Laquinimod Phase IIa Study in Active Crohn's Disease
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.
1 other identifier
interventional
180
9 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2010
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2008
CompletedFirst Posted
Study publicly available on registry
August 20, 2008
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 20, 2015
March 1, 2015
1.5 years
August 18, 2008
March 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment.
8 weeks
Study Arms (2)
Laquinimod
EXPERIMENTALLaquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts)
Placebo
PLACEBO COMPARATORMatching placebo
Interventions
Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Teva Investigational Site 3711
Bonheiden, Belgium
Teva Investigational Site 3712
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
Related Publications (1)
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.
PMID: 25281416DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geert D'Haens, MD PhD
Imelda General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2008
First Posted
August 20, 2008
Study Start
May 1, 2010
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
March 20, 2015
Record last verified: 2015-03