Status:
RECRUITING
The Efficacy and Safety of Rilzabrutinib in Patients Aged 10 to 65 Years With Sickle-cell Disease
Lead Sponsor:
Sanofi
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
10-65 years
Phase:
PHASE3
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential study (Part A), followed by an open-label LTE period (Part B) to investigate the efficacy, and saf...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
August 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2028
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06975865
Start Date
August 12 2025
End Date
December 29 2028
Last Update
December 19 2025
Active Locations (42)
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1
University of Alabama at Birmingham- Site Number : 8400003
Birmingham, Alabama, United States, 35233
2
Oncology & Hematology Associates of West Broward- Site Number : 8400029
Coral Springs, Florida, United States, 33065
3
Indiana University School of Medicine - Riley Hospital for Children- Site Number : 8400056
Indianapolis, Indiana, United States, 46202
4
Louisiana State University Health Sciences Center - Shreveport- Site Number : 8400037
Shreveport, Louisiana, United States, 71130