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

PHASE3RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

August 18, 2025

Primary Completion Date

May 31, 2028

Study Completion Date

December 26, 2029

Conditions
Autoimmune Haemolytic Anaemia
Interventions
DRUG

rilzabrutinib

Pharmaceutical form:tablet-Route of administration:oral

DRUG

placebo

Pharmaceutical form:tablet-Route of administration:oral

Trial Locations (30)

1090

RECRUITING

Investigational Site Number : 0400001, Vienna

1140

RECRUITING

Investigational Site Number : 0400002, Vienna

2100

RECRUITING

Investigational Site Number : 2080002, Copenhagen

5000

RECRUITING

Investigational Site Number : 2080001, Odense C

8200

RECRUITING

Investigational Site Number : 2080003, Aarhus N

10707

RECRUITING

Investigational Site Number : 2760003, Charlottenburg

14186

RECRUITING

Investigational Site Number : 7520001, Stockholm

20122

RECRUITING

Investigational Site Number : 3800001, Milan

21428

RECRUITING

Investigational Site Number : 7520003, Malmo

26443

RECRUITING

Investigational Site Number : 3000004, Pátrai

28100

RECRUITING

Investigational Site Number : 3800009, Novara

41013

RECRUITING

Investigational Site Number : 7240003, Seville

50134

RECRUITING

Investigational Site Number : 3800004, Florence

57010

RECRUITING

Investigational Site Number : 3000001, Thessaloniki

64239

RECRUITING

Investigational Site Number : 3760002, Tel Aviv

100730

RECRUITING

Investigational Site Number : 1560001, Beijing

330006

RECRUITING

Investigational Site Number : 1560003, Nanchang

510180

RECRUITING

Investigational Site Number : 1560005, Guangzhou

S2000DEJ

RECRUITING

Investigational Site Number : 0320001, Rosario

74605-020

RECRUITING

HC UFG - Hospital Das Clinicas de Goias- Site Number : 0760001, Goiânia

05403-000

RECRUITING

Hospital das Clinicas de Sao Paulo- Site Number : 0760003, São Paulo

128 00

RECRUITING

Investigational Site Number : 2030002, Prague

265 04

RECRUITING

Investigational Site Number : 3000003, Pátrai

960-1295

RECRUITING

Investigational Site Number : 3920002, Fukushima

920-8201

RECRUITING

Investigational Site Number : 3920006, Kanazawa

251-8550

RECRUITING

Investigational Site Number : 3920012, Fujisawa-shi

565-0871

RECRUITING

Investigational Site Number : 3920003, Suita

350-0495

RECRUITING

Investigational Site Number : 3920001, Iruma-gun

1081 HV

RECRUITING

Investigational Site Number : 5280002, Amsterdam

08036

RECRUITING

Investigational Site Number : 7240001, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY