Clinical trial 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?
An investigational medicine being studied as a potential treatment for anemia and sickle cell disease.
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 study looks at safety, how the body handles the drug, food effects, and early signs it might help sickle cell disease.
- Who it's for
- Adults who are healthy or who have sickle cell disease.
- What's involved
- Participants will receive the study drug and have regular check‑ups, blood draws, and other safety tests.
- 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
- 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.
- 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.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You likely can't join if
- 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...
- 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...
- 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...
- Participant is receiving regularly scheduled RBC or platelet transfusions or has received a RBC transfusion within 28 days and a platelet transfusion...
See the full eligibility criteria
- Healthy male and female (who are not of childbearing potential) participants, as determined by the investigator based on medical history and other determinations.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/[height (m)]2 as measured at screening.
- 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.
- 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.
- 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.
- 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.
- 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 is enrolling
- Birmingham, Alabama, United States
- La Jolla, California, United States
- Oakland, California, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Philadelphia, Pennsylvania, United States
- Fairfax, Virginia, United States
- Richmond, Virginia, United States
- Marseille, France
- Paris, France
- Strasbourg, France
- East Sussex, Brighton And Hove, United Kingdom
- London, London, City of, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Birmingham, Alabama, United States; La Jolla, California, United States; Oakland, California, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States and 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.