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Tests treatment safety and results for Sickle Cell Disease
Official title The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease
ClinicalTrials.gov ID: NCT06975865
What this study is testing
What is Rilzabrutinib?
Rilzabrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for sickle cell disease.
Also referred to as SAR444671.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 65
You may be able to join if
- Participants who have been diagnosed with SCD.
- Participants who have had between ≥2 and ≤10 episodes of documented clinical VOC within 12 months of the screening events.
- 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...
- 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...
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply: Participants with medical history of lymphoma, leukemia, or any...
- 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)
See the full eligibility criteria
- Participants who have been diagnosed with SCD.
- Participants who have had between ≥2 and ≤10 episodes of documented clinical VOC within 12 months of the screening events.
- 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 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Fresno, California, United States
- Coral Springs, Florida, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Flowood, Mississippi, United States
- Staten Island, New York, United States
- The Bronx, New York, United States
- Greenville, South Carolina, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
- Brussels, Belgium
- Leuven, Belgium
- Salvador, Estado de Bahia, Brazil
- Goiânia, Goiás, Brazil
+ 27 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Fresno, California, United States; Coral Springs, Florida, United States; Miami, Florida, United States; Chicago, Illinois, United States and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.