Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-26 @ 6:38 PM
Study NCT ID:
NCT01018693
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2009-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Capacity of VAK694 When Combined With Allergen Immunotherapy to Bring About Specific Immune Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'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': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-17', 'studyFirstSubmitDate': '2009-11-24', 'studyFirstSubmitQcDate': '2009-11-24', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-dermal late phase response to allergen Measure: Wheal diameter', 'timeFrame': '10-12 months'}], 'secondaryOutcomes': [{'measure': 'To evaluate the immunomodulatory activity of VAK694 Measure: IgE/IgG, Th1/Th2 cytokine expression, Treg induction', 'timeFrame': '10-12 months'}, {'measure': 'To assess the effects of VAK694 combined with SCIT on the symptoms of seasonal allergic rhinitis Measure: mini-Respiratory Quality of Life Questionnaire (RQLQm) and visual analogue scale (VAS)', 'timeFrame': '10-12 months'}, {'measure': 'To preliminarily assess the ability of VAK694 to reduce the side-effects of subcutaneous immunotherapy Measure: Frequency and severity of local and systemic reactions to immunotherapy', 'timeFrame': '10-12 months'}]}, 'conditionsModule': {'keywords': ['Seasonal allergic rhinitis,', 'late phase response,', 'alutard avanz,', 'immunotherapy,', 'visual analogue scale,', 'mini rhinitis quality of life,', 'immune modulation'], 'conditions': ['Seasonal Allergic Rhinitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.hayfeverlondon.net', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether VAK694 when combined with subcutaneous immunotherapy leads to long term immune tolerance to allergen in individuals with seasonal allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of atopy, defined as a history of seasonal allergic rhinitis for at least 2 years (in relation to the grass pollen allergy season), and evidence of atopy, defined as a positive skin prick test (wheal difference allergen - negative control at least 3 mm) to grass pollen allergen at screening.\n* Male or female subjects aged between 18 and 60 years (inclusive)\n* Female subjects must be of non-childbearing potential\n* Subjects must weigh at least 50 kg with a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive)\n* Informed consent\n\nExclusion Criteria:\n\n* Treatment with intranasal corticosteroids within 28 days prior to the first dose.\n* History of asthma with treatment with inhaled or systemic corticosteroids within 6 months of the first dose.\n* History of COPD.\n* Any exposure to human monoclonal or polyclonal antibodies.\n* Any allergy immunotherapy within 3 years prior to screening.\n* Any prior grass pollen allergy immunotherapy.\n* FEV1 \\< 70% of predicted at screening or baseline.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01018693', 'briefTitle': 'A Study to Determine the Capacity of VAK694 When Combined With Allergen Immunotherapy to Bring About Specific Immune Tolerance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled Trial to Determine the Capacity of VAK694 to Elicit Long Term Immune Tolerance When Combined With Subcutaneous Allergen Immunotherapy for the Treatment of Seasonal Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'CVAK694A2205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VAK694 AND Immunotherapy (alutard)', 'interventionNames': ['Drug: VAK694; Alutard Avanz SQ']}, {'type': 'EXPERIMENTAL', 'label': ': VAK694 placebo AND Immunotherapy (alutard)', 'interventionNames': ['Drug: VAK694 placebo infusion; Alutard Avanz SQ']}, {'type': 'EXPERIMENTAL', 'label': 'VAK694 placebo AND Immunotherapy (alutard) placebo', 'interventionNames': ['Drug: VAK694 placebo infusion; Saline']}], 'interventions': [{'name': 'VAK694; Alutard Avanz SQ', 'type': 'DRUG', 'armGroupLabels': ['VAK694 AND Immunotherapy (alutard)']}, {'name': 'VAK694 placebo infusion; Alutard Avanz SQ', 'type': 'DRUG', 'armGroupLabels': [': VAK694 placebo AND Immunotherapy (alutard)']}, {'name': 'VAK694 placebo infusion; Saline', 'type': 'DRUG', 'armGroupLabels': ['VAK694 placebo AND Immunotherapy (alutard) placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}