Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
22actual
Sites
27
Countries
Austria, China, Denmark +6
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| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-12-07 | actual | When the study began enrolling |
| Primary completion | 2024-05-23 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2021-08-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Warm Autoimmune Hemolytic Anemia (wAIHA)
Intervention
- Drug: rilzabrutinib — also filed as PRN1008/SAR444671
Primary outcomes
what the primary-completion date above is the date OFPart A: Proportion of participants with overall hemoglobin response
measured By Week 24 in Part A
Part B: Proportion of participants who maintain durable response achieved during Part A or achieve a durable response during Part B and have a hemoglobin response
measured By Week 50 in Part B
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