Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT00737932
Status:
COMPLETED
Last Update Posted:
2015-03-20
First Post:
2008-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laquinimod Phase IIa Study in Active Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C476223', 'term': 'laquinimod'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-19', 'studyFirstSubmitDate': '2008-08-18', 'studyFirstSubmitQcDate': '2008-08-19', 'lastUpdatePostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment.', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '25281416', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects diagnosed with Crohn's disease for at least 3 months prior to screening.\n2. Moderate to severe Crohn's disease patients as determined by the CDAI score\n\nExclusion Criteria:\n\n1. Subjects who have had recent bowel surgery\n2. Subjects with clinically significant GI obstructive symptoms\n3. Subjects with a clinically significant or unstable medical or surgical condition\n4. Subjects with unstable doses of standard of care medications (5-ASA, antibiotics, oral corticosteroids, immunosuppressants )\n5. Women who are pregnant or nursing or who intend to be during the study period.\n6. Women of child-bearing potential who do not practice an acceptable method of birth control"}, 'identificationModule': {'nctId': 'NCT00737932', 'briefTitle': "Laquinimod Phase IIa Study in Active Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': "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.", 'orgStudyIdInfo': {'id': 'CD-LAQ-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laquinimod', 'description': 'Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts)', 'interventionNames': ['Drug: Laquinimod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Laquinimod', 'type': 'DRUG', 'description': 'Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment', 'armGroupLabels': ['Laquinimod']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Matching placebo for 8 weeks of treatment', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Teva Investigational Site 3711', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'Teva Investigational Site 3712', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Roeselare', 'country': 'Belgium', 'facility': 'Teva Investigational Site 3713', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'city': 'Amiens', 'country': 'France', 'facility': 'Teva Investigational Site 5351', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Clichy', 'country': 'France', 'facility': 'Teva Investigational Site 5352', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'La Tronche', 'country': 'France', 'facility': 'Teva Investigational Site 5353', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'city': 'Lille', 'country': 'France', 'facility': 'Teva Investigational Site 5350', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Nice', 'country': 'France', 'facility': 'Teva Investigational Site 5354', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'country': 'France', 'facility': 'Teva Investigational Site 5355', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Jerusalem', 'state': 'IL', 'country': 'Israel', 'facility': 'Teva Investigational Site 8046', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Petah Tikva', 'state': 'IL', 'country': 'Israel', 'facility': 'Teva Investigational Site 8047', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Ramat Gan', 'state': 'IL', 'country': 'Israel', 'facility': 'Teva Investigational Site 8050', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Rehovot', 'state': 'IL', 'country': 'Israel', 'facility': 'Teva Investigational Site 8051', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'city': 'Tel Aviv', 'state': 'IL', 'country': 'Israel', 'facility': 'Teva Investigational Site 8049', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Teva Investigational Site 8048', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Teva Investigational Site 3069', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Teva Investigational Site 3070', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'San Donato Milanese (MI)', 'country': 'Italy', 'facility': 'Teva Investigational Site 3072', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Teva Investigational Site 3819', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Teva Investigational Site 3820', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Teva Investigational Site 5361', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Teva Investigational Site 5360', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Teva Investigational Site 5362', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Teva Investigational Site 5363', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Claremont, Cape Town', 'country': 'South Africa', 'facility': 'Teva Investigational Site 9009'}, {'city': 'Overport, Durban', 'country': 'South Africa', 'facility': 'Teva Investigational Site 9017'}, {'city': 'Panorama, Cape Town', 'country': 'South Africa', 'facility': 'Teva Investigational Site 9013'}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Teva Investigational Site 3158', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Córdoba', 'country': 'Spain', 'facility': 'Teva Investigational Site 3164', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Teva Investigational Site 3160', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Teva Investigational Site 3428', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Teva Investigational Site 3430', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Teva Investigational Site 3429', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Teva Investigational Site 3432', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': "Geert D'Haens, MD PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imelda General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}