Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT02069535
Status:
COMPLETED
Last Update Posted:
2015-01-06
First Post:
2014-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Trial to Assess the Tolerability of AVANZ® Cupressus Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-05', 'studyFirstSubmitDate': '2014-02-18', 'studyFirstSubmitQcDate': '2014-02-20', 'lastUpdatePostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of patients with IMP-related AEs', 'timeFrame': '6 treatment weeks'}], 'secondaryOutcomes': [{'measure': 'Frequency of patients with systemic reactions', 'timeFrame': '6 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cupressus arizonica'], 'conditions': ['Allergic Rhinoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'This trial is an open, national, multi-centre trial. The main objective of this trial is to assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica by measurement of related Adverse Events.', 'detailedDescription': 'The main objective of this trial is to assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica, the measurement rate is the frequency of patients with investigational medicinal product (IMP)-related adverse events (AEs) will be the primary endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A documented clinically relevant history of Cupressus arizonica pollen induced allergic rhinoconjunctivitis with or without asthma for at least one year prior to trial entry.\n* Positive Skin Prick Test (SPT) response to Cupressus arizonica pollen (wheal diameter ≥ 3 mm)\n\nExclusion Criteria:\n\n* History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.\n* Previous treatment with immunotherapy with Cupressus arizonica pollen extract within the last 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted).\n* Ongoing treatment with any allergen-specific immunotherapy product.\n* A history of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise-induced, food allergy, drugs or an idiopathic reaction).\n* A systemic disease affecting the immune system (e.g. insulin-dependent diabetes, autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not).'}, 'identificationModule': {'nctId': 'NCT02069535', 'briefTitle': 'An Open Trial to Assess the Tolerability of AVANZ® Cupressus Immunotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALK-Abelló A/S'}, 'officialTitle': 'An Open Trial to Assess the Tolerability of AVANZ® Cupressus Immunotherapy', 'orgStudyIdInfo': {'id': 'AV-X-03'}, 'secondaryIdInfos': [{'id': '2013-004720-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AVANZ Cupressus', 'description': 'AVANZ Cupressus', 'interventionNames': ['Biological: AVANZ Cupressus']}], 'interventions': [{'name': 'AVANZ Cupressus', 'type': 'BIOLOGICAL', 'description': 'AVANZ Cupressus', 'armGroupLabels': ['AVANZ Cupressus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Montserrat Fernández Rivas, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Clínico Universitario San Carlos, Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALK-Abelló A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}