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Laquinimod Phase IIa Study in Active Crohn's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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.

NCT00737932•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (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

Key Dates

Start Date

May 1, 2010

Primary Completion Date

November 1, 2011

Completion Date

December 1, 2011

Last Updated

March 20, 2015

Enrollment

180

ACTUAL participants

Conditions

Crohn's Disease

Interventions

Laquinimod

DRUG

placebo

OTHER

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Laquinimod Phase IIa Study in Active Crohn's Disease

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

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