Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-21 @ 7:03 AM
Study NCT ID:
NCT02443805
Status:
COMPLETED
Last Update Posted:
2019-10-14
First Post:
2015-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}, {'id': 'D000092542', 'term': 'Dust Mite Allergy'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'martine.legall@stallergenesgreer.com', 'phone': '+33 1 55 59 25 56', 'title': 'Martine Le Gall, Director of Clinical Development', 'organization': 'Stallergenes Greer'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.\n\n1,607 patients were randomized. 6 patients randomized by mistake did not receive any IP of the treatment period and were excluded from the Safety Set.\n\nAccordingly, the Safety Set comprised 1,601 patients.', 'eventGroups': [{'id': 'EG000', 'title': '300 IR', 'description': '300 IR tablet of HDM Allergen Extracts', 'otherNumAtRisk': 800, 'deathsNumAtRisk': 800, 'otherNumAffected': 424, 'seriousNumAtRisk': 800, 'deathsNumAffected': 0, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo tablet', 'otherNumAtRisk': 801, 'deathsNumAtRisk': 801, 'otherNumAffected': 223, 'seriousNumAtRisk': 801, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Oral pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 189}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Oedema mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Tongue oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Lip oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 117}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 136}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pharyngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 13}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 68}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Tick-borne viral encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pharyngeal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Chondromalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Plica syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Chronic fatigue syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': "Meniere's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 800, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 801, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Combined Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'OG000'}, {'value': '676', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '300 IR', 'description': '300 IR tablet of HDM Allergen Extracts'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '3.62', 'groupId': 'OG000', 'lowerLimit': '3.33', 'upperLimit': '3.92'}, {'value': '4.35', 'groupId': 'OG001', 'lowerLimit': '4.06', 'upperLimit': '4.66'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Source Model: Type III effects Covariates: Treatment group, Gender, Age Class, Sensitization Status, Asthma Status, Pooled Center, Baseline Average RTSS.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': "Average Total Combined Score (TCS), calculated for each patient as the average of the non-missing daily TCSs during the primary evaluation period. The daily TCS (scale 0-15) was the sum of the patient's daily Rhinitis Total Symptom Score (RTSS, scale 0-12) and daily Rescue Medication Score (RMS, scale 0-3). Lower is better.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized patients (pts) who received at least one dose of the IP of treatment period and had at least one primary efficacy evaluation during the overall treatment period: 1,476 pts. Among these pts, only those with efficacy evaluation during the primary evaluation period were included in the primary analysis: 1,262 pts.'}, {'type': 'SECONDARY', 'title': 'Average Rhinitis Total Symptom Score (RTSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'OG000'}, {'value': '676', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '300 IR', 'description': '300 IR tablet of HDM Allergen Extracts'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '3.16', 'groupId': 'OG000', 'lowerLimit': '2.89', 'upperLimit': '3.43'}, {'value': '3.79', 'groupId': 'OG001', 'lowerLimit': '3.53', 'upperLimit': '4.07'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Average RTSS during the primary evaluation period. The daily Total Symptom Scores (RTSS) was the sum of the 4 rhinitis symptom scores: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe).\n\nIt ranges from 0 to 12. Lower is better.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized patients (pts) who received at least one dose of the IP of treatment period and had at least one primary efficacy evaluation during the overall treatment period: 1,476 pts. Among these pts, only those with efficacy evaluation during the primary evaluation period were included in the secondary analysis: 1,262 pts.'}, {'type': 'SECONDARY', 'title': 'Average Rescue Medication Score (RMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'OG000'}, {'value': '676', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '300 IR', 'description': '300 IR tablet of HDM Allergen Extracts'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.25'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '0.35'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized patients (pts) who received at least one dose of the IP of treatment period and had at least one primary efficacy evaluation during the overall treatment period: 1,476 pts. Among these pts, only those with efficacy evaluation during the primary evaluation period were included in the secondary analysis: 1,262 pts.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '300 IR', 'description': '300 IR tablet of HDM Allergen Extracts'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '802'}, {'groupId': 'FG001', 'numSubjects': '805'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '589'}, {'groupId': 'FG001', 'numSubjects': '678'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '213'}, {'groupId': 'FG001', 'numSubjects': '127'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Any other reason not above-mentioned', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was conducted between 29 September 2015 (first patient, first visit) and 25 June 2018 (last patient, last visit).', 'preAssignmentDetails': '2,174 (50.9%) and 486 (11.4%) patients were excluded before and during the placebo run-in period, respectively. The main reason for screen failures at these two stages was a failure to meet randomization criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '711', 'groupId': 'BG000'}, {'value': '765', 'groupId': 'BG001'}, {'value': '1476', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '300 IR', 'description': '300 IR tablet of HDM Allergen Extracts'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo tablet'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'spread': '13.07', 'groupId': 'BG000'}, {'value': '29.6', 'spread': '12.58', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '12.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '360', 'groupId': 'BG000'}, {'value': '396', 'groupId': 'BG001'}, {'value': '756', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '351', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '720', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '660', 'groupId': 'BG000'}, {'value': '719', 'groupId': 'BG001'}, {'value': '1379', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '660', 'groupId': 'BG000'}, {'value': '701', 'groupId': 'BG001'}, {'value': '1361', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '452', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '453', 'groupId': 'BG000'}, {'value': '477', 'groupId': 'BG001'}, {'value': '930', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The Full Analysis Set (FAS) included all randomized patients who received at least one dose of the IP of treatment period and had at least one primary efficacy evaluation during the overall treatment period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-05', 'size': 2003695, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-29T10:03', 'hasProtocol': True}, {'date': '2018-10-29', 'size': 1800666, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-29T10:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1607}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-26', 'studyFirstSubmitDate': '2015-04-29', 'resultsFirstSubmitDate': '2019-08-29', 'studyFirstSubmitQcDate': '2015-05-13', 'lastUpdatePostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-03', 'studyFirstPostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Combined Score', 'timeFrame': '12 months', 'description': "Average Total Combined Score (TCS), calculated for each patient as the average of the non-missing daily TCSs during the primary evaluation period. The daily TCS (scale 0-15) was the sum of the patient's daily Rhinitis Total Symptom Score (RTSS, scale 0-12) and daily Rescue Medication Score (RMS, scale 0-3). Lower is better."}], 'secondaryOutcomes': [{'measure': 'Average Rhinitis Total Symptom Score (RTSS)', 'timeFrame': '12 months', 'description': 'Average RTSS during the primary evaluation period. The daily Total Symptom Scores (RTSS) was the sum of the 4 rhinitis symptom scores: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe).\n\nIt ranges from 0 to 12. Lower is better.'}, {'measure': 'Average Rescue Medication Score (RMS)', 'timeFrame': '12 months', 'description': 'Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rhinitis, Allergic, Perennial', 'House Dust Mite Allergy']}, 'referencesModule': {'references': [{'pmid': '39035788', 'type': 'DERIVED', 'citation': 'Worm M, Demoly P, Okamoto Y, Vidal C, Daghildjian K, Yan K, Casale TB, Bergmann KC. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J. 2024 Jun 25;17(7):100924. doi: 10.1016/j.waojou.2024.100924. eCollection 2024 Jul.'}, {'pmid': '38225952', 'type': 'DERIVED', 'citation': 'Pfaar O, De Blay F, Canonica GW, Casale TB, Gevaert P, Hellings PW, Kowal K, Passalacqua G, Tortajada-Girbes M, Vidal C, Worm M, Bahbah F, Demoly P. Clinical benefits with 300 IR HDM SLIT tablet in Europeans with house dust mite allergic rhinitis: Post hoc analysis of a large phase 3 trial. World Allergy Organ J. 2023 Dec 22;17(1):100849. doi: 10.1016/j.waojou.2023.100849. eCollection 2024 Jan.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to assess the efficacy and safety of 12 months of treatment with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with HDM-associated allergic rhinitis.', 'detailedDescription': 'This study was a randomized, double-blind, placebo-controlled, phase III study with 2 parallel arms in adults and adolescents with HDM-associated allergic rhinitis (AR) for at least one year.\n\nThe primary objective was to assess the efficacy of STG320 sublingual tablets at a daily dosage of 300 IR when administered for 12 months to adults and adolescents with HDM-associated AR. The primary efficacy variable was the average Total Combined Score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Patients with HDM-associated allergic rhinitis (AR) for at least 1 year\n* Patients sensitized to D. pteronyssinus (D. pte) and/or D. farinae (D. far) defined on skin prick test and HDM-specific serum IgE\n\nMain Exclusion Criteria:\n\n* A history of rhinitis, rhinoconjunctivitis or asthma to allergens other than HDM, likely to result in rhinitis symptoms during the evaluation periods\n* Partly controlled or uncontrolled asthma\n* Controlled asthma requiring controller treatment(s) consistent with GINA 2014 treatment Steps 3 to 5'}, 'identificationModule': {'nctId': 'NCT02443805', 'briefTitle': 'Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stallergenes Greer'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Efficacy and Safety of STG320 Sublingual Tablets of House Dust Mite (HDM) Allergen Extracts in Adults and Adolescents With HDM-associated Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'SL75.14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '300 IR', 'description': '300 IR tablet of HDM Allergen Extracts', 'interventionNames': ['Biological: 300 IR']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': '300 IR', 'type': 'BIOLOGICAL', 'description': '300 IR tablet of HDM Allergen Extracts', 'armGroupLabels': ['300 IR']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33610', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South of Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Arnaud de Villeneuve', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Pascal Demoly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Arnaud de Villeneuve, Montpellier, France'}, {'name': 'Tom Casale, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South of Florida, Tampa, USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stallergenes Greer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}