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BMS-986470 for Sickle Cell Disease

Phase 1 & 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohort A: Healthy male and female participants not of childbearing potential with specific criteria for females
Cohort B: Participants with Sickle Cell Disease (SCD) with specific genotypes
Must not have
Cohort B: Participants with a history of severe VOCs or acute chest syndrome
Cohort A and B: Participant receiving or recently received RBC or platelet transfusions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 154

Summary

"This trial will assess how safe and well-tolerated BMS-986470 is, how the body processes and responds to it, how it interacts with pH levels and food, and its initial effectiveness

Who is the study for?
This trial is for healthy individuals and those with sickle cell disease. Participants must meet specific health criteria to join, but the exact inclusion and exclusion details are not provided.
What is being tested?
The study is testing BMS-986470's safety, how it affects the body (pharmacokinetics/dynamics), its behavior in different pH levels and after food intake, as well as its initial effectiveness in treating sickle cell disease compared to a placebo.
What are the potential side effects?
Specific side effects of BMS-986470 are not listed, but generally may include reactions at the drug administration site, potential changes in blood chemistry or physical discomforts that will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy adult not able to have children, meeting specific criteria if female.
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I have Sickle Cell Disease with a specific genotype.
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My organs are functioning normally.
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I am very active or have minor limitations in physical activity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had severe pain crises or lung-related complications.
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I have recently had a blood or platelet transfusion.
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I had major surgery less than 12 weeks ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 154
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 154 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Area under the concentration-time curve (AUC)
Change from baseline in markers of RBC lysis: absolute reticulocyte count
Change from baseline in markers of RBC lysis: absolute schistocyte count
+18 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort B Part 2Experimental Treatment1 Intervention
Group II: Cohort B Part 1Experimental Treatment2 Interventions
Group III: Cohort A Part 3Experimental Treatment1 Intervention
Group IV: Cohort A Part 2Experimental Treatment2 Interventions
Group V: Cohort A Part 1Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,686 Previous Clinical Trials
4,129,677 Total Patients Enrolled
~123 spots leftby Jan 2027
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