Laquinimod Phase IIa Study in Active Crohn's Disease

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Teva Investigational Site 3711, Bonheiden, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laquinimod

Drug

Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment

Placebo

Other

Matching placebo for 8 weeks of treatment

Primary outcomes

Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment.

Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Aug 20, 2008
Registry last updated: Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed