Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT00575003
Status:
COMPLETED
Last Update Posted:
2009-04-27
First Post:
2007-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C559986', 'term': 'CYT003-QbG10'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-24', 'studyFirstSubmitDate': '2007-12-14', 'studyFirstSubmitQcDate': '2007-12-14', 'lastUpdatePostDateStruct': {'date': '2009-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life', 'timeFrame': 'on 4 occations over 1 year'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of the vaccine by collection of adverse events', 'timeFrame': 'at each visit'}]}, 'conditionsModule': {'conditions': ['Perennial Allergy to House Dust Mite and/or Cat']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens\n\nExclusion Criteria:\n\n* Clinical relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments.\n* Use of any concomitant medication that could affect the patient's study treatment response or assessment results.\n* Any clinically relevant concomitant disease as judged by the investigator.\n* Pregnancy or female planning to become pregnant during the study."}, 'identificationModule': {'nctId': 'NCT00575003', 'briefTitle': 'Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytos Biotechnology AG'}, 'officialTitle': 'Double-Blind, Placebo-Controlled Study to Investigate an Immunomodulatory Therapy (CYT003-QbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis', 'orgStudyIdInfo': {'id': 'CYT003-QbG10 08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: CYT003-QbG10']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: CYT003-QbG10']}], 'interventions': [{'name': 'CYT003-QbG10', 'type': 'DRUG', 'description': '6 subcutaneous injections', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50406', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Clinic, Out-Patients Department', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '51014', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Clinic, Lungs Clinic', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '1003', 'city': 'Riga', 'country': 'Latvia', 'facility': 'The centre of the investigation in treatment of allergic disease', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '1010', 'city': 'Riga', 'country': 'Latvia', 'facility': 'SNC Uniclinica', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '45130', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Kaunas County Hospital, Department of Pulmonology and Allergology', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '50009', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Kaunas Medical University Hospital, Department of Pulmonology and Immunology', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '08661', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University Hospital, Centre of Pulmonology and Allergology', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'overallOfficials': [{'name': 'Audra Blaziene', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vilnius University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytos Biotechnology AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Philipp Mueller', 'oldOrganization': 'Cytos Biotechnology AG'}}}}