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Looking for participantsPhase1/Phase2

A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease

Sponsor: Bristol-Myers Squibb

NCT ID: NCT06481306

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
BMS-986470 (drug), Placebo (drug), Famotidine (drug), Pantoprazole (drug)
How long the study runs
Study runs about 40 months (dates as stated)
About the drug or intervention
BMS-986470 — drug: Specified dose on specified days · Placebo — drug: Specified dose on specified days · Famotidine — drug: Specified dose on specified days · Pantoprazole — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by Bristol-Myers Squibb, is testing a new medicine called BMS-986470. It will include healthy volunteers (Cohort A) and people with sickle cell disease (Cohort B).

Who can take part

  • Cohort A: healthy men and women who cannot become pregnant, with a body mass index between 18.0 and 32.0
  • Cohort A: no signs of organ problems or major changes in checks of the heart, vital signs or blood tests
  • Cohort B: a confirmed diagnosis of sickle cell disease with certain genetic types (HbSS, HbSβ0-thal or HbSβ+-thal)
  • Cohort B Part 1: a certain number of pain crises (vaso-occlusive crises) in the past year or 6 months; Part 2: between 2 and 15 pain crises in the past 12 months
  • Cohort B: fully active or able to carry out light activity only (performance status of 0 or 1)
  • Cohort B: blood counts within set ranges, including haemoglobin, neutrophils, platelets and reticulocytes

Who may not be able to

  • Cohort A: any significant medical condition that could affect the study results or put the person at risk
  • Cohort A: major surgery or planned surgery (except gut surgery) within 12 weeks of the first dose
  • Cohort B: any illness, infection or blood test problem that would make taking part too risky
  • Cohort B Part 1: more than 6 severe pain crises needing at least 24 hours in hospital in the past 12 months, or any episode of acute chest syndrome in the last 6 months
  • Cohort B: kidney clearance (creatinine clearance) below 60 mL/min/1.72m2
  • Both groups: regular red blood cell or platelet transfusions, or a recent red blood cell transfusion (within 28 days) or platelet transfusion (within 14 days) before starting treatment

What taking part involves

  • • Taking the study medicine BMS-986470 — how it is given and the dose are not stated, ask the trial team

Time commitment: Number of visits, how long the study lasts and what taking part involves are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
224
Started
2024-07-17
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for anemia, sickle cell
  • • Phase1/Phase2 - 224 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with anemia, sickle cell

Where?

  • • East Sussex - University Hospitals Sussex NHS Foundation Trust
  • • London - Local Institution - 0044
  • • London - King's College Hospital
  • • Leeds - Local Institution - 0005
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About 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.

Anemia, Sickle CellHealthy Volunteers

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ the following laboratory values:

What the study is looking for

  • ✓Cohort A:
  • ✓Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/\[height (m)\]2 as measured at screening.
  • ✓Cohort B:
  • ✓Participants with a documented diagnosis of sickle cell disease (SCD) with genotype HbSS, HbSβ0-thal, or HbSβ+-thal.
  • ✓Participant has an activity scale (ECOG) performance status of 0 or 1.

Who cannot take part

  • ✗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...
  • ✗Any major surgery or planned surgery (except GI surgery) within 12 weeks of the first study intervention administration.
  • ✗Cohort B:
See the full criteria
Inclusion 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 amenorrhoeic for at least 12 months without an alternative medical cause and have follicle-stimulating hormone (FSH) levels of at least 40 IU/L or have undergone a hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. * 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. Cohort B: * 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 within the previous 12 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. iv) Absolute reticulocyte count \> 100 × 10\^3/μL or \> 50 × 10\^3/μL if taking hydroxyurea. Exclusion Criteria: 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 participating in this study. * 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.

Where Is This Study? (5 UK sites)

University Hospitals Sussex NHS Foundation Trust

East Sussex BN2 1ES, United Kingdom

Recruiting
Site contact (verified)
Tom Rider, Site 000401276667758

Local Institution - 0044

London SE19RT, United Kingdom

NOT_YET_RECRUITING

King's College Hospital

London SE5 9RL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Local Institution - 0005

Leeds LS9 7TF, United Kingdom

NOT_YET_RECRUITING

Local Institution - 0047

London W12 0HS, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-08