa		Poland
23	Teva Investigational Site 5362	Wroclaw		Poland
24	Teva Investigational Site 5363	Wroclaw		Poland
25	Teva Investigational Site 9009	Claremont, Cape Town		South Africa
26	Teva Investigational Site 9017	Overport, Durban		South Africa
27	Teva Investigational Site 9013	Panorama, Cape Town		South Africa
28	Teva Investigational Site 3158	Barcelona		Spain
29	Teva Investigational Site 3164	Córdoba		Spain
30	Teva Investigational Site 3160	Madrid		Spain
31	Teva Investigational Site 3428	Bristol		United Kingdom
32	Teva Investigational Site 3430	Coventry		United Kingdom
33	Teva Investigational Site 3429	Liverpool		United Kingdom
34	Teva Investigational Site 3432	London		United Kingdom

Sponsors and Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

Principal Investigator: Geert D'Haens, MD PhD, Imelda General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Teva Branded Pharmaceutical Products R&D, Inc.

ClinicalTrials.gov Identifier:

NCT00737932

Other Study ID Numbers:

CD-LAQ-201

First Posted:

Aug 20, 2008

Last Update Posted:

Mar 20, 2015

Last Verified:

Mar 1, 2015

Additional relevant MeSH terms:

Crohn Disease

Study Results

No Results Posted as of Mar 20, 2015