This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Laquinimod Phase IIa Study in Active Crohn's Disease

This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries Identifier:
First received: August 18, 2008
Last updated: March 19, 2015
Last verified: March 2015
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
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.

Resource links provided by NLM:

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 ]

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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00737932

  Show 34 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
Principal Investigator: Geert D'Haens, MD PhD Imelda General Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries Identifier: NCT00737932     History of Changes
Other Study ID Numbers: CD-LAQ-201
Study First Received: August 18, 2008
Last Updated: March 19, 2015

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on August 18, 2017