Crohn's DiseasePhase 2NCT00737932
Laquinimod Phase IIa Study in Active Crohn's Disease
A Phase 2 study testing Laquinimod in people with Crohn's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 34 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Laquinimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 34 sitesin 9 countries
- Study dates
- May 2010to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
34 sites in 9 countries.
34 sites in 9 countries
France6 sites
Teva Investigational Site 5351
Amiens
Teva Investigational Site 5352
Clichy
Teva Investigational Site 5353
La Tronche
Teva Investigational Site 5350
Lille
Teva Investigational Site 5354
Nice
Teva Investigational Site 5355
Paris
Israel6 sites
Teva Investigational Site 8048
Haifa
Teva Investigational Site 8046
Jerusalem, IL
Teva Investigational Site 8047
Petah Tikva, IL
Teva Investigational Site 8050
Ramat Gan, IL
Teva Investigational Site 8051
Rehovot, IL
Teva Investigational Site 8049
Tel Aviv, IL
Poland4 sites
Teva Investigational Site 5361
Krakow
Teva Investigational Site 5360
Warsaw
Teva Investigational Site 5362
Wroclaw
Teva Investigational Site 5363
Wroclaw
United Kingdom4 sites
Teva Investigational Site 3428
Bristol
Teva Investigational Site 3430
Coventry
Teva Investigational Site 3429
Liverpool
Teva Investigational Site 3432
London
Belgium3 sites
Teva Investigational Site 3711
Bonheiden
Teva Investigational Site 3712
Leuven
Teva Investigational Site 3713
Roeselare
Italy3 sites
Teva Investigational Site 3069
Roma
Teva Investigational Site 3070
Roma
Teva Investigational Site 3072
San Donato Milanese (MI)
South Africa3 sites
Teva Investigational Site 9009
Claremont, Cape Town
Teva Investigational Site 9017
Overport, Durban
Teva Investigational Site 9013
Panorama, Cape Town
Spain3 sites
Teva Investigational Site 3158
Barcelona
Teva Investigational Site 3164
Córdoba
Teva Investigational Site 3160
Madrid
Netherlands2 sites
Teva Investigational Site 3819
Amsterdam
Teva Investigational Site 3820
Rotterdam
About this study
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.
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.
- Conditions
- Crohn's Disease
- Being tested
- Laquinimod, placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaquinimodDrug
Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment
placeboOther
Matching placebo for 8 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| Laquinimod | Experimental | Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts) Receives: Drug: Laquinimod |
| Placebo | Placebo comparator | Matching placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startMay 2010
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geert D'Haens, MD PhD, Principal investigator, Imelda General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737932
- Sponsor's protocol ID
- CD-LAQ-201
- Status last verified
- Mar 2015
- First submitted
- 18 Aug 2008
- Last updated
- 20 Mar 2015
- Results posted
- No
Publications
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.
PubMed 25281416
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00737932
- Acronym / sponsor ID
- CD-LAQ-201
- Conditions
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laquinimod | Experimental | Drug: LaquinimodLaquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts) |
| Placebo | Placebo comparator | Other: placeboMatching placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaquinimodLaquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment | Drug | Laquinimod |
| placeboMatching placebo for 8 weeks of treatment | Other | Placebo |
Primary outcome
Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- Derived from this study: PubMed 25281416D'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert D'Haens, MD PhD principal investigator
Imelda General Hospital
34 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laquinimod in people with Crohn's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 34 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in France, Israel, Poland, United Kingdom, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00737932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.