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Laquinimod Phase IIa Study in Active Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00737932
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : March 20, 2015
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

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

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Study Type : Interventional  (Clinical Trial)
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 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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

Primary Outcome Measures :
  1. Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment. [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00737932

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Sponsors and Collaborators
Teva Pharmaceutical Industries
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Principal Investigator: Geert D'Haens, MD PhD Imelda General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Teva Pharmaceutical Industries Identifier: NCT00737932    
Other Study ID Numbers: CD-LAQ-201
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases