BMS-986470 for Sickle cell disease

Inclusion criteria

• {"criterion_text":"- Participants must be at least 18 years of age or older with a documented diagnosis of SCD with genotype HbSS, HbSβ0 -thal, or HbSβ+ -thal; ≥ 4 VOCs within the previous 12 months or ≥ 2 VOCs within the previous 6 months"}
• {"criterion_text":"- Participant has failed, is unable to tolerate, or is not a candidate for approved therapies for SCD therapies"}
• {"criterion_text":"- Participants must have the following laboratory values: Hb ≥ 5.5 and ≤ 12 g/dL (males) or ≥ 5.5 and ≤ 10.6 g/dL (females), absolute neutrophil ≥ 1500/μL , Platelet ≥ 100 × 103 /μL, absolute reticulocyte > 100 × 103 /μL or > 50 × 103 /μL if taking hydroxyurea."}

Exclusion criteria

• {"criterion_text":"- 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 drug or any VOC requiring ≥ 24 hours of hospital admission within 30 days prior to the first dose of study drug."}
• {"criterion_text":"- Participants with any episode of acute chest syndrome within the last 6 months prior to the first dose."}
• {"criterion_text":"- 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 participanting in this study."}

Primary endpoints

• {"endpoint_text":"- Incidence of adverse events (AEs), serious adverse events (SAEs), AEs meeting protocol-defined dose limiting toxicity (DLT) criteria, AEs leading to discontinuation, and death.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- A summary of the exposure levels of the study drug as well as changes in levels of different types of hemoglobin including fetal and sickle forms of hemoglobin.","definition_or_measurement_approach":""}
• {"endpoint_text":"- The study will also check whether other markers connected to sickle cell disease are improving","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

14-03-2025

Latest Decision Or Authorization Date

05-05-2026

Processing Time Days

417

Number Of Sites

5

Number Of Participants

6

Primary sponsor

Full Name

Bristol-Myers Squibb Services Unlimited Company

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Contract research organisations

Name

Iqvia Inc.

Responsibilities

Site Payments

Name

Labcorp

Responsibilities

HPLC Hemoglobin and EPO ICMA

Name

Labcorp Central Laboratory Services LP

Responsibilities

Speciality Biomarker Testing Lab

Name

QPS LLC

Responsibilities

PK analysis

Name

Clario

Responsibilities

Triplicate ECG collection and reading

Third parties

• {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance: Medical review & Cases Data Entry","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp","duties_or_roles":"HPLC Hemoglobin and EPO ICMA","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Site Payments","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clario","duties_or_roles":"Triplicate ECG collection and reading","organisation_type":"Health care"}
• {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Subject number assignment, treatment/arm assignment, drug (re) supplies assignment","organisation_type":"Non-Pharmaceutical company"}
• {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample storage for RNA, Serum, Whole Blood samples","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"submission administrative support","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Speciality Biomarker Testing Lab","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}