Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 11:15 AM
Study NCT ID:
NCT07412704
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-09-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to Week 54'}, {'measure': 'Number of participants with Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Week 54'}], 'secondaryOutcomes': [{'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'Up to Week 54'}, {'measure': 'Time of maximum observed concentration (Tmax)', 'timeFrame': 'Up to Week 54'}, {'measure': 'area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))', 'timeFrame': 'Up to Week 54'}, {'measure': 'Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF))', 'timeFrame': 'Up to Week 54'}, {'measure': 'Apparent terminal serum half-life (T-HALF)', 'timeFrame': 'Up to Week 54'}, {'measure': 'Apparent total body clearance (CLT/F)', 'timeFrame': 'Up to Week 54'}, {'measure': 'Apparent volume of distribution of terminal phase (Vz/F)', 'timeFrame': 'Up to Week 54'}, {'measure': 'Change from baseline in numbers and fractions of B cells', 'timeFrame': 'Up to Week 54'}, {'measure': 'Change from baseline in immunoglobulin G (igG) levels', 'timeFrame': 'Up to Week 54'}, {'measure': 'Change from baseline in igM levels', 'timeFrame': 'Up to Week 54'}, {'measure': 'Change from baseline in igE levels', 'timeFrame': 'Up to Week 54'}, {'measure': 'Change from baseline in igD levels', 'timeFrame': 'Up to Week 54'}, {'measure': 'Change from baseline in igA levels', 'timeFrame': 'Up to Week 54'}, {'measure': 'Number of participants with anti-drug antibody (ADA)', 'timeFrame': 'Up to Week 54'}, {'measure': 'Change from baseline in disease activity score 28-C-reactive protein (DAS28-CRP)', 'timeFrame': 'At Week 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis, Rheumatoid']}, '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', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary evidence of disease-modifying effect of BMS-986528 in participants with refractory, difficult-to-treat rheumatoid arthritis (RA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n\\- Adult participants with rheumatoid arthritis (RA) who meet definition of difficult-to-treat.\n\nExclusion Criteria\n\n* Juvenile arthritis or onset of inflammatory arthritis before age 18.\n* Seronegative RA participants in whom polymyalgia rheumatica has not been ruled out.\n* Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment.\n* Other protocol-defined Inclusion/Exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT07412704', 'briefTitle': 'A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1/2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants With Refractory Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'IM062-0001'}, 'secondaryIdInfos': [{'id': '2025-520666-22', 'type': 'OTHER', 'domain': 'EU CTR'}, {'id': 'U1111-1317-6393', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A1', 'interventionNames': ['Drug: BMS-986528']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A2', 'interventionNames': ['Drug: BMS-986528']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A3', 'interventionNames': ['Drug: BMS-986528']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A4', 'interventionNames': ['Drug: BMS-986528']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A5', 'interventionNames': ['Drug: BMS-986528']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A6', 'interventionNames': ['Drug: BMS-986528']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A7', 'interventionNames': ['Drug: BMS-986528']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A8', 'interventionNames': ['Drug: BMS-986528']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B1', 'interventionNames': ['Drug: BMS-986528']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B2', 'interventionNames': ['Drug: BMS-986528']}], 'interventions': [{'name': 'BMS-986528', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort A1', 'Cohort A2', 'Cohort A3', 'Cohort A4', 'Cohort A5', 'Cohort A6', 'Cohort A7', 'Cohort A8', 'Cohort B1', 'Cohort B2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'contacts': [{'name': 'Site 0050', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0050', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Site 0055', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0055', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'contacts': [{'name': 'Site 0066', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0066', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75115', 'city': 'DeSoto', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution - 0051', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Site 0057', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0057', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '2170', 'city': 'Merksem', 'state': 'Flanders', 'country': 'Belgium', 'contacts': [{'name': 'Site 0048', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0048', 'geoPoint': {'lat': 51.24623, 'lon': 4.44903}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'contacts': [{'name': 'Site 0049', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0049', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '100091', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Site 0006', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0006', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Site 0010', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0010', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'contacts': [{'name': 'Site 0007', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0007', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Site 0020', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0020', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Site 0001', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '81377', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'contacts': [{'name': 'Site 0040', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0040', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '48324', 'city': 'Sendenhorst', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'contacts': [{'name': 'Site 0056', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0056', 'geoPoint': {'lat': 51.84303, 'lon': 7.82996}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'contacts': [{'name': 'Site 0022', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0022', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'contacts': [{'name': 'Site 0021', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0021', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '44652', 'city': 'Herne', 'country': 'Germany', 'contacts': [{'name': 'Site 0028', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0028', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'zip': '14467', 'city': 'Potsdam', 'country': 'Germany', 'contacts': [{'name': 'Site 0065', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0065', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'zip': '1085', 'city': 'Budapest', 'country': 'Hungary', 'contacts': [{'name': 'Site 0045', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0045', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'country': 'Italy', 'contacts': [{'name': 'Site 0019', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0019', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'contacts': [{'name': 'Site 0017', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0017', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '05-410', 'city': 'Józefów', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'contacts': [{'name': 'Site 0023', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0023', 'geoPoint': {'lat': 52.13707, 'lon': 21.23589}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'A Coruña [La Coruña]', 'country': 'Spain', 'contacts': [{'name': 'Site 0039', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0039', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '14004', 'city': 'Córdoba', 'state': 'Córdoba', 'country': 'Spain', 'contacts': [{'name': 'Site 0058', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0058', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'contacts': [{'name': 'Site 0037', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0037', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'contacts': [{'name': 'Site 0027', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0027', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '76008', 'city': 'Ivano-Frankivsk', 'state': 'Ivano-Frankivsk Oblast', 'country': 'Ukraine', 'contacts': [{'name': 'Site 0060', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0060', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '01135', 'city': 'Kyiv', 'state': 'Kyiv Oblast', 'country': 'Ukraine', 'contacts': [{'name': 'Site 0064', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0064'}, {'zip': '36011', 'city': 'Poltava', 'state': 'Poltava Oblast', 'country': 'Ukraine', 'contacts': [{'name': 'Site 0063', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0063', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}, {'zip': '02000', 'city': 'Kyiv', 'country': 'Ukraine', 'contacts': [{'name': 'Site 0062', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0062', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '46002', 'city': 'Ternopil', 'country': 'Ukraine', 'contacts': [{'name': 'Site 0061', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0061', 'geoPoint': {'lat': 49.55404, 'lon': 25.59067}}], '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 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.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], '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.html", 'accessCriteria': 'See Plan Description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}