Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-03-03 @ 12:24 PM
Study NCT ID:
NCT06481306
Status:
RECRUITING
Last Update Posted:
2025-10-31
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015738', 'term': 'Famotidine'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-11-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-30', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 26 months'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'Up to 26 months'}, {'measure': 'Number of participants with AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria', 'timeFrame': 'Up to 26 months'}, {'measure': 'Number of participants with AEs leading to discontinuation', 'timeFrame': 'Up to 26 months'}, {'measure': 'Number of deaths', 'timeFrame': 'Up to 26 months'}], 'secondaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to Day 28', 'description': 'Cohort A Parts 1 and 2 and Cohort B Part 1'}, {'measure': 'Area under the concentration-time curve (AUC)', 'timeFrame': 'Up to Day 28', 'description': 'Cohort A Parts 1 and 2 and Cohort B Part 1'}, {'measure': 'Time of maximum observed plasma concentration (Tmax)', 'timeFrame': 'Up to Day 28', 'description': 'Cohort A Parts 1 and 2 and Cohort B Part 1'}, {'measure': 'Dose proportionality of BMS-986470 for Cmax and AUC', 'timeFrame': 'Up to Day 28', 'description': 'Assessed by using the slope of a statistical linear relationship between the ln-transformed PK parameters AUC and Cmax and the ln-transformed dose will be fitted by using power model'}, {'measure': 'Change from baseline in total hemoglobin (Hb)', 'timeFrame': 'Up to 26 months', 'description': 'Cohort A Part 2, Cohort B Parts 1 and 2'}, {'measure': 'Change from baseline in total Hb fractions: adult Hb (HbA)', 'timeFrame': 'Up to Day 28', 'description': 'Cohort A Part 2'}, {'measure': 'Change from baseline in total Hb fractions: fetal Hb (HbF)', 'timeFrame': 'Up to 26 months', 'description': 'Cohort A Part 2, Cohort B Parts 1 and 2'}, {'measure': 'Change from baseline in total Hb fractions: sickle Hb (HbS)', 'timeFrame': 'Up to 26 months', 'description': 'Cohort B'}, {'measure': 'Change from baseline in markers of red blood cell (RBC) lysis: total Hb', 'timeFrame': 'Up to 26 months', 'description': 'Cohort B'}, {'measure': 'Change from baseline in markers of RBC lysis: aspartate aminotransferase (AST)', 'timeFrame': 'Up to 26 months', 'description': 'Cohort B'}, {'measure': 'Change from baseline in markers of RBC lysis: lactate dehydrogenase (LDH)', 'timeFrame': 'Up to 26 months', 'description': 'Cohort B'}, {'measure': 'Change from baseline in markers of RBC lysis: total bilirubin', 'timeFrame': 'Up to 26 months', 'description': 'Cohort B'}, {'measure': 'Change from baseline in markers of RBC lysis: indirect bilirubin', 'timeFrame': 'Up to 26 months', 'description': 'Cohort B'}, {'measure': 'Change from baseline in markers of RBC lysis: haptoglobin', 'timeFrame': 'Up to 26 months', 'description': 'Cohort B'}, {'measure': 'Change from baseline in markers of RBC lysis: absolute reticulocyte count', 'timeFrame': 'Up to 26 months', 'description': 'Cohort B'}, {'measure': 'Change from baseline in markers of RBC lysis: reticulocyte percentage of RBCs', 'timeFrame': 'Up to 26 months', 'description': 'Cohort B'}, {'measure': 'Number of participants achieving HbF ≥ 10%', 'timeFrame': 'Up to 26 months', 'description': 'Cohort B'}, {'measure': 'Number of participants achieving HbF ≥ 20%', 'timeFrame': 'Up to 26 months', 'description': 'Cohort B'}, {'measure': 'Number of participants achieving HbF ≥ 30%', 'timeFrame': 'Up to 26 months', 'description': 'Cohort B'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia, Sickle Cell', 'Healthy Volunteers']}, '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/NCT06481306.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, pH and food effect, and preliminary efficacy of BMS-986470 in healthy volunteers and participants with sickle cell disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n\\- Cohort A.\n\ni) Healthy male and female (who are not of childbearing potential) participants, as determined by the investigator based on medical history and other determinations. Females not of childbearing potential must have been amenorrhoeic for at least 12 months without an alternative medical cause and have follicle-stimulating hormone (FSH) levels of at least 40 IU/L or have undergone a hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.\n\nii) Body mass index (BMI) of 18.0 to 32.0 kg/m\\^2, inclusive. BMI = weight (kg)/ (height \\[m\\])\\^2 as measured at screening.\n\niii) No evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory assessments beyond what is consistent with the target population.\n\n\\- Cohort B.\n\ni) Participants with a documented diagnosis of Sickle Cell Disease (SCD) with genotype HbSS, HbSβ0-thal, or HbSβ+-thal.\n\nii) Participants with ≥ 4 vaso-occlusive crises (VOCs) within the previous 12 months or ≥ 2 VOCs within the previous 6 months.\n\niii) Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\niv) Must have the following laboratory values:.\n\nA. Hemoglobin ≥ 5.5 and ≤ 12 g/dL (males) or ≥ 5.5 and ≤ 10.6 g/dL (females).\n\nB. Absolute neutrophil count ≥ 1500/μL.\n\nC. Platelet count ≥ 100 × 10\\^3/μL.\n\nD. Absolute reticulocyte count \\> 100 × 10\\^3/μL or \\> 50 × 10\\^3/μL if taking hydroxyurea.\n\nExclusion Criteria\n\n\\- Cohort A.\n\ni) Any significant medical condition or any condition that confounds the ability to interpret data from the study.\n\nii) Participant has any condition, including the presence of laboratory abnormalities, that places the participant at unacceptable risk if the participant was to participate in the study.\n\niii) Any major surgery or planned surgery (except GI surgery) within 12 weeks of the first study intervention administration.\n\n\\- Cohort B.\n\ni) Participants with any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.\n\nii) Participants with more than 6 severe VOCs defined as VOCs requiring ≥ 24 hours of hospital admission within 12 months prior to the first dose of study intervention or any VOC requiring ≥ 24 hours of hospital admission within 30 days prior to the first dose of study intervention.\n\niii) Participants with any episode of acute chest syndrome within the last 6 months prior to the first dose of study intervention.\n\niv) Creatinine clearance (CrCl) \\< 60 mL/min/1.72m2 using Chronic Kidney Disease Epidemiology (CKD-EPI) equation\n\n* Cohort A and B.\n\n i) Participant is receiving regularly scheduled RBC or platelet transfusions or has received a RBC transfusion within 28 days and a platelet transfusion within 14 days prior to starting treatment with BMS-986470.\n* Other protocol-defined Inclusion/Exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06481306', 'briefTitle': 'A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1/2a, First-in-human, Randomized, Double-blinded, Placebo-controlled, Dose-finding Study in Healthy Volunteers and Participants With Sickle Cell Disease to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, pH and Food Effect, and Preliminary Efficacy of BMS-986470', 'orgStudyIdInfo': {'id': 'CA230-1019'}, 'secondaryIdInfos': [{'id': '2023-510283-12', 'type': 'OTHER', 'domain': 'EU CTR'}, {'id': 'U1111-1301-6753', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A Part 1', 'interventionNames': ['Drug: BMS-986470', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A Part 2', 'interventionNames': ['Drug: BMS-986470', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A Part 3', 'interventionNames': ['Drug: BMS-986470', 'Drug: Famotidine']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B Part 1', 'interventionNames': ['Drug: BMS-986470', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B Part 2', 'interventionNames': ['Drug: BMS-986470']}], 'interventions': [{'name': 'BMS-986470', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort A Part 1', 'Cohort A Part 2', 'Cohort A Part 3', 'Cohort B Part 1', 'Cohort B Part 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort A Part 1', 'Cohort A Part 2', 'Cohort B Part 1']}, {'name': 'Famotidine', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort A Part 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie Kanter, Site 0008', 'role': 'CONTACT', 'phone': '205-975-2837'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0021', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0021', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0003', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0003', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cecelia Calhoun, Site 0022', 'role': 'CONTACT', 'phone': '000-000-0000'}], 'facility': 'Yale-New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0017', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0017', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0034', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0034', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0024', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0024', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Klings, Site 0016', 'role': 'CONTACT', 'phone': '617-638-8265'}], 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sanaa Rizk, Site 0007', 'role': 'CONTACT', 'phone': '000-000-0000'}], 'facility': 'Thomas Jefferson University - Medicine/GI and Hepatology', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0032', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0032', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sheinei Alan, Site 0013', 'role': 'CONTACT', 'phone': '571-472-4724'}], 'facility': 'Inova Schar Cancer Institute', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wally Smith, Site 0014', 'role': 'CONTACT', 'phone': '804-828-0951'}], 'facility': 'Virginia Commonwealth University (VCU) Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '67033', 'city': 'Strasbourg', 'state': 'Alsace', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Shanti AME, Site 0025', 'role': 'CONTACT', 'phone': '0368767401'}], 'facility': 'Institut de cancérologie Strasbourg Europe (ICANS)', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '13385', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sarah SZEPETOWSKI, Site 0015', 'role': 'CONTACT', 'phone': '33491386778'}], 'facility': 'Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Hermine, Site 0023', 'role': 'CONTACT', 'phone': '+33144495663'}], 'facility': 'Hôpital Universitaire Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'BN2 1ES', 'city': 'East Sussex', 'state': 'Brighton And Hove', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Site 0004', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0004'}, {'zip': 'SE5 9RL', 'city': 'London', 'state': 'London, City of', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Moji Awogbade, Site 0006', 'role': 'CONTACT'}], 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Site 0005', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0005', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], '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', '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.\n\nAdditional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:\n\nhttps://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html", 'accessCriteria': 'See Plan Description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}