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New treatment option for Anemia, Sickle Cell
Official title A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease
ClinicalTrials.gov ID: NCT06481306
What this study is testing
What is BMS-986470?
BMS-986470 is an investigational medicine, being studied as a potential treatment for anemia, sickle cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Cohort A:
- Healthy male and female (who are not of childbearing potential) participants, as determined by the investigator based on medical history and other...
- 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...
- Participants with a documented diagnosis of sickle cell disease (SCD) with genotype HbSS, HbSβ0-thal, or HbSβ+-thal.
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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...
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants must have the following laboratory values: i) 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)...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- La Jolla, California, United States
- Oakland, California, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Lenexa, Kansas, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Greenville, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Greenville, South Carolina, United States
- Fairfax, Virginia, United States
- Richmond, Virginia, United States
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
- Créteil, France
+ 11 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; La Jolla, California, United States; Oakland, California, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.