Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-25 @ 4:47 PM
Study NCT ID:
NCT02943720
Status:
COMPLETED
Last Update Posted:
2018-01-10
First Post:
2016-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], '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'}]}}, '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': 'ACTUAL', 'count': 421}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-09', 'studyFirstSubmitDate': '2016-10-21', 'studyFirstSubmitQcDate': '2016-10-22', 'lastUpdatePostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined Symptom and Medication Score (CSMS)', 'timeFrame': '2 to 6 months after the end of treatment', 'description': 'the CSMS will be assessed daily throughout the first birch pollen season following the end of the preseasonal 2-month treatment. The difference in average daily CSMS per treatment group will be compared taking into account all days of the birch pollen season at each study center. All patients will receive treatment during the preceding winter or spring and will thus have the primary outcome assessment performed between 2 and 6 months after the end of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects 18 to 65 yrs old, male or female\n* moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons\n* positive Skin Prick Test (SPT) to birch pollen extract\n* positive specific IgE CAP to Bet v1.\n\nExclusion Criteria:\n\n* persistent non-controlled asthma (Forced Expiratory Volume, FEV1 \\< 85% of predicted),\n* previous specific immunotherapy (SIT) to tree pollens,\n* previous SIT to any allergen within 5 years,\n* previous history of severe anaphylactic reaction,\n* perennial allergic Rhinitis/Rhinoconjunctivitis,\n* other disorder possibly influencing the trial outcomes,\n* pregnancy,\n* any severely debilitating disease,\n* primary or secondary immunodeficiency or treatment with immunosuppressor drugs within one month prior to randomization (oral steroids, other immunosuppressors).'}, 'identificationModule': {'nctId': 'NCT02943720', 'acronym': 'ATIBAR', 'briefTitle': 'ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anergis'}, 'officialTitle': 'A Multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT in Adults With Birch Pollen Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'AN006T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '5 SC injections in 2 months', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AllerT 50 ug', 'description': '5 SC injections in 2 months', 'interventionNames': ['Drug: AllerT']}, {'type': 'EXPERIMENTAL', 'label': 'AllerT 10 ug', 'description': '5 SC injections in 2 months', 'interventionNames': ['Drug: AllerT']}], 'interventions': [{'name': 'AllerT', 'type': 'DRUG', 'description': 'Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution', 'armGroupLabels': ['AllerT 10 ug', 'AllerT 50 ug']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Lungemedicinsk Forskningsafdeling,', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Herlev-Gentofte Hospital, Hud - og Allergiafdelingen,', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'zip': '6000', 'city': 'Kolding', 'country': 'Denmark', 'facility': 'Kolding Hospital', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}, {'zip': '4700', 'city': 'Næstved', 'country': 'Denmark', 'facility': 'Næstved Sygehus, Lungemedicinsk avd', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense Universitetshospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '90220', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulun Yliopistollinen sairaala Korva-, nenä- ja kurkkutautien poliklinikka.', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'TYKS T-sairaala Allergiayksikkö TA2', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '13057', 'city': 'Berlin', 'country': 'Germany', 'facility': 'HNO Heilkunde u. Allergologie praxis', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '01139', 'city': 'Dresden', 'country': 'Germany', 'facility': 'HNO Praxis Dr Yarin', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '47051', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'HNO Praxis Dr Thieme', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'HNO Praxis Dr Horn', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Dres Heimlich HNO praxis', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '04109', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Medamed', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '65183', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Zentrum fur Rhinologie une Allergologie', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': '50009', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Hospital of Lithuanian University', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '50154', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'CD8 Klinika', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '08661', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University Hospital', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '10200', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius City Clinical hospital', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '2743', 'city': 'Harestua', 'country': 'Norway', 'facility': 'Harestua Medisinske Senter', 'geoPoint': {'lat': 60.1944, 'lon': 10.71896}}, {'zip': '0855', 'city': 'Oslo', 'country': 'Norway', 'facility': 'KAL Kliniken', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '1400', 'city': 'Ski', 'country': 'Norway', 'facility': 'Ski Ore-Nese-Hals', 'geoPoint': {'lat': 59.71949, 'lon': 10.83576}}, {'zip': '80405', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Clinica Vitae', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '31024', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Grazyna Pulka Specjalistyczny Osradek All-Med', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31624', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Malopolskie Centrum Alergologii', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '35205', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'EMED Centrum Uslug Medycznych', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '96100', 'city': 'Skierniewice', 'country': 'Poland', 'facility': 'Clinmedica Research OMC', 'geoPoint': {'lat': 51.95485, 'lon': 20.15837}}, {'zip': '53201', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'All-Med Specjalistyczna Opieka Medyczna', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '54203', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'NZOZ-ALER-med Specjalistyczna Opieka Medycna', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '08501', 'city': 'Bardejov', 'country': 'Slovakia', 'facility': 'ALIAN s.r.o. Ambulancia alergologie', 'geoPoint': {'lat': 49.29175, 'lon': 21.27271}}, {'zip': '94501', 'city': 'Komárno', 'country': 'Slovakia', 'facility': 'Imunologia a alergologia', 'geoPoint': {'lat': 48.11667, 'lon': 18.31667}}, {'zip': '04022', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'ALERSA s.r.o. Imunoalergologicka ambulancia', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '04022', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'STALERG s.r.o. Imunoalergologicka ambulancia', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '93401', 'city': 'Levice', 'country': 'Slovakia', 'facility': 'DANIMED s.r.o. Ambulancia klinickejimunologie a alergologie', 'geoPoint': {'lat': 48.21563, 'lon': 18.60705}}, {'zip': '08001', 'city': 'Prešov', 'country': 'Slovakia', 'facility': 'EMED s.r.o. Alergoimunologické centrum', 'geoPoint': {'lat': 48.99923, 'lon': 21.2355}}, {'zip': '94201', 'city': 'Šurany', 'country': 'Slovakia', 'facility': 'Imunoalergologicka ambulancia', 'geoPoint': {'lat': 48.08613, 'lon': 18.18447}}, {'zip': '11324', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Trial Alliance', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Stephen Durham, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'NHLI, Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anergis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}