A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia

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NCT07086976 · readout in 651 d

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

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

90estimated

Sites

Countries

Argentina, Austria, Brazil +14

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

2025-08-18

actual

When the study began enrolling

Primary completion

2028-05-31

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2029-12-26

estimated

The whole study's end, after follow-up

First posted

2025-07-25

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-06-04

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Autoimmune Haemolytic Anaemia

Interventions

Drug: rilzabrutinib — also filed as SAR444671
Drug: placebo

Primary outcome

what the primary-completion date above is the date OF

Proportion of participants achieving DHR. DHR is defined as an increase of Hb by ≥2 g/dL from baseline on at least two thirds of evaluable scheduled visits between Week 12 and Week 24 (inclusive) in the PAP

measured By Week 24

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