Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT02245360
Status:
COMPLETED
Last Update Posted:
2016-01-11
First Post:
2014-09-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551013', 'term': 'Grazax'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dmitri.kazei@abbott.com', 'phone': '+31 294477008', 'title': 'Dmitri Kazei MD, PhD', 'organization': 'Abbott'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Grass Tablet 75,000 SQ-T', 'description': 'Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)\n\nPhleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days', 'otherNumAtRisk': 53, 'otherNumAffected': 26, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: placebo tablet given once daily over 60 days', 'otherNumAtRisk': 54, 'otherNumAffected': 12, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tongue oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Grass Tablet 75,000 SQ-T', 'description': 'Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)\n\nPhleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: placebo tablet given once daily over 60 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.684', 'spread': '1.691', 'groupId': 'OG000'}, {'value': '0.050', 'spread': '0.588', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline versus end of treatment (approx. 60 days)', 'description': 'measurement of IgG4 in serum', 'unitOfMeasure': 'mgA/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.'}, {'type': 'SECONDARY', 'title': 'Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Grass Tablet 75,000 SQ-T', 'description': 'Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)\n\nPhleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: placebo tablet given once daily over 60 days'}], 'classes': [{'categories': [{'measurements': [{'value': '22.751', 'spread': '29.364', 'groupId': 'OG000'}, {'value': '-2.756', 'spread': '16.933', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline versus end of treatment (approx. 60 days)', 'description': 'measurement of IgE in serum', 'unitOfMeasure': 'UA/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Grass Tablet 75,000 SQ-T', 'description': 'Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)\n\nPhleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: placebo tablet given once daily over 60 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Grass Tablet 75,000 SQ-T', 'description': 'Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)\n\nPhleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: placebo tablet given once daily over 60 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '34.1', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '34.9', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-09', 'studyFirstSubmitDate': '2014-09-17', 'resultsFirstSubmitDate': '2015-11-03', 'studyFirstSubmitQcDate': '2014-09-17', 'lastUpdatePostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-03', 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum', 'timeFrame': 'baseline versus end of treatment (approx. 60 days)', 'description': 'measurement of IgG4 in serum'}], 'secondaryOutcomes': [{'measure': 'Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment', 'timeFrame': 'baseline versus end of treatment (approx. 60 days)', 'description': 'measurement of IgE in serum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GRAZAX'], 'conditions': ['Seasonal Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'To investigate the immunologic effects and safety of 60-day treatment of the Standardized Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis.\n* Use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis.\n* Positive skin prick test response (wheal diameter ≥3 mm) to Phleum pratense.\n* If asthma, daily use of Inhaled corticosteroid (ICS) should be ≤400 microgram budesonide or equivalent\n* Moderate or higher level of Phleum pratense specific IgE (Immunoglobulin E) (defined as ≥IgE Class 2; or ≥0.70 Kilo Units/liter (kU/L))\n\nExclusion Criteria:\n\n* Reduced lung function (defined as FEV1 \\< 70% (FEV1=Forced Expiratory Volume in 1 second) of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2\n* Clinical history of uncontrolled asthma within 3 months prior to the screening visit'}, 'identificationModule': {'nctId': 'NCT02245360', 'briefTitle': 'Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the SQ Grass SLIT-tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis', 'orgStudyIdInfo': {'id': 'GRAS3001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Grass tablet 75,000 SQ-T', 'description': 'Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)', 'interventionNames': ['Drug: Phleum pratense grass pollen allergen extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Phleum pratense grass pollen allergen extract', 'type': 'DRUG', 'otherNames': ['GRAZAX/GRASTEK'], 'description': 'Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days', 'armGroupLabels': ['Grass tablet 75,000 SQ-T']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo tablet given once daily over 60 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '105077', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research facility ID ORG-001086', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115446', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research facility ID ORG-001018', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115478', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research facility ID ORG-001005', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119333', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research facility ID ORG-001009', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research facility ID ORG-001016', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '123182', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research facility ID ORG-001006', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '123182', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research facility ID ORG-001085', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '142190', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research facility ID ORG-001014', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '193231', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research facility ID ORG-001007', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '195030', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research facility ID ORG-001019', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '198216', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research facility ID ORG-001008', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443099', 'city': 'Samara', 'country': 'Russia', 'facility': 'Research facility ID ORG-001015', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '410028', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Research facility ID ORG-001021', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '214019', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Research facility ID ORG-001017', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '450000', 'city': 'Ufa', 'country': 'Russia', 'facility': 'Research facility ID ORG-001020', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}], 'overallOfficials': [{'name': 'Dmitri Kazei, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}