Ignite Creation Date:
2025-12-17 @ 2:48 PM
Ignite Modification Date:
2025-12-23 @ 10:40 PM
Study NCT ID:
NCT06013995
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2023-08-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008179', 'term': 'Lupus Erythematosus, Discoid'}, {'id': 'D008178', 'term': 'Lupus Erythematosus, Cutaneous'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2023-08-23', 'studyFirstSubmitQcDate': '2023-08-23', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 228 days'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'Up to 228 days'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to 228 days'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 228 days'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 228 days'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to 228 days'}], 'secondaryOutcomes': [{'measure': 'Maximum observed serum concentration (Cmax)', 'timeFrame': 'Predose and post-dose up to Day 167'}, {'measure': 'Time of Cmax (Tmax)', 'timeFrame': 'Predose and post-dose up to Day 167'}, {'measure': 'Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])', 'timeFrame': 'Predose and post-dose up to Day 167'}, {'measure': 'Serum PK parameters such as AUC(TAU)', 'timeFrame': 'Predose and post-dose up to Day 167'}, {'measure': 'Change from baseline in regulatory T cells (Treg) count to Day 144', 'timeFrame': 'Baseline up to Day 144'}, {'measure': 'Change from baseline in Treg-to-conventional t cells (Tconv) ratio', 'timeFrame': 'Baseline up to Day 144'}, {'measure': 'Number of participants with anti-drug antibodies', 'timeFrame': 'Baseline up to Day 167'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'BMS-986326', 'Cutaneous Lupus', 'discoid lupus erythematosus (DLE)', 'subacute cutaneous lupus erythematosus (SCLE)', 'Systemic lupus erythematosus (SLE)'], 'conditions': ['Lupus']}, '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/NCT06013995.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous (IV) infusion or subcutaneous (SC) injection, in participants with different forms of lupus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a diagnosis of Discoid Lupus Erythematosus (DLE), Subacute Cutaneous Lupus Erythematosus (SCLE), or Systemic Lupus Erythematosus (SLE).\n* Participants with DLE or SCLE must have their diagnosis at least 3 months prior to screening and must be confirmed by biopsy (except if only the facial/head/neck region is affected) and must have some ongoing disease activity (based CLASI-A scoring).\n* Participants with SLE must have a diagnosis of SLE at screening based on the 2019 EULAR/ACR Classification for SLE and have mild-moderate disease severity (based on a SLEDAI-2K score).\n\nExclusion criteria:\n\n* SLE that is considered by the Investigator to be severe.\n* Drug-induced CLE and drug-induced SLE.\n* Women who are pregnant or breastfeeding.\n* Current use of \\>10 mg prednisone (or equivalent) per day.\n\nNote: Other protocol-defined inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06013995', 'briefTitle': 'A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986326 in Adult Participants With Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'IM034-1000'}, 'secondaryIdInfos': [{'id': '2022-503009-39', 'type': 'OTHER', 'domain': 'EU CTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A: BMS-986326 Dose 1 IV', 'interventionNames': ['Drug: BMS-986326', 'Other: Placebo for BMS-986326']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B: BMS-986326 Dose 2 IV', 'interventionNames': ['Drug: BMS-986326', 'Other: Placebo for BMS-986326']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C1: BMS-986326 Dose 3 IV', 'interventionNames': ['Drug: BMS-986326', 'Other: Placebo for BMS-986326']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C2: BMS-986326 Dose 3 SC', 'interventionNames': ['Drug: BMS-986326', 'Other: Placebo for BMS-986326']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort D2: BMS-986326 Dose 4 SC', 'interventionNames': ['Drug: BMS-986326', 'Other: Placebo for BMS-986326']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort E2: BMS-986326 Dose 3 SC', 'interventionNames': ['Drug: BMS-986326', 'Other: Placebo for BMS-986326']}], 'interventions': [{'name': 'BMS-986326', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort A: BMS-986326 Dose 1 IV', 'Cohort B: BMS-986326 Dose 2 IV', 'Cohort C1: BMS-986326 Dose 3 IV', 'Cohort C2: BMS-986326 Dose 3 SC', 'Cohort D2: BMS-986326 Dose 4 SC', 'Cohort E2: BMS-986326 Dose 3 SC']}, {'name': 'Placebo for BMS-986326', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort A: BMS-986326 Dose 1 IV', 'Cohort B: BMS-986326 Dose 2 IV', 'Cohort C1: BMS-986326 Dose 3 IV', 'Cohort C2: BMS-986326 Dose 3 SC', 'Cohort D2: BMS-986326 Dose 4 SC', 'Cohort E2: BMS-986326 Dose 3 SC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92108', 'city': 'San Diego', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Local Institution - 0048', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Levin, Site 0055', 'role': 'CONTACT', 'phone': '727-466-0078'}], 'facility': 'Clinical Research of West Florida, Inc. (Clearwater)', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Carter, Site 0029', 'role': 'CONTACT', 'phone': '813-870-1292'}], 'facility': 'Clinical Research of West Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30046', 'city': 'Lawrenceville', 'state': 'Georgia', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'North Georgia Rheumatology', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leon Kircik, Site 0061', 'role': 'CONTACT', 'phone': '502-451-9000'}], 'facility': 'Skin Sciences', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Local Institution - 0062', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Local Institution - 0005', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '75013', 'city': 'Allen', 'state': 'Texas', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Allen Arthritis', 'geoPoint': {'lat': 33.10317, 'lon': -96.67055}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Metroplex Clinical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Howard Kenney, Site 0034', 'role': 'CONTACT', 'phone': '509-838-6500'}], 'facility': 'Arthritis Northwest, PLLC', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '1629', 'city': 'Pilar', 'state': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Pablo Maid, Site 0070', 'role': 'CONTACT', 'phone': '0000000000'}], 'facility': 'Hospital Universitario Austral', 'geoPoint': {'lat': -34.45867, 'lon': -58.91398}}, {'zip': '1430', 'city': 'CABA', 'state': 'Buenos Aires F.D.', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Federico Ariel, Site 0075', 'role': 'CONTACT', 'phone': '+5491124691447'}], 'facility': 'Clinica Adventista Belgrano'}, {'zip': '1618', 'city': 'Sofia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Bulgaria', 'facility': 'Local Institution - 0072', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '10117', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stanislav Ignatenko, Site 0044', 'role': 'CONTACT', 'phone': '4930450539200'}], 'facility': 'Charité Research Organisation', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '06847', 'city': 'Dessau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christos Zouboulis, Site 0071', 'role': 'CONTACT', 'phone': '555-555-5562'}], 'facility': 'Städtisches Klinikum Dessau', 'geoPoint': {'lat': 51.83864, 'lon': 12.24555}}, {'zip': '01307', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Susanne Abraham, Site 0047', 'role': 'CONTACT', 'phone': '+493514583401'}], 'facility': 'Universitaetsklinikum Carl Gustav Carus Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '06100', 'city': 'Cuauhtémoc, Ciudad de México', 'state': 'DIF', 'status': 'WITHDRAWN', 'country': 'Mexico', 'facility': 'Local Institution - 0073'}, {'zip': '07760', 'city': 'Mexico City', 'state': 'DIF', 'status': 'WITHDRAWN', 'country': 'Mexico', 'facility': 'Local Institution - 0068', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '31217', 'city': 'Chihuahua City', 'status': 'WITHDRAWN', 'country': 'Mexico', 'facility': 'Local Institution - 0077', 'geoPoint': {'lat': 28.63528, 'lon': -106.08889}}, {'zip': '2333 CL', 'city': 'Leiden', 'status': 'COMPLETED', 'country': 'Netherlands', 'facility': 'Local Institution - 0051', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '02-953', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Bartlomiej Kwiek, Site 0069', 'role': 'CONTACT', 'phone': '+48 608 307 575'}], 'facility': 'Klinika Ambroziak Dermatologia', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '61-848', 'city': 'Poznan', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Aleksandra Danczak-Pazdrowska, Site 0074', 'role': 'CONTACT', 'phone': '48 618549265'}], 'facility': 'Uniwersytecki Szpital Kliniczny w Poznaniu', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '11658', 'city': 'Bucharest', 'state': 'București', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Mihai Abobului, Site 0065', 'role': 'CONTACT', 'phone': '0040766412427'}], 'facility': 'ARENSIA Exploratory Medicine', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400006', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Daniela Fodor, Site 0064', 'role': 'CONTACT', 'phone': '0040735888506'}], 'facility': 'ARENSIA Exploratory Medicine', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'A Coruña [La Coruña]', 'status': 'COMPLETED', 'country': 'Spain', 'facility': 'Local Institution - 0046', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '14004', 'city': 'Córdoba', 'status': 'COMPLETED', 'country': 'Spain', 'facility': 'Local Institution - 0045', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}], 'centralContacts': [{'name': 'BMS Study Connect Contact Center www.BMSStudyConnect.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': {'ipdSharing': 'NO', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers 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"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}