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Laquinimod Phase IIa Study in Active Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Laquinimod
placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Teva Investigational Site 3711
  • Teva Investigational Site 3712
  • Teva Investigational Site 3713
  • Teva Investigational Site 5351
  • Teva Investigational Site 5352
  • Teva Investigational Site 5353
  • Teva Investigational Site 5350
  • Teva Investigational Site 5354
  • Teva Investigational Site 5355
  • Teva Investigational Site 8046
  • Teva Investigational Site 8047
  • Teva Investigational Site 8050
  • Teva Investigational Site 8051
  • Teva Investigational Site 8049
  • Teva Investigational Site 8048
  • Teva Investigational Site 3069
  • Teva Investigational Site 3070
  • Teva Investigational Site 3072
  • Teva Investigational Site 3819
  • Teva Investigational Site 3820
  • Teva Investigational Site 5361
  • Teva Investigational Site 5360
  • Teva Investigational Site 5362
  • Teva Investigational Site 5363
  • Teva Investigational Site 9009
  • Teva Investigational Site 9017
  • Teva Investigational Site 9013
  • Teva Investigational Site 3158
  • Teva Investigational Site 3164
  • Teva Investigational Site 3160
  • Teva Investigational Site 3428
  • Teva Investigational Site 3430
  • Teva Investigational Site 3429
  • Teva Investigational Site 3432

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Laquinimod

Placebo

Arm Description

Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts)

Matching placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 18, 2008
Last Updated
March 19, 2015
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00737932
Brief Title
Laquinimod Phase IIa Study in Active Crohn's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laquinimod
Arm Type
Experimental
Arm Description
Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Laquinimod
Intervention Description
Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Matching placebo for 8 weeks of treatment
Primary Outcome Measure Information:
Title
Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert D'Haens, MD PhD
Organizational Affiliation
Imelda General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teva Investigational Site 3711
City
Bonheiden
Country
Belgium
Facility Name
Teva Investigational Site 3712
City
Leuven
Country
Belgium
Facility Name
Teva Investigational Site 3713
City
Roeselare
Country
Belgium
Facility Name
Teva Investigational Site 5351
City
Amiens Cedex 1
Country
France
Facility Name
Teva Investigational Site 5352
City
Clichy
Country
France
Facility Name
Teva Investigational Site 5353
City
La Tronche
Country
France
Facility Name
Teva Investigational Site 5350
City
Lille Cedex
Country
France
Facility Name
Teva Investigational Site 5354
City
Nice
Country
France
Facility Name
Teva Investigational Site 5355
City
Paris
Country
France
Facility Name
Teva Investigational Site 8046
City
Jerusalem
State/Province
IL
Country
Israel
Facility Name
Teva Investigational Site 8047
City
Petach-Tikva
State/Province
IL
Country
Israel
Facility Name
Teva Investigational Site 8050
City
Ramat -Gan
State/Province
IL
Country
Israel
Facility Name
Teva Investigational Site 8051
City
Rehovot
State/Province
IL
Country
Israel
Facility Name
Teva Investigational Site 8049
City
Tel-Aviv
State/Province
IL
Country
Israel
Facility Name
Teva Investigational Site 8048
City
Haifa
Country
Israel
Facility Name
Teva Investigational Site 3069
City
Roma
Country
Italy
Facility Name
Teva Investigational Site 3070
City
Roma
Country
Italy
Facility Name
Teva Investigational Site 3072
City
San Donato Milanese (MI)
Country
Italy
Facility Name
Teva Investigational Site 3819
City
Amsterdam
Country
Netherlands
Facility Name
Teva Investigational Site 3820
City
Rotterdam
Country
Netherlands
Facility Name
Teva Investigational Site 5361
City
Krakow
Country
Poland
Facility Name
Teva Investigational Site 5360
City
Warszawa
Country
Poland
Facility Name
Teva Investigational Site 5362
City
Wroclaw
Country
Poland
Facility Name
Teva Investigational Site 5363
City
Wroclaw
Country
Poland
Facility Name
Teva Investigational Site 9009
City
Claremont, Cape Town
Country
South Africa
Facility Name
Teva Investigational Site 9017
City
Overport, Durban
Country
South Africa
Facility Name
Teva Investigational Site 9013
City
Panorama, Cape Town
Country
South Africa
Facility Name
Teva Investigational Site 3158
City
Barcelona
Country
Spain
Facility Name
Teva Investigational Site 3164
City
Córdoba
Country
Spain
Facility Name
Teva Investigational Site 3160
City
Madrid
Country
Spain
Facility Name
Teva Investigational Site 3428
City
Bristol
Country
United Kingdom
Facility Name
Teva Investigational Site 3430
City
Coventry
Country
United Kingdom
Facility Name
Teva Investigational Site 3429
City
Liverpool
Country
United Kingdom
Facility Name
Teva Investigational Site 3432
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25281416
Citation
D'Haens G, Sandborn WJ, Colombel JF, Rutgeerts P, Brown K, Barkay H, Sakov A, Haviv A, Feagan BG; Laquinimod for Crohn's Disease Investigators. A phase II study of laquinimod in Crohn's disease. Gut. 2015 Aug;64(8):1227-35. doi: 10.1136/gutjnl-2014-307118. Epub 2014 Oct 3.
Results Reference
derived

Learn more about this trial

Laquinimod Phase IIa Study in Active Crohn's Disease

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