Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-02 @ 7:33 PM
Study NCT ID:
NCT00621959
Status:
COMPLETED
Last Update Posted:
2020-07-16
First Post:
2008-02-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
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This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Matched placebo tablets once daily', 'otherNumAtRisk': 295, 'otherNumAffected': 30, 'seriousNumAtRisk': 295, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'LCTZ', 'description': '5 mg levocetirizine dihydrochloride tablet once daily', 'otherNumAtRisk': 301, 'otherNumAffected': 29, 'seriousNumAtRisk': 301, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'seriousEvents': [{'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matched placebo tablets once daily'}, {'id': 'OG001', 'title': 'LCTZ', 'description': '5 mg levocetirizine dihydrochloride tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '8.96', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '8.77', 'spread': '3.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.546', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.31', 'pValueComment': 'If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.', 'estimateComment': "The difference presented is 'Levocetirizine 5 mg - Placebo'", 'groupDescription': "The Null Hypothesis for the primary endpoint is expressed as follows: 'The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA including treatment and center as factors and baseline mean score as covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Over the total treatment period (14 days)', 'description': 'Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). The total score varies from 0 to 15.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants from the Intent-To-Treat (ITT) population with available T5SS over the Total Treatment Period'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matched placebo tablets once daily'}, {'id': 'OG001', 'title': 'LCTZ', 'description': '5 mg levocetirizine dihydrochloride tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.07', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '1.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.442', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.12', 'pValueComment': 'If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.', 'estimateComment': "The difference presented is 'Levocetirizine 5 mg - Placebo'", 'groupDescription': "The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)', 'description': 'The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants from the Intent-To-Treat (ITT) population with available overall RQLQ score at Endpoint visit and at Baseline'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Matched placebo tablets once daily'}, {'id': 'FG001', 'title': 'LCTZ', 'description': '5 mg levocetirizine dihydrochloride tablet once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'In all 791 subjects have been screened and 596 have been randomized', 'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '301'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}, {'groupId': 'FG001', 'numSubjects': '292'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '596', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Matched placebo tablets once daily'}, {'id': 'BG001', 'title': 'LCTZ', 'description': '5 mg levocetirizine dihydrochloride tablet once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.36', 'spread': '11.05', 'groupId': 'BG000'}, {'value': '37.02', 'spread': '11.99', 'groupId': 'BG001'}, {'value': '37.18', 'spread': '11.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '405', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '596', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 596}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2008-02-11', 'resultsFirstSubmitDate': '2009-06-18', 'studyFirstSubmitQcDate': '2008-02-21', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-06-18', 'studyFirstPostDateStruct': {'date': '2008-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)', 'timeFrame': 'Over the total treatment period (14 days)', 'description': 'Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). The total score varies from 0 to 15.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score', 'timeFrame': 'Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)', 'description': 'The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['levocetirizine', 'Xyzal', 'Seasonal Allergic Rhinitis', 'total symptom score', 'quality of life'], 'conditions': ['Seasonal Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '20377116', 'type': 'DERIVED', 'citation': 'Segall N, Gawchik S, Georges G, Haeusler JM. Efficacy and safety of levocetirizine in improving symptoms and health-related quality of life in US adults with seasonal allergic rhinitis: a randomized, placebo-controlled study. Ann Allergy Asthma Immunol. 2010 Mar;104(3):259-67. doi: 10.1016/j.anai.2009.12.003.'}, {'pmid': '20350147', 'type': 'DERIVED', 'citation': 'Mansfield LE, Hampel F, Haeusler JM, Georges G. Study of levocetirizine in seasonal allergic rhinitis. Curr Med Res Opin. 2010 Jun;26(6):1269-75. doi: 10.1185/03007991003745233.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The study objective is to investigate the efficacy of levocetirizine in reducing symptoms associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with a history of SAR symptoms\n* A positive skin prick test at least one grass allergen\n* Moderate - severe SAR symptoms at baseline\n* Women of childbearing potential must use a medically acceptable form of contraception\n* 80% compliance on run in study medication and 80% compliance on completing the diary\n\nExclusion Criteria:\n\n* The presence of any clinically significant comorbid disease which may interfere with the study assessments\n* The presence of renal disease\n* Pregnant or breastfeeding\n* Subject is currently participating in another clinical trial\n* Known hypersensitivity to piperazines or any of the excipients\n* Intake of medications prohibited before the start of the trial\n* Subjects who started or changed the dose of immunotherapy\n* Rhinitis medicamentosa\n* Subjects with a recent history (within the last 2 years) of drug or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT00621959', 'briefTitle': 'A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine 5 mg Once Daily Given for 2 Weeks in Subjects 18 yr of Age and Older With Seasonal Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'A00430'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matched placebo tablets once daily', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LCTZ', 'description': '5 mg levocetirizine dihydrochloride tablet', 'interventionNames': ['Drug: levocetirizine dihydrochloride']}], 'interventions': [{'name': 'levocetirizine dihydrochloride', 'type': 'DRUG', 'otherNames': ['Xyzal'], 'description': '5mg daily (oral tablet) for 14 days', 'armGroupLabels': ['LCTZ']}, {'name': 'placebo', 'type': 'DRUG', 'description': '0mg (matching oral tablet)for 14 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'city': 'Albany', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 31.57851, 'lon': -84.15574}}, {'city': 'Lilburn', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.8901, 'lon': -84.14297}}, {'city': 'Savannah', 'state': 'Georgia', 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'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}