Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT03987620
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2019-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002181', 'term': 'Candidiasis, Vulvovaginal'}, {'id': 'D014627', 'term': 'Vaginitis'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014848', 'term': 'Vulvovaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014847', 'term': 'Vulvitis'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C569338', 'term': 'ibrexafungerp'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.angulo@scynexis.com', 'phone': '(201) 884-5471', 'title': 'Dr. David Angulo', 'organization': 'SCYNEXIS'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks after last dose', 'eventGroups': [{'id': 'EG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': '300 mg BID for one day\n\nIbrexafungerp: Ibrexafungerp 300mg BID for one day', 'otherNumAtRisk': 298, 'deathsNumAtRisk': 298, 'otherNumAffected': 63, 'seriousNumAtRisk': 298, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching Placebo', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 15, 'seriousNumAtRisk': 151, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Cure (Complete Resolution of Signs and Symptoms)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': '300 mg BID for one day\n\nIbrexafungerp: Ibrexafungerp 300mg BID for one day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching Placebo'}], 'classes': [{'categories': [{'title': 'Clinical cure', 'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Clinical failure', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 8-14', 'description': 'The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Mycological Eradication (Negative Culture for Growth of Yeast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': '300 mg BID for one day\n\nIbrexafungerp: Ibrexafungerp 300mg BID for one day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching Placebo'}], 'classes': [{'categories': [{'title': 'Mycological eradication', 'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': 'Mycological persistence', 'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 8-14', 'description': 'The percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Clinical Cure and Mycological Eradication (Responder Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': '300 mg BID for one day\n\nIbrexafungerp: Ibrexafungerp 300mg BID for one day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching Placebo'}], 'classes': [{'categories': [{'title': 'Overall success', 'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Overall failure', 'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 8-14', 'description': 'The percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Complete Clinical Response at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': '300 mg BID for one day\n\nIbrexafungerp: Ibrexafungerp 300mg BID for one day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching Placebo'}], 'classes': [{'categories': [{'title': 'Clinical cure at Follow up', 'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Clinical failure at Follow up', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 25', 'description': 'The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of Ibrexafungerp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': '300 mg BID for one day\n\nIbrexafungerp: Ibrexafungerp 300mg BID for one day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching Placebo'}], 'classes': [{'categories': [{'title': 'Any treatment-emergent adverse event', 'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Any serious treatment-emergent adverse event', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Any treatment-related treatment-emergent serious adverse event', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Any treatment-emergent adverse event leading to treatment discontinuation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Any adverse event leading to death', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 29 Days', 'description': 'Number of subjects with treatment related adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': '300 mg BID for one day\n\nIbrexafungerp: Ibrexafungerp 300mg BID for one day'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '303'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'Withdrawn Before Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawn Before TOC', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Completed the TOC Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'Withdrawn At or After the TOC Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy or Use of antifungal therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants were recruited based on physician referral at 22 medical center between 07Jun2019 and 07Feb2020.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': '300 mg BID for one day\n\nIbrexafungerp: Ibrexafungerp 300mg BID for one day'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching Placebo'}, {'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': '296', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '445', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'spread': '10.45', 'groupId': 'BG000'}, {'value': '34.5', 'spread': '10.94', 'groupId': 'BG001'}, {'value': '34.2', 'spread': '10.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '399', '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': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '51', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '369', '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': 'United States', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-20', 'size': 825797, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-04T14:57', 'hasProtocol': True}, {'date': '2020-03-24', 'size': 353567, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-04T14:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, placebo-controlled, double-blind study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 455}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'dispFirstSubmitDate': '2021-03-22', 'completionDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-11', 'studyFirstSubmitDate': '2019-06-12', 'dispFirstSubmitQcDate': '2021-08-11', 'resultsFirstSubmitDate': '2021-06-30', 'studyFirstSubmitQcDate': '2019-06-12', 'dispFirstPostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-11', 'studyFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Cure (Complete Resolution of Signs and Symptoms)', 'timeFrame': 'Day 8-14', 'description': 'The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit'}], 'secondaryOutcomes': [{'measure': 'Mycological Eradication (Negative Culture for Growth of Yeast)', 'timeFrame': 'Day 8-14', 'description': 'The percentage of subjects with mycological eradication (negative culture for growth of Candida species) at the TOC visit'}, {'measure': 'Clinical Cure and Mycological Eradication (Responder Outcome)', 'timeFrame': 'Day 8-14', 'description': 'The percentage of subjects with clinical cure and mycological eradication (responder outcome) at the TOC visit'}, {'measure': 'Complete Clinical Response at Follow-up', 'timeFrame': 'Day 25', 'description': 'The percentage of subjects with complete resolution of signs and symptoms at the Follow-up (FU) visit'}, {'measure': 'Safety and Tolerability of Ibrexafungerp', 'timeFrame': 'Up to 29 Days', 'description': 'Number of subjects with treatment related adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaginitis', 'Yeast infection'], 'conditions': ['Candida Vulvovaginitis']}, 'referencesModule': {'references': [{'pmid': '36255448', 'type': 'DERIVED', 'citation': 'Goje O, Sobel R, Nyirjesy P, Goldstein SR, Spitzer M, Faught B, Larson S, King T, Azie NE, Angulo D, Sobel JD. Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306. J Womens Health (Larchmt). 2023 Feb;32(2):178-186. doi: 10.1089/jwh.2022.0132. Epub 2022 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.', 'detailedDescription': 'Subjects who meet all of the inclusion and none of the exclusion criteria will be enrolled into the study and will be randomized in a 2:1 ratio to either oral ibrexafungerp or ibrexafungerp matching placebo, as follows:\n\n* Oral ibrexafungerp 300-mg dose BID (bis in die) for 1 day\n* Oral ibrexafungerp matching placebo BID for 1 day\n\nThis is a randomized, double-blind study.\n\nApproximately 366 eligible subjects will be enrolled and randomized in a 2:1 ratio to one of the two study treatment groups. Subjects will be followed for assessments of efficacy and safety for approximately one month after study drug administration. The design of this study is identical to VANISH 303 Study: NCT03734991'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is a postmenarchal female subject 12 years and older\n* Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% Potassium Hydroxide (KOH) in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)\n\nExclusion Criteria:\n\n* Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)\n* Need for systemic and/or topical (vaginal) anti fungal treatment, including prescription or over-the-counter products during the study and treatment for vulvovaginal candidiasis (VVC) 28 days prior to randomization.\n* Subject has uncontrolled diabetes mellitus.\n* Subject has a vaginal sample with pH \\>4.5.\n* Subject has a history of or an active cervical/vaginal cancer.'}, 'identificationModule': {'nctId': 'NCT03987620', 'acronym': 'Vanish 306', 'briefTitle': 'Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scynexis, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (AVVC).', 'orgStudyIdInfo': {'id': 'SCY-078-306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ibrexafungerp (SCY-078)', 'description': '300 mg BID for one day', 'interventionNames': ['Drug: Ibrexafungerp']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ibrexafungerp', 'type': 'DRUG', 'otherNames': ['SCY-078'], 'description': 'Ibrexafungerp 300mg BID for one day', 'armGroupLabels': ['Ibrexafungerp (SCY-078)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85209', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mesa OB-GYN', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Red Rocks OBGYN', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Planned Parenthood Southern New England', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'New Generation Medical Research', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Healthcare Clinical Data Inc', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Physician Care Clinical Research LLC', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'CCT LLC - 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