Last updated 6 days ago
The Efficacy and Safety of Rilzabrutinib in Patients Aged 10 to 65 Years With Sickle-cell Disease
192 patients around the world
Available in United States, Brazil
Sanofi
5Research sites
192Patients around the world
This study is for people with
Rare diseases
Sickle cell disease
Requirements for the patient
To 65 Years
All Gender
Medical requirements
- Participants who have been diagnosed with SCD.Participants who have had between ≥2 to ≤10 episodes of documented acute clinical VOC within 12 months of the screening visit.Participants who are either not on hydroxyurea and/or L-glutamine at the Screening Visit and does not plan to receive them during the course of the study or has received HU and/or L-glutamine for a minimum of 6 months.Participants on hydroxyurea and/or L-glutamine must have been on a stable weight-based dose level (mg/kg) for at least 3 months prior to the Screening Visit, with the intent to continue at the same weight-based dose level for the duration of the study, except for safety reasons.Participants with Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower.Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.For participants ≥10 to <18 years of age: the parent(s)/legal guardian(s) must provide written informed consent prior to any study-related procedures being performed.
- Participants are excluded from the study if any of the following criteria apply: Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years.Clinically relevant cardiac abnormality, in the opinion of the Investigator or electrocardiogram (ECG) findings.Participants with history of stroke, or history of abnormal transcranial doppler.Participants with uncontrolled or active HBV infection and/or HCV infection including those receiving antiviral therapy at the time of screening.HIV infection.A history of active or latent tuberculosis (TB).Positive COVID-19 molecular test.Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days and/or voxelotor (OXBRYTA®) within 30 days prior to the Screening visit.
Sites
Hospital Samaritano de São Paulo
Recruiting
Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia
Recruiting
Universidade Federal da Bahia
Recruiting
Hospital das Clínicas da Universidade Federal de Goiás - UFG
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
StudyLIBRA
SponsorSanofi
Study typeInterventional
Conditions
Sickle cell disease
Requirements
To 65 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06975865
