Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-27 @ 7:03 PM
Study NCT ID:
NCT00929968
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2009-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'dispFirstSubmitDate': '2012-05-02', 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2009-06-29', 'dispFirstSubmitQcDate': '2012-05-02', 'studyFirstSubmitQcDate': '2009-06-29', 'dispFirstPostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of prolonged administration of multiple intravenous doses of VAK694 as well as the preliminary efficacy of multiple intravenous doses of VAK694 in atopic subjects', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects', 'timeFrame': '12 weeks'}, {'measure': 'Change in serum levels of total and antigen specific IgE and total and antigen specific IgG', 'timeFrame': '12 weeks'}, {'measure': 'Immunogenicity of multiple intravenous doses of VAK694', 'timeFrame': '12 weeks'}, {'measure': 'Changes in rhinitis visual-analogue score and the use of symptom relief during both the peak and entire allergy season.', 'timeFrame': '12 weeks'}, {'measure': 'Changes in biomarkers of immunomodulation', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'keywords': ['Allergic rhinitis,', 'atopic patients,', 'seasonal allergy,', 'ragweed allergy'], 'conditions': ['Allergic Rhinitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6443', 'label': 'Results for CVAK694A2201 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and tolerability of multiple doses of VAK694 as well as change in symptoms and biomarkers in patients with seasonal allergic rhinitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects between ages of 18 to 60 in good health\n* History of atopy for at least 2 years and positive skin prick test to ragweed allergen\n\nExclusion criteria:\n\n* History of asthma treated with corticosteroids\n* Smokers with a smoking history of \\> 10 pack/years or smoking in the past year\n* History of chronic obstructive pulmonary disease\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00929968', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo and Calibrator Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Intravenous Doses of VAK694 in Subjects With Seasonal Rhinitis During Natural Exposure to Allergen', 'orgStudyIdInfo': {'id': 'CVAK694A2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo to VAK694', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'VAK694', 'interventionNames': ['Biological: VAK694']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluticasone propionate', 'interventionNames': ['Drug: Fluticasone']}], 'interventions': [{'name': 'Placebo', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Placebo to VAK694']}, {'name': 'VAK694', 'type': 'BIOLOGICAL', 'armGroupLabels': ['VAK694']}, {'name': 'Fluticasone', 'type': 'DRUG', 'armGroupLabels': ['Fluticasone propionate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}