Laquinimod Phase IIa Study in Active Crohn's Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Teva Pharmaceutical Industries

ClinicalTrials.gov Identifier:

NCT00737932

First received: August 18, 2008

Last updated: January 24, 2012

Last verified: January 2012

History of Changes

Purpose

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	Intervention	Phase
Crohn's Disease	Drug: Laquinimod Other: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	180
Study Start Date:	May 2010
Study Completion Date:	December 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737932

Show 34 Study Locations

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Principal Investigator:

Geert D'Haens, MD PhD

Imelda General Hospital

More Information

No publications provided

Responsible Party:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00737932 History of Changes
Other Study ID Numbers:	CD-LAQ-201
Study First Received:	August 18, 2008
Last Updated:	January 24, 2012
Health Authority:	European Union: European Medicines Agency

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis

Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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