Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-01 @ 3:40 PM
Study NCT ID:
NCT00048295
Status:
COMPLETED
Last Update Posted:
2022-08-15
First Post:
2002-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alicaforsen (ISIS 2302) in Patients With 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': 'C089753', 'term': 'alicaforsen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2002-10-29', 'studyFirstSubmitQcDate': '2002-10-29', 'lastUpdatePostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2002-10-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.centerwatch.com', 'label': 'Type "ISIS 2302" in search box'}, {'url': 'http://www.acurian.com', 'label': 'Type "ISIS 2302" in search box, then click on "Crohn\'s Disease Alicaforsen Investigation"'}]}, 'descriptionModule': {'briefSummary': 'ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant role in the increase of inflammation. People with Crohn\'s disease have been shown to over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA, the "instruction" molecule that is required for the production of ICAM-1 protein. This trial will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or immunosuppressive drugs, and prednisone (or equivalent) at \\</= 30 mg per day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Age \\>/= 12 years\n2. Weight \\>/= 36 kg\n3. CDAI score of 220 - 400\n4. Documentation of Crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years\n5. No TNF-α inhibitor treatment for three months prior to first study drug infusion\n\nExclusion Criteria\n\n1. Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation\n2. Extensive external fistulization (\\> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy\n3. Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C\n4. Malignancy within 3 years or poorly controlled medical illness\n5. Requires intravenous heparin therapy or with a history of a bleeding problem"}, 'identificationModule': {'nctId': 'NCT00048295', 'briefTitle': "Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Ionis Pharmaceuticals, Inc.'}, 'officialTitle': "ISIS 2302-CS21, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn's Disease", 'orgStudyIdInfo': {'id': 'ISIS 2302-CS21'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Alicaforsen', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kortrijk', 'country': 'Belgium', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'city': 'Roeselare', 'country': 'Belgium', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'city': 'Hradic Kralove 2', 'country': 'Czechia'}, {'city': 'Olomouc', 'country': 'Czechia', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Ústí nad Orlicí', 'country': 'Czechia', 'geoPoint': {'lat': 49.97387, 'lon': 16.39361}}, {'city': 'Minden', 'country': 'Germany', 'geoPoint': {'lat': 52.28953, 'lon': 8.91455}}, {'city': 'Münster', 'country': 'Germany', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Torino', 'country': 'Italy', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Szczecin', 'country': 'Poland', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ionis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}}}}