Clinical trial NCT00737932: Laquinimod Phase IIa Study in Active Crohn's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Teva Investigational Site 3711
city: Leuven
country: Belgium
facility: Teva Investigational Site 3712
city: Roeselare
country: Belgium
facility: Teva Investigational Site 3713
city: Amiens Cedex 1
country: France
facility: Teva Investigational Site 5351
city: Clichy
country: France
facility: Teva Investigational Site 5352
city: La Tronche
country: France
facility: Teva Investigational Site 5353
city: Lille Cedex
country: France
facility: Teva Investigational Site 5350
city: Nice
country: France
facility: Teva Investigational Site 5354
city: Paris
country: France
facility: Teva Investigational Site 5355
city: Jerusalem
country: Israel
facility: Teva Investigational Site 8046
state: IL
city: Petach-Tikva
country: Israel
facility: Teva Investigational Site 8047
state: IL
city: Ramat -Gan
country: Israel
facility: Teva Investigational Site 8050
state: IL
city: Rehovot
country: Israel
facility: Teva Investigational Site 8051
state: IL
city: Tel-Aviv
country: Israel
facility: Teva Investigational Site 8049
state: IL
city: Haifa
country: Israel
facility: Teva Investigational Site 8048
city: Roma
country: Italy
facility: Teva Investigational Site 3069
city: Roma
country: Italy
facility: Teva Investigational Site 3070
city: San Donato Milanese (MI)
country: Italy
facility: Teva Investigational Site 3072
city: Amsterdam
country: Netherlands
facility: Teva Investigational Site 3819
city: Rotterdam
country: Netherlands
facility: Teva Investigational Site 3820
city: Krakow
country: Poland
facility: Teva Investigational Site 5361
city: Warszawa
country: Poland
facility: Teva Investigational Site 5360
city: Wroclaw
country: Poland
facility: Teva Investigational Site 5362
city: Wroclaw
country: Poland
facility: Teva Investigational Site 5363
city: Claremont, Cape Town
country: South Africa
facility: Teva Investigational Site 9009
city: Overport, Durban
country: South Africa
facility: Teva Investigational Site 9017
city: Panorama, Cape Town
country: South Africa
facility: Teva Investigational Site 9013
city: Barcelona
country: Spain
facility: Teva Investigational Site 3158
city: Córdoba
country: Spain
facility: Teva Investigational Site 3164
city: Madrid
country: Spain
facility: Teva Investigational Site 3160
city: Bristol
country: United Kingdom
facility: Teva Investigational Site 3428
city: Coventry
country: United Kingdom
facility: Teva Investigational Site 3430
city: Liverpool
country: United Kingdom
facility: Teva Investigational Site 3429
city: London
country: United Kingdom
facility: Teva Investigational Site 3432
Study officials:
affiliation: Imelda General Hospital
name: Geert D'Haens, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.