Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-26 @ 2:21 PM
Study NCT ID:
NCT03780166
Status:
WITHDRAWN
Last Update Posted:
2019-09-13
First Post:
2018-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010392', 'term': 'Pemphigus'}], 'ancestors': [{'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656179', 'term': 'parsaclisib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study was withdrawn due to insufficient interest in study participation due to recent approval in this rare condition.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-11', 'studyFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2018-12-17', 'lastUpdatePostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment-emergent adverse events', 'timeFrame': 'Up to 20 weeks', 'description': 'Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Cmax of Parsaclisib', 'timeFrame': 'Up to 6 weeks', 'description': 'Maximum observed concentration.'}, {'measure': 'tmax of Parsaclisib', 'timeFrame': 'Up to 6 weeks', 'description': 'Time to maximum concentration.'}, {'measure': 'Cmin of Parsaclisib', 'timeFrame': 'Up to 6 weeks', 'description': 'Minimum observed concentration over the dose interval.'}, {'measure': 'AUC0-t of Parsaclisib', 'timeFrame': 'Up to 6 weeks', 'description': 'Area under the concentration-time curve from time = 0 to the last measurable concentration at time = t.'}, {'measure': 'CL/F of Parsaclisib', 'timeFrame': 'Up to 6 weeks', 'description': 'Apparent oral dose clearance.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pemphigus vulgaris', 'phosphatidylinositol 3-kinase delta', 'immunoglobulin G autoantibodies'], 'conditions': ['Pemphigus Vulgaris']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of parsaclisib in participants with mild to moderate pemphigus vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinically documented and confirmed diagnosis of pemphigus vulgaris: minimum of 6 months of pemphigus vulgaris diagnosis; positive for anti-desmoglein (DSG)1 or DSG3; Pemphigus Disease Area Index score of 8 to 45 points; active skin, scalp, or mucosal lesions.\n* Disease progression after treatment with standard therapies that are known to confer clinical benefit, or intolerant to treatment; there is no limit to the number of prior treatment regimens.\n* Willingness to avoid pregnancy or fathering children.\n* If required, willing to receive Pneumocystis jirovecii pneumonia prophylaxis during the study period.\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding female.\n* Participants with pemphigus vulgaris who are treatment-naive.\n* Use of protocol-specified medications within defined periods before baseline.\n* Evidence or history of clinically significant infection or protocol-defined medical conditions\n* Laboratory values outside the protocol-defined range at screening.\n* Known or suspected allergy to parsaclisib or any component of the study drug.\n* Known history of clinically significant drug or alcohol abuse in the last year before baseline.\n* Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data."}, 'identificationModule': {'nctId': 'NCT03780166', 'briefTitle': 'A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris', 'orgStudyIdInfo': {'id': 'INCB 50465-208'}, 'secondaryIdInfos': [{'id': 'Parsaclisib', 'type': 'OTHER', 'domain': 'Incyte Corporation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parsaclisib', 'interventionNames': ['Drug: Parsaclisib']}], 'interventions': [{'name': 'Parsaclisib', 'type': 'DRUG', 'otherNames': ['INCB050465'], 'description': 'Parsaclisib administered orally once daily at the cohort-specified dose level.', 'armGroupLabels': ['Parsaclisib']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kathleen Butler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}