BMS-986470 for Sickle Cell Disease

Recruiting at 15 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bristol-Myers Squibb

Must be taking: Hydroxyurea

Disqualifiers: Severe VOCs, Acute chest syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

184 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are receiving regular blood transfusions, you may not be eligible to participate.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

Inclusion Criteria

I have Sickle Cell Disease with a specific genotype.

My organs are functioning normally.

Cohort A: BMI of 18.0 to 32.0 kg/m^2

Exclusion Criteria

I have had severe pain crises or lung-related complications.

Cohort B: Creatinine clearance < 60 mL/min/1.72m2

Cohort A: Any significant medical condition or condition confounding data interpretation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986470 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics

4 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

22 weeks

Regular visits (in-person)

Treatment Details

Interventions

• BMS-986470

Trial Overview 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.

Participant Groups

Group I: Cohort B Part 2 Experimental Treatment 1 Intervention

Group II: Cohort B Part 1 Experimental Treatment 2 Interventions

Group III: Cohort A Part 3 Experimental Treatment 1 Intervention

Group IV: Cohort A Part 2 Experimental Treatment 2 Interventions

Group V: Cohort A Part 1 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania