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A Phase 1/2a, First-in-human Study to Evaluate BMS-986470 in Healthy Volunteers and Participants with Sickle Cell Disease
EU CTIS ID: 2023-510283-12-00
What this study is testing
To check if BMS-986470 is safe and well-tolerated when given alone to healthy participants and participants with sickle cell disease. To find out the recommended phase 2 dose (RP2D) of BMS-986470 in participants with sickle cell disease.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Participant has failed, is unable to tolerate, or is not a candidate for approved therapies for SCD therapies
- 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.
You likely can't join if
- 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.
- Participants with any episode of acute chest syndrome within the last 6 months prior to the first dose.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.