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The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease

← catalyst calendar

NCT06975865 · readout in 338 d

Sponsored by Sanofi (industry) · SNY — their whole pipeline →.

Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
192estimated
Sites
53
Countries
Belgium, Brazil, France +10

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2025-08-12actualWhen the study began enrolling
Primary completion2027-07-23estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2028-12-29estimatedThe whole study's end, after follow-up
First posted2025-05-16actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-29actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Sickle Cell Disease

Interventions

  • Drug: Rilzabrutinib — also filed as SAR444671
  • Drug: Placebo

Primary outcome

what the primary-completion date above is the date OF
Annualized rate of clinical VOC
measured At Week 52

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