Anemia, Sickle CellPhase 1/2NCT06481306
A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease
A Phase 1/2 study testing BMS-986470, Famotidine and Pantoprazole in people with Anemia, Sickle Cell and Healthy Volunteers, run by Bristol-Myers Squibb at 32 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia, Sickle Cell, Healthy Volunteers
- What is being tested?
- BMS-986470, Famotidine and Pantoprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 32 sitesin 5 countries
- Study dates
- 17 Jul 2024to 16 Nov 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cohort A:
- 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.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/[height (m)]2 as measured at screening.
- 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.
- Cohort B:
- Participants with a documented diagnosis of sickle cell disease (SCD) with genotype HbSS, HbSβ0-thal, or HbSβ+-thal.
Show all 10Show fewer
- For Cohort B Part 1 only: Participants with ≥ 4 vaso-occlusive crises (VOCs) within the previous 12 months or ≥ 2 VOCs within the previous 6 months. For Cohort B Part 2 only: Participants with ≥ 2 VOCs and ≤ 15 VOCs within the previous 12 months.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants must have the following laboratory values:
- Hemoglobin ≥ 5.5 and ≤ 12 g/dL (males) or ≥ 5.5 and ≤ 10.6 g/dL (females). ii) Absolute neutrophil count ≥ 1500/μL. iii) Platelet count ≥ 100 × 10^3/μL. iv) Absolute reticulocyte count > 100 × 10^3/μL or > 50 × 10^3/μL if taking hydroxyurea.
Who cannot join
- Cohort A:
- Any significant medical condition or any condition that confounds the ability to interpret data from the study.
- 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.
- Any major surgery or planned surgery (except GI surgery) within 12 weeks of the first study intervention administration.
- Cohort B:
- 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.
Show all 12Show fewer
- For Cohort B Part 1 only: 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.
- For Cohort B Part 1 only: participants with any episode of acute chest syndrome within the last 6 months prior to the first dose of study intervention.
- Creatinine clearance (CrCl) < 60 mL/min/1.72m2 using Chronic Kidney Disease Epidemiology (CKD-EPI) equation.
- Cohort A and B:
- 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.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
32 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
32 sites in 5 countries
United States19 sites, 18 recruiting
- Recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Fuad El Rassi, Site 0017, 404-778-1350
- Not yet recruiting
Local Institution - 0064
Baltimore, Maryland, 21287
Site 0064
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Julie Kanter, Site 0008, 205-975-2837
- Not yet recruiting
Local Institution - 0024
Boston, Massachusetts, 02114
Site 0024
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Elizabeth Klings, Site 0016, 617-638-8265
- Not yet recruiting
Local Institution - 0034
Chicago, Illinois, 60612
Site 0034
- Not yet recruiting
Local Institution - 0028
Cleveland, Ohio, 44195
Site 0028
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Sheinei Alan, Site 0013, 571-472-4724
- Not yet recruiting
Local Institution - 0033
Greenville, North Carolina, 27834
Site 0033
- Not yet recruiting
Local Institution - 0027
Greenville, South Carolina, 29605
Site 0027
- Recruiting
University of California San Diego - La Jolla
La Jolla, California, 92037
Srila Gopal, Site 0021, 858-822-6276
- Active, not recruiting
Local Institution - 0001
Lenexa, Kansas, 66219
- Recruiting
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Cecelia Calhoun, Site 0022, 000-000-0000
- Recruiting
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
Mark Walters, Site 0003
- Not yet recruiting
Local Institution - 0029
Philadelphia, Pennsylvania, 19104
Site 0029
- Recruiting
Thomas Jefferson University - Medicine/GI and Hepatology
Philadelphia, Pennsylvania, 19107
Sanaa Rizk, Site 0007, 000-000-0000
- Not yet recruiting
Local Institution - 0032
Pittsburgh, Pennsylvania, 15213
Site 0032
- Recruiting
Virginia Commonwealth University (VCU) Medical Center
Richmond, Virginia, 23298
Thokozeni Lipato, Site 0014, 804-828-8870
- Not yet recruiting
Local Institution - 0030
St Louis, Missouri, 63110
Site 0030
United Kingdom5 sites, 5 recruiting
- Recruiting
University Hospitals Sussex NHS Foundation Trust
East Sussex, Brighton And Hove, BN2 1ES
Tom Rider, Site 0004, 01276667758
- Not yet recruiting
Local Institution - 0005
Leeds, LS9 7TF
Site 0005
- Not yet recruiting
Local Institution - 0044
London, Greater London, SE19RT
Site 0044
- Recruiting
King's College Hospital
London, London, City of, SE5 9RL
Moji Awogbade, Site 0006
- Not yet recruiting
Local Institution - 0047
London, W12 0HS
Site 0047
France4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0061
Créteil, 94000
Site 0061
- Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, 13385
Sarah SZEPETOWSKI, Site 0015, 33491386778
- Recruiting
Hôpital Universitaire Necker Enfants Malades
Paris, 75015
Olivier Hermine, Site 0023, +33144495663
- Recruiting
CHU Strasbourg-Hautepierre
Strasbourg, 67098
Shanti AME, Site 0025, +33388116768
Italy3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0011
Milan, Lombardy, 20122
Site 0011
- Not yet recruiting
Local Institution - 0037
Padua, 35128
Site 0037
- Not yet recruiting
Local Institution - 0009
Verona, 37134
Site 0009
Canada1 site, 1 recruiting
- Not yet recruiting
Local Institution - 0050
Vancouver, British Columbia, V621Y6
Site 0050
About this study
Official title: 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
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.
- Conditions
- Anemia, Sickle Cell, Healthy Volunteers
- Being tested
- BMS-986470, Placebo, Famotidine, Pantoprazole
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986470Drug
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
FamotidineDrug
Specified dose on specified days
PantoprazoleDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort A Part 1 | Experimental | Not described Receives: Drug: BMS-986470; Drug: Placebo |
| Cohort A Part 2 | Experimental | Not described Receives: Drug: BMS-986470; Drug: Placebo |
| Cohort A Part 3 | Experimental | Not described Receives: Drug: BMS-986470; Drug: Famotidine; Drug: Pantoprazole |
| Cohort B Part 1 | Experimental | Not described Receives: Drug: BMS-986470; Drug: Placebo |
| Cohort B Part 2 | Experimental | Not described Receives: Drug: BMS-986470 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up to 26 months
Number of participants with serious adverse events (SAEs)
Measured: Up to 26 months
Number of participants with AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria
Measured: Up to 26 months
Number of participants with AEs leading to discontinuation
Measured: Up to 26 months
Number of deaths
Measured: Up to 26 months
Proportion of participants achieving HbF ≥ 10%
Measured: Up to 28 days after last dose
Proportion of participants achieving HbF ≥ 20%
Measured: Up to 28 days after last dose
Proportion of participants achieving HbF ≥ 30%
Measured: Up to 28 days after last dose
Secondary outcomes (25)
Maximum observed plasma concentration (Cmax)
Cohort A Parts 1 and 2 and Cohort B Part 1
Measured: Up to Day 28
Area under the concentration-time curve (AUC)
Cohort A Parts 1 and 2 and Cohort B Part 1
Measured: Up to Day 28
Time of maximum observed plasma concentration (Tmax)
Cohort A Parts 1 and 2 and Cohort B Part 1
Measured: Up to Day 28
Dose proportionality of BMS-986470 for Cmax and AUC
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
Measured: Up to Day 28
Change from baseline in total hemoglobin (Hb)
Cohort A Part 2, Cohort B Parts 1 and 2
Measured: Up to 26 months
Change from baseline in total Hb fractions: adult Hb (HbA)
Cohort A Part 2
Measured: Up to Day 28
Change from baseline in total Hb fractions: fetal Hb (HbF)
Cohort A Part 2, Cohort B Parts 1 and 2
Measured: Up to 26 months
Change from baseline in total Hb fractions: sickle Hb (HbS)
Cohort B
Measured: Up to 26 months
Change from baseline in markers of red blood cell (RBC) lysis: total Hb
Cohort B
Measured: Up to 26 months
Change from baseline in markers of RBC lysis: aspartate aminotransferase (AST)
Cohort B
Measured: Up to 26 months
Change from baseline in markers of RBC lysis: lactate dehydrogenase (LDH)
Cohort B
Measured: Up to 26 months
Change from baseline in markers of RBC lysis: total bilirubin
Cohort B
Measured: Up to 26 months
Change from baseline in markers of RBC lysis: indirect bilirubin
Cohort B
Measured: Up to 26 months
Change from baseline in markers of RBC lysis: haptoglobin
Cohort B
Measured: Up to 26 months
Change from baseline in markers of RBC lysis: absolute reticulocyte count
Cohort B
Measured: Up to 26 months
Change from baseline in markers of RBC lysis: reticulocyte percentage of RBCs
Cohort B
Measured: Up to 26 months
Number of participants achieving HbF ≥ 10%
Cohort B
Measured: Up to 26 months
Median time to achieve HbF ≥ 10%
Cohort B
Measured: Up to 26 months
Median duration of HbF at or above 10%
Cohort B
Measured: Up to 26 months
Number of participants achieving HbF ≥ 20%
Cohort B
Measured: Up to 26 months
Median time to achieve HbF ≥ 20%
Cohort B
Measured: Up to 26 months
Median duration of HbF at or above 20%
Cohort B
Measured: Up to 26 months
Number of participants achieving HbF ≥ 30%
Cohort B
Measured: Up to 26 months
Median time to achieve HbF ≥ 30%
Cohort B
Measured: Up to 26 months
Median duration of HbF at or above 30%
Cohort B
Measured: Up to 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start17 Jul 2024
- Primary completion6 Jan 2027 (estimated)
- Study completion16 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481306
- Sponsor's protocol ID
- CA230-1019
- Other IDs
- 2023-510283-12, U1111-1301-6753, 2023
- Status last verified
- Aug 2026
- First submitted
- 25 Jun 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06481306
- Acronym / sponsor ID
- CA230-1019
- Conditions
- Anemia, Sickle Cell, Healthy Volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 6 Jan 2027 (estimated)
- Study completion
- 16 Nov 2027 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A Part 1 | Experimental | Drug: BMS-986470, Drug: Placebo |
| Cohort A Part 2 | Experimental | Drug: BMS-986470, Drug: Placebo |
| Cohort A Part 3 | Experimental | Drug: BMS-986470, Drug: Famotidine, Drug: Pantoprazole |
| Cohort B Part 1 | Experimental | Drug: BMS-986470, Drug: Placebo |
| Cohort B Part 2 | Experimental | Drug: BMS-986470 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/[height (m)]2 as measured at screening.
- 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.
- Participants with a documented diagnosis of sickle cell disease (SCD) with genotype HbSS, HbSβ0-thal, or HbSβ+-thal.
- For Cohort B Part 1 only: Participants with ≥ 4 vaso-occlusive crises (VOCs) within the previous 12 months or ≥ 2 VOCs within the previous 6 months. For Cohort B Part 2 only: Participants with ≥ 2 VOCs and ≤ 15 VOCs within the previous 12 months.
Key exclusion criteria (12 listed)
- Any significant medical condition or any condition that confounds the ability to interpret data from the study.
- 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.
- Any major surgery or planned surgery (except GI surgery) within 12 weeks of the first study intervention administration.
- 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.
- For Cohort B Part 1 only: 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986470Specified dose on specified days | Drug | Cohort A Part 1, Cohort A Part 2, Cohort A Part 3, Cohort B Part 1, Cohort B Part 2 |
| PlaceboSpecified dose on specified days | Drug | Cohort A Part 1, Cohort A Part 2, Cohort B Part 1 |
| FamotidineSpecified dose on specified days | Drug | Cohort A Part 3 |
| PantoprazoleSpecified dose on specified days | Drug | Cohort A Part 3 |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 26 months
Number of participants with serious adverse events (SAEs)
Time frame: Up to 26 months
Number of participants with AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria
Time frame: Up to 26 months
Number of participants with AEs leading to discontinuation
Time frame: Up to 26 months
Number of deaths
Time frame: Up to 26 months
Proportion of participants achieving HbF ≥ 10%
Time frame: Up to 28 days after last dose
Proportion of participants achieving HbF ≥ 20%
Time frame: Up to 28 days after last dose
Proportion of participants achieving HbF ≥ 30%
Time frame: Up to 28 days after last dose
25 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 28
Area under the concentration-time curve (AUC)
Time frame: Up to Day 28
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 28
Dose proportionality of BMS-986470 for Cmax and AUC
Time frame: Up to Day 28
Change from baseline in total hemoglobin (Hb)
Time frame: Up to 26 months
Change from baseline in total Hb fractions: adult Hb (HbA)
Time frame: Up to Day 28
Change from baseline in total Hb fractions: fetal Hb (HbF)
Time frame: Up to 26 months
Change from baseline in total Hb fractions: sickle Hb (HbS)
Time frame: Up to 26 months
Change from baseline in markers of red blood cell (RBC) lysis: total Hb
Time frame: Up to 26 months
Change from baseline in markers of RBC lysis: aspartate aminotransferase (AST)
Time frame: Up to 26 months
Change from baseline in markers of RBC lysis: lactate dehydrogenase (LDH)
Time frame: Up to 26 months
Change from baseline in markers of RBC lysis: total bilirubin
Time frame: Up to 26 months
Change from baseline in markers of RBC lysis: indirect bilirubin
Time frame: Up to 26 months
Change from baseline in markers of RBC lysis: haptoglobin
Time frame: Up to 26 months
Change from baseline in markers of RBC lysis: absolute reticulocyte count
Time frame: Up to 26 months
Change from baseline in markers of RBC lysis: reticulocyte percentage of RBCs
Time frame: Up to 26 months
Number of participants achieving HbF ≥ 10%
Time frame: Up to 26 months
Median time to achieve HbF ≥ 10%
Time frame: Up to 26 months
Median duration of HbF at or above 10%
Time frame: Up to 26 months
Number of participants achieving HbF ≥ 20%
Time frame: Up to 26 months
Median time to achieve HbF ≥ 20%
Time frame: Up to 26 months
Median duration of HbF at or above 20%
Time frame: Up to 26 months
Number of participants achieving HbF ≥ 30%
Time frame: Up to 26 months
Median time to achieve HbF ≥ 30%
Time frame: Up to 26 months
Median duration of HbF at or above 30%
Time frame: Up to 26 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
32 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986470, Famotidine and Pantoprazole in people with Anemia, Sickle Cell and Healthy Volunteers, run by Bristol-Myers Squibb at 32 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, United Kingdom, France, Italy, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: Up to 26 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.