Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:33 AM
Study NCT ID:
NCT06875960
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2025-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants treated with BMS-986165', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus (SLE)', 'Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06875960.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) who have completed study IM011074 or Study IM011132'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Participants must have completed Study IM011074 or Study IM011132 through the protocol-required treatment period.\n* Participants must be, based on the physician's medical judgement, likely to receive benefit from receiving treatment with deucravacitinib.\n* Participants must have received IP within 60 days of enrollment. Exceptions may be granted based upon consultation with BMS.\n\nExclusion Criteria\n\n* Participants must not have any disease or medical condition that, in the opinion of the physician, would make the subject unsuitable for this protocol, would interfere with the interpretation of subject safety or considered unsuitable by the physician for any other reason.\n* Participants must not have any evidence of active Tuberculosis (TB).\n* Other protocol-defined Inclusion/Exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT06875960', 'briefTitle': 'A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Continuation Protocol for Deucravacitinib in Patients With Patients With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132', 'orgStudyIdInfo': {'id': 'IM011-1263'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Administration of BMS-986165', 'interventionNames': ['Drug: BMS-986165']}], 'interventions': [{'name': 'BMS-986165', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Administration of BMS-986165']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '10155', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amit Saxena, Site 0002', 'role': 'CONTACT', 'phone': '646-501-7387'}], 'facility': 'New York University School Of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0003', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}], 'centralContacts': [{'name': 'BMS Clinical Trials Contact Center www.BMSClinicalTrials.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '855-907-3286'}, {'name': 'First line of the email MUST contain the NCT# and Site#', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'See plan description', 'ipdSharing': 'YES', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html", 'accessCriteria': 'See plan description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}