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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laquinimod | Experimental | Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts) |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laquinimod | Drug | Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geert D'Haens, MD PhD | Imelda General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 3711 | Bonheiden | Belgium | ||||
| Teva Investigational Site 3712 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25281416 | Derived | D'Haens G, Sandborn WJ, Colombel JF, Rutgeerts P, Brown K, Barkay H, Sakov A, Haviv A, Feagan BG; Laquinimod for Crohn's Disease Investigators. A phase II study of laquinimod in Crohn's disease. Gut. 2015 Aug;64(8):1227-35. doi: 10.1136/gutjnl-2014-307118. Epub 2014 Oct 3. |
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| placebo | Other | Matching placebo for 8 weeks of treatment |
|
| 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 |
| Teva Investigational Site 8047 | Petah 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 | Israel |
| Teva Investigational Site 8048 | Haifa | Israel |
| Teva Investigational Site 3069 | Roma | Italy |
| Teva Investigational Site 3070 | Roma | Italy |
| Teva Investigational Site 3072 | San Donato Milanese (MI) | Italy |
| Teva Investigational Site 3819 | Amsterdam | Netherlands |
| Teva Investigational Site 3820 | Rotterdam | Netherlands |
| Teva Investigational Site 5361 | Krakow | Poland |
| Teva Investigational Site 5360 | Warsaw | Poland |
| Teva Investigational Site 5362 | Wroclaw | Poland |
| Teva Investigational Site 5363 | Wroclaw | Poland |
| Teva Investigational Site 9009 | Claremont, Cape Town | South Africa |
| Teva Investigational Site 9017 | Overport, Durban | South Africa |
| Teva Investigational Site 9013 | Panorama, Cape Town | South Africa |
| Teva Investigational Site 3158 | Barcelona | Spain |
| Teva Investigational Site 3164 | Córdoba | Spain |
| Teva Investigational Site 3160 | Madrid | Spain |
| 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 | United Kingdom |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C476223 | laquinimod |
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