Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT06790368
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2024-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092422', 'term': 'Venom Hypersensitivity'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood serum to perform immunological study of total IgE, serum tryptase, and specific IgE, IgG4, IgG1.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2024-09-16', 'studyFirstSubmitQcDate': '2025-01-17', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-Emergent adverse reactions (safety and tolerability) in participants diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.).', 'timeFrame': '12 months', 'description': 'Evaluation of the severity of reactions in relation to subcutaneous immunotherapy following the indications proposed by the World Allergy Organization (WAO).'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the effectiveness of treatment with immunotherapy, once the maintenance dose of 100 μg/mL is reached, in participants suffering spontaneous natural stings during the 1-year follow-up.', 'timeFrame': '12 months', 'description': 'Registration of allergic reactions, spontaneous natural stings and a controlled sting test in participants sensitised to hymenoptera venom (Apis mellifera and/or Vespula spp.).'}, {'measure': 'Immunological parameters of the participants after 12 months of treatment.', 'timeFrame': '12 months', 'description': 'Immunological study: total IgE, specific IgE, IgG4, IgG1 (total extract and molecular components of Vespula spp. and Apis mellifera). The immunological analysis will be performed according to the usual clinical practice of the site and the serum samples will be stored for the complete analysis in the facilities of the sponsor, using the ALEX technique.'}, {'measure': 'SEAIC (Spanish Society of Allergology and Clinical Immunology) Quality of life Questionnaire for people allergic to hymenoptera venom.', 'timeFrame': '12 months', 'description': 'The quality of life questionnaire consists of 14 questions, the first nine questions are mandatory. The score for each question is inverse to the order of the answer, i.e. the first answer scores 7 and the seventh 1. The score shall be obtained by adding up all the questions answered and dividing by the total number of questions answered. .The total score goes from 1 to 7, with 1 indicating the worst quality of life and 7 the best.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allergy', 'Immunotherapy', 'Apis mellifera', 'Vespula sp', 'controlled sting'], 'conditions': ['Allergy, Insect Venom', 'Allergy Insect Stinging', 'Insect Sting Allergy']}, 'referencesModule': {'references': [{'pmid': '21848758', 'type': 'BACKGROUND', 'citation': 'Krishna MT, Ewan PW, Diwakar L, Durham SR, Frew AJ, Leech SC, Nasser SM; British Society for Allergy and Clinical Immunology. Diagnosis and management of hymenoptera venom allergy: British Society for Allergy and Clinical Immunology (BSACI) guidelines. Clin Exp Allergy. 2011 Sep;41(9):1201-20. doi: 10.1111/j.1365-2222.2011.03788.x.'}, {'pmid': '35735250', 'type': 'BACKGROUND', 'citation': 'Ruiz-Leon B, Martinez San Ireneo M, de la Roca F, Arenas L, Alfaya Arias T, Cordobes C, Marques L, Vega A, Moreno-Aguilar C. The Lights and the Shadows of Controlled Sting Challenge With Hymenoptera. J Investig Allergol Clin Immunol. 2022 Oct 11;32(5):357-366. doi: 10.18176/jiaci.0838. Epub 2022 Jun 22.'}, {'pmid': '26817139', 'type': 'BACKGROUND', 'citation': 'Alfaya T, Vega A, Dominguez-Noche C, Ruiz B, Marques L, Sanchez-Morillas L. Longitudinal Validation of the Spanish Version of the Health-Related Quality of Life Questionnaire for Hymenoptera Venom Allergy (HRQLHA). J Investig Allergol Clin Immunol. 2015;25(6):426-30.'}], 'seeAlsoLinks': [{'url': 'http://www.seaic.org/.', 'label': 'Comite de Alergia a Himenopteros. "Cuestionario de Calidad de Vida en Alérgicos a Himenópteros".'}]}, 'descriptionModule': {'briefSummary': 'Observational clinical follow-up to evaluate the safety of immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions. It includes the evaluation of controlled and spontaneous stings. This study will be conducted in Spain (multicentric), multicentric and data will be collected prospectively.', 'detailedDescription': 'Observational, multicentric (Spain), prospective study and data will be collected properly. The total number of participants is expected to be 80. The patients aged equal or more than 14 years old, sentitized to himenoptera venom, not gender differentiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants of both gender aged 14 years or more diagnosed of allergy to Apis mellifera and/or Vespula spp. venom, susceptible to receive ITVH according to standard clinical practice.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* The study population consisted of allergic participants indicated for treatment with hymenoptera venom immunotherapy (Apis mellifera or Vespula spp.) according to standard clinical practice.\n* Participants of both sexes aged 14 years or more.\n* Participants who have not received immunotherapy with hymenoptera venom in the previous 5 years.\n* Participants who have agreed to take part in the study and sign the informed consent form. In the case of minors, the patient's parent or guardian must also sign.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study.\n* Participants who do not agree to participate and/or do not sign the informed consent form.\n* Participants who do not comply with medical indications or do not cooperate with immunotherapy treatment."}, 'identificationModule': {'nctId': 'NCT06790368', 'acronym': 'Venox-23', 'briefTitle': 'Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inmunotek S.L.'}, 'officialTitle': 'Prospective Clinical Follow-up to Evaluate the Safety of Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.', 'orgStudyIdInfo': {'id': 'ITK-VENOX-2023-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients allergic to hymenoptera venom', 'description': 'Patients allergic to hymenoptera venom and receive the clinical recommendation to be treated with VENOX inmunotherapy (ATC code: V01AA07)', 'interventionNames': ['Biological: VENOX']}], 'interventions': [{'name': 'VENOX', 'type': 'BIOLOGICAL', 'description': 'Treatment with allergy vaccine against Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.', 'armGroupLabels': ['Patients allergic to hymenoptera venom']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Teresa Alfaya', 'role': 'CONTACT', 'email': 'teresa.alfaya@salud.madrid.org', 'phone': '+34 916219400'}, {'name': 'Jesús Macías Iglesias', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitario Fundación Alcorcón', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'city': 'Córdoba', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'M.ª Berta Ruiz León, Dr', 'role': 'CONTACT', 'email': 'rulebe@gmail.com'}], 'facility': 'Hospital Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '19002', 'city': 'Guadalajara', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Arantza Vega Castro', 'role': 'CONTACT', 'email': 'arantza.vega@gmail.com', 'phone': '+34 949209200'}, {'name': 'Juan María Beitia Mazuecos', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitario de Guadalajara', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}], 'centralContacts': [{'name': 'Miguel Casanovas', 'role': 'CONTACT', 'email': 'mcasanovas@inmunotek.com', 'phone': '+34 91208942'}, {'name': 'Raquel Caballero', 'role': 'CONTACT', 'email': 'rcaballero@inmunotek.com', 'phone': '+34 607600638'}], 'overallOfficials': [{'name': 'Arantza Vega Castro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Guadalajara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inmunotek S.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}