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

PHASE3RecruitingINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

August 12, 2025

Primary Completion Date

July 23, 2027

Study Completion Date

December 29, 2028

Conditions
Sickle Cell Disease
Interventions
DRUG

Rilzabrutinib

Pharmaceutical form:Tablet -Route of administration:Oral

DRUG

Placebo

Pharmaceutical form:Tablet -Route of administration:Oral

Trial Locations (22)

1020

RECRUITING

Investigational Site Number : 0560003, Brussels

1070

RECRUITING

Investigational Site Number : 0560002, Brussels

10314

RECRUITING

Richmond University Medical Center- Site Number : 8400038, Staten Island

11527

RECRUITING

Investigational Site Number : 3000003, Athens

18101

RECRUITING

Investigational Site Number : 3760002, Afula

20122

RECRUITING

Investigational Site Number : 3800004, Milan

28007

RECRUITING

Investigational Site Number : 7240002, Madrid / Madrid

28046

RECRUITING

Investigational Site Number : 7240001, Madrid

33013

ACTIVE_NOT_RECRUITING

Bioresearch Partners- Site Number : 8400005, Hialeah

33200

RECRUITING

Investigational Site Number : 7920003, Mersin

94000

RECRUITING

Investigational Site Number : 2500002, Créteil

3109601

RECRUITING

Investigational Site Number : 3760005, Haifa

RECRUITING

Investigational Site Number : 3760006, Haifa

40050-410

RECRUITING

Hospital Santa Izabel / Santa Casa de Misericordia da Bahia- Site Number : 0760006, Salvador

40210-720

RECRUITING

Universidade Federal da Bahia - Site Number : 0760009, Salvador

74605-020

RECRUITING

EBSERH Hospital das Clínicas da Universidade Federal de Goiás- Site Number : 0760002, Goiânia

15090-000

RECRUITING

Fund. Faculdade Reg de Medicina de SJRP- Site Number : 0760001, São José do Rio Preto

01232-010

RECRUITING

Hospital Samaritano- Site Number : 0760005, São Paulo

01130

RECRUITING

Investigational Site Number : 7920001, Adana

01330

RECRUITING

Investigational Site Number : 7920002, Balcali Adana

NW10 7NS

RECRUITING

Investigational Site Number : 8260002, London

SE5 9PJ

RECRUITING

Investigational Site Number : 8260001, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT06975865 - The Efficacy and Safety of Rilzabrutinib in Patients Aged 10 to 65 Years With Sickle-cell Disease | Biotech Hunter | Biotech Hunter