Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-26 @ 11:48 PM
Study NCT ID:
NCT04853992
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2021-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'disclosure@leo-pharma.com', 'phone': '+45 4494 5888', 'title': 'Clinical disclosure', 'organization': 'LEO Pharma A/S'}, 'certainAgreement': {'otherDetails': 'The sponsor seeks publication of all clinical trials in peer-reviewed journals within 18 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 18 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).', 'eventGroups': [{'id': 'EG000', 'title': 'Active', 'description': 'In this cross over study all participants received active treatment.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 9, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'In this cross over study all participants received placebo', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 6, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Blood immunoglobulin E increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Electrocardiogram ST segment elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Low density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'In this cross over study all participants received active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In this cross over study all participants received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.277', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '0.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'groupDescription': 'The primary endpoint, change from baseline in post-provocation Urticaria Activity Score (UASprovo) to the end of the treatment period, was compared between treatments with the null hypothesis that they are equal against the alternative that they are different. The primary efficacy endpoint was analysed using a linear mixed model, containing treatment, period and carryover effects, the factor site and additionally the value of UASprovo at baseline as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 7', 'description': "The Urticaria Activity Score (UAS) rates a participants' number of wheals and their itch severity on a scale from 0 to 6, with 6 being the most severe. UAS is assessed after provocation of urticaria by moderate exercise to cause sweating.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'In this cross over study all participants received active treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In this cross over study all participants received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of each treatment period (day 1 for the 1st treatment period or day 15 or 22 for the 2nd treatment period) until 3 days after end of each treatment period (day 11 for the 1st treatment period or day 25 or 32 for the 2nd treatment period)', 'unitOfMeasure': 'Number of AEs', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active - Placebo', 'description': 'Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days\n\nLEO 152020: LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.\n\nLEO 152020 placebo: LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.'}, {'id': 'FG001', 'title': 'Placebo - Active', 'description': 'Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days\n\nLEO 152020: LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.\n\nLEO 152020 placebo: LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.'}], 'periods': [{'title': 'Treatment Period A', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Wash Out', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Met exclusion criteria for next treatment phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period B', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active - Placebo', 'description': 'Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days\n\nLEO 152020: LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.\n\nLEO 152020 placebo: LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.'}, {'id': 'BG001', 'title': 'Placebo - Active', 'description': 'Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days\n\nLEO 152020: LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.\n\nLEO 152020 placebo: LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '56'}, {'value': '25', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '47'}, {'value': '25', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-08', 'size': 1816506, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-04T04:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Placebo-controlled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each treatment period will last 7 days with a wash-out period of 7 days between treatments'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2021-04-20', 'resultsFirstSubmitDate': '2023-07-11', 'studyFirstSubmitQcDate': '2021-04-20', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-20', 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)', 'timeFrame': 'Baseline to Day 7', 'description': "The Urticaria Activity Score (UAS) rates a participants' number of wheals and their itch severity on a scale from 0 to 6, with 6 being the most severe. UAS is assessed after provocation of urticaria by moderate exercise to cause sweating."}], 'secondaryOutcomes': [{'measure': 'Number of Treatment Emergent Adverse Events', 'timeFrame': 'From start of each treatment period (day 1 for the 1st treatment period or day 15 or 22 for the 2nd treatment period) until 3 days after end of each treatment period (day 11 for the 1st treatment period or day 25 or 32 for the 2nd treatment period)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholinergic Urticaria']}, 'referencesModule': {'references': [{'pmid': '38308655', 'type': 'DERIVED', 'citation': 'Grekowitz E, Metz M, Altrichter S, Bauer A, Brockow K, Heine G, Lionnet L, Saday KK, Hultsch T, Soerensen OE, Maurer M. Targeting histamine receptor 4 in cholinergic urticaria with izuforant (LEO 152020): results from a phase IIa randomized double-blind placebo-controlled multicentre crossover trial. Br J Dermatol. 2024 May 17;190(6):825-835. doi: 10.1093/bjd/ljae038.'}]}, 'descriptionModule': {'briefSummary': 'Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria', 'detailedDescription': 'This is a phase 2a, randomised, double-blind, placebo-controlled, cross-over trial conducted in Germany at 3-6 sites. Subjects will be randomised to one of two treatment sequences (A and B). Each treatment period will last 7 days with a wash-out period of 7 days between treatments. Half of the subjects will start with treatment A followed by treatment B while the other half will start with treatment B followed by treatment A. A safety follow-up visit will be performed 3 days after last dose of the tested medication.\n\nThe main assessment is an urticaria activity score. After a Pulse-controlled ergometry (PCE) provocation test subjects will be rated on their number of wheals and their itch severity, resulting in a sum score ranging from 0 to 6 points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Subject with a history of Cholinergic urticaria diagnosis for ≥ 6 months\n* Subject has active and uncontrolled Cholinergic urticaria disease at the time of screening and randomisation, as defined by the following:\n\n 1. Urticaria control test \\< 12 at screening\n 2. Urticaria Activity Score post-provocation ≥ 3\n* Recent history (within 6 months of screening) with documented inadequate response to standard dose as to marketing authorization of H1 antihistamines.\n\nMain Exclusion Criteria:\n\n* Other clearly dominating forms\\* of urticaria as aetiology for wheal and flare type reactions\n\n \\*These diseases are allowed as comorbidities, if cholinergic urticaria is the dominating form of chronic urticaria,\n* Systemic immunosuppressive medications within 4 weeks prior to screening,\n* Systemic drugs (e.g. oral drug) with antihistamine properties including H1 antihistamines and some antidepressants (e.g. tricyclic antidepressants) and H2 antihistamines 1 week prior to randomisation and throughout the trial. However, topical antihistamines in the form of nasal spray and eyedrops are allowed in the standard prescribed dose.'}, 'identificationModule': {'nctId': 'NCT04853992', 'briefTitle': 'Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria', 'organization': {'class': 'INDUSTRY', 'fullName': 'JW Pharmaceutical'}, 'officialTitle': 'Phase 2a Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria', 'orgStudyIdInfo': {'id': 'EXP-2177'}, 'secondaryIdInfos': [{'id': '2020-004961-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active - Placebo', 'description': 'Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days', 'interventionNames': ['Drug: LEO 152020', 'Drug: LEO 152020 placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo - Active', 'description': 'Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days', 'interventionNames': ['Drug: LEO 152020', 'Drug: LEO 152020 placebo']}], 'interventions': [{'name': 'LEO 152020', 'type': 'DRUG', 'description': 'LEO 152020 is a small drug molecule which can block the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.', 'armGroupLabels': ['Active - Placebo', 'Placebo - Active']}, {'name': 'LEO 152020 placebo', 'type': 'DRUG', 'description': 'LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.', 'armGroupLabels': ['Active - Placebo', 'Placebo - Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'LEO Investigational Site', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'LEO Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'LEO Investigational Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '79104', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'LEO Investigational Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'LEO Investigational Site', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '80802', 'city': 'München', 'country': 'Germany', 'facility': 'LEO Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'overallOfficials': [{'name': 'Medical Expert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LEO Pharma'}]}, 'ipdSharingStatementModule': {'url': 'https://www.leopharmatrials.com/en/for-professionals', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'accessCriteria': 'De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JW Pharmaceutical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'LEO Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}