Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-03 @ 6:57 AM
Study NCT ID:
NCT01720251
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2012-10-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gilles.dellacorte@anergis.ch', 'phone': '+41 21 651 92 30', 'title': 'Dr Gilles DELLA CORTE Clinical Development Director', 'organization': 'ANERGIS SA'}, 'certainAgreement': {'otherDetails': 'The PI of the trial owns options in the sponsor company and is member of the Board of Anergis SA', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'All patients having received at least one injection of Placebo (Safety Set)', 'otherNumAtRisk': 79, 'otherNumAffected': 59, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Allert 50 µg', 'description': 'All patients having received at least one injection of Allert 50 µg (Safety Set)', 'otherNumAtRisk': 78, 'otherNumAffected': 70, 'seriousNumAtRisk': 78, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'AllerT 100 µg', 'description': 'All patients having received at least one injection of Allert 100 µg (Safety Set)', 'otherNumAtRisk': 82, 'otherNumAffected': 70, 'seriousNumAtRisk': 82, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 82, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Injection site pain'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 82, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Injection site react'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 82, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Nasopharyngitis'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 82, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Injection site eryth'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 82, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Rhinitis'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 82, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Dyspnea'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 82, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Cough'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 82, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Pruritus'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 82, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Conjunctivitis'}, {'term': 'Injection site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 82, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Injection site oedem'}], 'seriousEvents': [{'term': 'conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'conjunctivitis'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Hypersensitivity'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Oropharyngeal discom'}, {'term': 'Skull fracture', 'notes': 'considered as non drug-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Skull fracture'}, {'term': 'Tongue oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Tongue oedema'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Urticaria'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Combined Rhinoconjunctivitis Symptom and Medication Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'SC injections of placebo\n\nplacebo: SC injections of placebo on days 1, 7, 14, 28 and 56'}, {'id': 'OG001', 'title': 'AllerT Low Dose', 'description': 'SC injections of AllerT 25 or 50 micrograms\n\nAllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56'}, {'id': 'OG002', 'title': 'AllerT Full Dose', 'description': 'SC injections of AllerT 50-100 micrograms\n\nAllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56'}], 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'spread': '0.603', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.530', 'groupId': 'OG001'}, {'value': '0.72', 'spread': '0.573', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 6 weeks during the birch pollen season 2013', 'description': 'The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first.\n\nThe scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2', 'unitOfMeasure': 'score (maximum=3)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'timeFrame': 'up to 6 weeks during the birch pollen season 2013', 'description': 'mini-RQLQ questionnaires', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability', 'timeFrame': 'from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks', 'description': 'Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Immunological Markers: Specific IgE and IgG4', 'timeFrame': 'before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013', 'description': 'blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'SC injections of placebo\n\nplacebo: SC injections of placebo on days 1, 7, 14, 28 and 56'}, {'id': 'FG001', 'title': 'AllerT Low Dose', 'description': 'SC injections of AllerT 25 or 50 micrograms\n\nAllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56'}, {'id': 'FG002', 'title': 'AllerT Full Dose', 'description': 'SC injections of AllerT 50-100 micrograms\n\nAllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'SC injections of placebo\n\nplacebo: SC injections of placebo on days 1, 7, 14, 28 and 56'}, {'id': 'BG001', 'title': 'AllerT Low Dose', 'description': 'SC injections of AllerT 25 or 50 micrograms\n\nAllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56'}, {'id': 'BG002', 'title': 'AllerT Full Dose', 'description': 'SC injections of AllerT 50-100 micrograms\n\nAllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'spread': '9.08', 'groupId': 'BG000'}, {'value': '36.2', 'spread': '9.92', 'groupId': 'BG001'}, {'value': '36.4', 'spread': '9.36', 'groupId': 'BG002'}, {'value': '35.6', 'spread': '9.45', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'In AllerT low dose group, one patient has been randomized but not treated explaining the difference beween baseline participants number and participant flow'}}, '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': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-30', 'studyFirstSubmitDate': '2012-10-29', 'resultsFirstSubmitDate': '2015-03-20', 'studyFirstSubmitQcDate': '2012-10-31', 'lastUpdatePostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-30', 'studyFirstPostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immunological Markers: Specific IgE and IgG4', 'timeFrame': 'before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013', 'description': 'blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4'}], 'primaryOutcomes': [{'measure': 'Combined Rhinoconjunctivitis Symptom and Medication Score', 'timeFrame': 'up to 6 weeks during the birch pollen season 2013', 'description': 'The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first.\n\nThe scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'up to 6 weeks during the birch pollen season 2013', 'description': 'mini-RQLQ questionnaires'}, {'measure': 'Safety and Tolerability', 'timeFrame': 'from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks', 'description': 'Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allergic rhinitis', 'birch pollen', 'immunotherapy'], 'conditions': ['Allergic Rhinitis', 'Rhinoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* moderate to severe allergic rhinoconjunctivitis to birch pollen:\n\n 1. Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two preceding birch pollen seasons\n 2. Previous use of anti-allergy medications during the two preceding birch pollen seasons\n 3. Positive SPT to birch pollen extract\n 4. Positive specific IgE CAP test for Bet v 1\n\nExclusion Criteria:\n\n* uncontrolled asthma, FEV1 \\< 80% of predicted\n* previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years\n* clinical symptoms due to allergens other than birch pollen during the whole trial period\n* history of anaphylaxis\n* positive skin prick test to AllerT\n* any other treatment or conditions which may increase the risk of the study for the subject or affect the efficacy assessments during the birch pollen season'}, 'identificationModule': {'nctId': 'NCT01720251', 'briefTitle': 'Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anergis'}, 'officialTitle': 'Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen', 'orgStudyIdInfo': {'id': 'AN004T'}, 'secondaryIdInfos': [{'id': '2011-002259-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'SC injections of placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AllerT low dose', 'description': 'SC injections of AllerT 25 or 50 micrograms', 'interventionNames': ['Drug: AllerT low dose']}, {'type': 'EXPERIMENTAL', 'label': 'AllerT full dose', 'description': 'SC injections of AllerT 50-100 micrograms', 'interventionNames': ['Drug: AllerT full dose']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'SC injections of placebo on days 1, 7, 14, 28 and 56', 'armGroupLabels': ['placebo']}, {'name': 'AllerT low dose', 'type': 'DRUG', 'otherNames': ['AllerT 25-50 micrograms'], 'description': 'SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56', 'armGroupLabels': ['AllerT low dose']}, {'name': 'AllerT full dose', 'type': 'DRUG', 'otherNames': ['AllerT 50-100 micrograms'], 'description': 'SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56', 'armGroupLabels': ['AllerT full dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Allergiklinikken', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Lungemedicinsk Forskningsafdeling', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Klinisk Institute', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'CHU de Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hopitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '4601', 'city': 'Rēzekne', 'country': 'Latvia', 'facility': 'Viktorija Vevere private practice of Allergology', 'geoPoint': {'lat': 56.51028, 'lon': 27.34}}, {'zip': '1002', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Paul Stradins Clinical University Hospital - Pulmonology Allergology', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '1003', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Center of examination and treatment of allergic diseases', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '50009', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Kaunas Clinics University Hospital', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '08431', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Allergy Clinic JSC Perspektyvos', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '08661', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University Hospital', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '10200', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Antakalnio affiliation of the Vilnius City Allergy Center', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '90153', 'city': 'Lodz', 'country': 'Poland', 'facility': 'SPZOZ Uniwersytecki Szpital Kliniczny - Allergology', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '90553', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Alergologii Centrum', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20095', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Alergotest', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '33100', 'city': 'Tarnów', 'country': 'Poland', 'facility': 'Alergo-Med', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}, {'zip': '01157', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Centrum Alergologii IRMED', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-368', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Silesian Piasts University of Medicine in Wrocław', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '54203', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Aler-med', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '41800', 'city': 'Zabrze', 'country': 'Poland', 'facility': 'NZOZ Przychodnia Lekarska Hipokrates', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'zip': '22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'University hospital Skane', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '70185', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Orebro University Hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': '72189', 'city': 'Västerås', 'country': 'Sweden', 'facility': 'Lungavdelningen, Vastmanlands', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}, {'zip': '1005', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Francois Spertini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Vaudois'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anergis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}