Laquinimod Phase IIa Study in Active Crohn's Disease

March 19, 2015 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bonheiden, Belgium
        • Teva Investigational Site 3711
      • Leuven, Belgium
        • Teva Investigational Site 3712
      • Roeselare, Belgium
        • Teva Investigational Site 3713
  • France
      • Amiens Cedex 1, France
        • Teva Investigational Site 5351
      • Clichy, France
        • Teva Investigational Site 5352
      • La Tronche, France
        • Teva Investigational Site 5353
      • Lille Cedex, France
        • Teva Investigational Site 5350
      • Nice, France
        • Teva Investigational Site 5354
      • Paris, France
        • Teva Investigational Site 5355
  • Israel
      • Haifa, Israel
        • Teva Investigational Site 8048
    • IL
      • Jerusalem, IL, Israel
        • Teva Investigational Site 8046
      • Petach-Tikva, IL, Israel
        • Teva Investigational Site 8047
      • Ramat -Gan, IL, Israel
        • Teva Investigational Site 8050
      • Rehovot, IL, Israel
        • Teva Investigational Site 8051
      • Tel-Aviv, IL, Israel
        • Teva Investigational Site 8049
  • Italy
      • Roma, Italy
        • Teva Investigational Site 3069
      • Roma, Italy
        • Teva Investigational Site 3070
      • San Donato Milanese (MI), Italy
        • Teva Investigational Site 3072
  • Netherlands
      • Amsterdam, Netherlands
        • Teva Investigational Site 3819
      • Rotterdam, Netherlands
        • Teva Investigational Site 3820
  • Poland
      • Krakow, Poland
        • Teva Investigational Site 5361
      • Warszawa, Poland
        • Teva Investigational Site 5360
      • Wroclaw, Poland
        • Teva Investigational Site 5362
      • Wroclaw, Poland
        • Teva Investigational Site 5363
  • South Africa
      • Claremont, Cape Town, South Africa
        • Teva Investigational Site 9009
      • Overport, Durban, South Africa
        • Teva Investigational Site 9017
      • Panorama, Cape Town, South Africa
        • Teva Investigational Site 9013
  • Spain
      • Barcelona, Spain
        • Teva Investigational Site 3158
      • Córdoba, Spain
        • Teva Investigational Site 3164
      • Madrid, Spain
        • Teva Investigational Site 3160
  • United Kingdom
      • Bristol, United Kingdom
        • Teva Investigational Site 3428
      • Coventry, United Kingdom
        • Teva Investigational Site 3430
      • Liverpool, United Kingdom
        • Teva Investigational Site 3429
      • London, United Kingdom
        • Teva Investigational Site 3432

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Matching placebo
Other: placebo
Matching placebo for 8 weeks of 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Principal Investigator: Geert D'Haens, MD PhD, Imelda General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (ESTIMATE)

August 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-LAQ-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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