Clinical Trial
Study Details
Pharmaceutical form:Tablet -Route of administration:Oral
Pharmaceutical form:Tablet -Route of administration:Oral
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-adaptive, group-sequential study (Part A), followed by an open-label LTE period (Part B) to investigate the efficacy, and safety of rilzabrutinib in participants with sickle-cell disease (SCD).
Study details include:
* Study duration: a 52-week double-blind period (Part A), followed by an open-label LTE period (Part B). Double-blind period has two parts, 50% (adult only) until the interim analysis (a proof-concept part analogous to a phase 2b study), and 50% (adult and children) after the interim analysis. Only the participants who complete double-blind treatment period (Part A) are eligible to continue to the LTE period. The duration of the LTE period (Part B) will be from the first-participant-in (FPI)-LTE (Part B) until the last participant who enters the LTE has completed 52 weeks.
* Treatment duration: 52-week double-blind period (Part A); LTE period (Part B) from the (FPI until the last participant who enters the LTE has completed 52 weeks.
* Visit frequency: Week visits based on the Schedule of Assessments.
Study Overview
Contacts and Locations
University of Alabama at Birmingham- Site Number : 8400003
Birmingham, Alabama 35233
United States
Phoenix Children's Hospital- Site Number : 8400028
Phoenix, Arizona 85016
United States
University of California San Francisco- Site Number : 8400040
Clovis, California 93611
United States
David Geffen School of Medicine at UCLA- Site Number : 8400032
Los Angeles, California 90095
United States
MedStar Georgetown University Hospital- Site Number : 8400036
Washington D.C., District of Columbia 20007
United States
Oncology & Hematology Associates of West Broward- Site Number : 8400029
Coral Springs, Florida 33065
United States
Sylvester Comprehensive Cancer Center- Site Number : 8400020
Miami, Florida 33136
United States
University of Illinois-Chicago - College of Medicine- Site Number : 8400054
Chicago, Illinois 60612
United States
Indiana University Health Riley Hospital for Children- Site Number : 8400056
Indianapolis, Indiana 46202
United States
Louisiana State University Health Sciences Center - Shreveport- Site Number : 8400037
Shreveport, Louisiana 71130
United States
University of Maryland School of Medicine - Baltimore- Site Number : 8400041
Baltimore, Maryland 21201
United States
University of Michigan Health System - Ann Arbor- Site Number : 8400035
Ann Arbor, Michigan 48109
United States
Southern Specialty Research- Site Number : 8400059
Flowood, Mississippi 39232
United States
Richmond University Medical Center- Site Number : 8400038
Staten Island, New York 10310
United States
Montefiore Medical Center - Moses Campus- Site Number : 8400057
The Bronx, New York 10467
United States
Oregon Health & Science University (OHSU)- Site Number : 8400043
Portland, Oregon 97239
United States
Prisma Health- Site Number : 8400051
Greenville, South Carolina 29605
United States
University of Tennessee Health Science Center- Site Number : 8400045
Memphis, Tennessee 38103
United States
Baylor College of Medicine- Site Number : 8400055
Houston, Texas 77030
United States
UT Physicians - Memorial Hermann- Site Number : 8400052
Houston, Texas 77030
United States
VCU Massey Cancer Center: Dalton Oncology Clinic- Site Number : 8400012
Richmond, Virginia 23298
United States
Investigational Site Number : 0560003
1020 Brussels
Belgium
Investigational Site Number : 0560002
1070 Brussels
Belgium
Investigational Site Number : 0560001
3000 Leuven
Belgium
Investigational Site Number : 0560004
4000 Liège
Belgium
Hospital Santa Izabel- Site Number : 0760006
Salvador-Estado de Bahia
40050-410
Brazil
Fundação Bahiana de Infectologia- Site Number : 0760009
Salvador-Estado de Bahia
40110-160
Brazil
Universidade Federal de Goias- Site Number : 0760002
Goiânia-Goiás
74605-020
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760001
São José do Rio Preto-São Paulo
15090-000
Brazil
Hospital Samaritano De Sao Paulo- Site Number : 0760005
São Paulo
01232-010
Brazil
Investigational Site Number : 2500002
94010 Créteil
France
Investigational Site Number : 2500005
13885 Marseille
France
Investigational Site Number : 2500001
75015 Paris
France
Investigational Site Number : 2500004
31100 Toulouse
France
Investigational Site Number : 2760005
13353 Berlin
Germany
Investigational Site Number : 2760002
45147 Essen
Germany
Investigational Site Number : 2760004
70736 Stuttgart
Germany
Investigational Site Number : 3000001
115 27 Athens
Greece
Investigational Site Number : 3000003
115 27 Athens
Greece
Investigational Site Number : 3000002
265 04 Pátrai
Greece
Investigational Site Number : 3760001
Afula 1834111
Israel
Investigational Site Number : 3760002
Afula 1834111
Israel
Investigational Site Number : 3760005
Haifa 3109601
Israel
Investigational Site Number : 3760006
Haifa 3109601
Israel
Investigational Site Number : 3800006
50134 Florence Firenze
Italy
Investigational Site Number : 3800008
16128 Genoa Genova
Italy
Investigational Site Number : 3800004
20122 Milan Milano
Italy
Investigational Site Number : 3800005
80138 Naples Napoli
Italy
Investigational Site Number : 3800001
00165 Rome Roma
Italy
Investigational Site Number : 3800007
10043 Orbassano Torino
Italy
Investigational Site Number : 3800002
90146 Palermo
Italy
Investigational Site Number : 3800003
37134 Verona
Italy
Investigational Site Number : 5280002
3015 CE Rotterdam
Netherlands
Investigational Site Number : 5120001
Muscat
Oman
Investigational Site Number : 6820003
Riyadh 12713
Saudi Arabia
Investigational Site Number : 7240001
28046 Madrid Madrid, Comunidad de
Spain
Investigational Site Number : 7240002
28007 Madrid
Spain
Investigational Site Number : 8260002
London
Harrow
NW10 7NS
United Kingdom
Investigational Site Number : 8260001
London
London, City of
SE5 9RL
United Kingdom
Investigational Site Number : 8260005
Manchester
M13 9WL
United Kingdom