Phase 2 Sickle Cell Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
Healthy Volunteers (Cohort A):
- People who are generally healthy, as assessed by the study doctor based on medical history and other checks.
- Women who are not able to become pregnant — either because they have not had a period for at least 12 months (with no other medical explanation) and have hormone levels confirming this, or because they have had their uterus, both ovaries, or both fallopian tubes surgically removed.
- People whose body weight is in a healthy range for their height, with a Body Mass Index (BMI) between 18.0 and 32.0.
- People whose physical checks, vital signs, heart tracing (ECG), and blood test results show no significant health concerns.
People with Sickle Cell Disease (Cohort B):
- People with a confirmed diagnosis of sickle cell disease of a specific genetic type: HbSS, HbSβ0-thal, or HbSβ+-thal.
- For one part of the study: people who have had 4 or more painful crises in the past 12 months, or 2 or more in the past 6 months.
- For another part of the study: people who have had between 2 and 15 painful crises in the past 12 months.
- People who are generally able to carry out everyday activities with no or minimal limitations, as rated by a standard health scale (confirm with trial site).
- People whose blood test results fall within specific ranges for red blood cells, white blood cells, platelets, and immature red blood cells (confirm with trial site for exact values).
Who may not be able to join:
Healthy Volunteers (Cohort A):
- People with any significant medical condition, or any condition that could make it hard to interpret the study results.
- People with any condition, including abnormal blood test results, that the study doctor considers would put them at unacceptable risk by joining.
- People who have had major surgery, or have surgery planned, within 12 weeks before the study starts (except certain stomach or bowel surgery).
People with Sickle Cell Disease (Cohort B):
- People with any significant ongoing or serious medical illness, an active or uncontrolled infection, or abnormal blood test results that would put them at unacceptable risk.
- For one part of the study only: people who have had more than 6 severe painful crises requiring at least 24 hours in hospital within the past 12 months.
- For one part of the study only: people who have had a serious lung complication called acute chest syndrome within the past 6 months.
- People whose kidneys are not filtering blood well enough, as measured by a standard formula (confirm with trial site).
Both Groups:
- People who are currently receiving regular red blood cell or platelet transfusions, or who have had a red blood cell transfusion within the past 28 days, or a platelet transfusion within the past 14 days before the study begins.
- Other eligibility criteria set out in the study protocol may also apply (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb
Phone: 855-907-3286
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Number of participants with adverse events (AEs); Number of participants with serious adverse events (SAEs); Number of participants with AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria; Number of participants with AEs leading to discontinuation; Number of deaths; Proportion of participants achieving HbF ≥ 10%; Proportion of participants achieving HbF ≥ 20%; Proportion of participants achieving HbF ≥ 30%
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.