Condition: Sickle Cell Disease · Sponsor: Sanofi
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.
This description comes directly from the study's public registry record.
Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com
Always discuss trial participation with your own doctor first.
| University of Alabama at Birmingham- Site Number : 8400003 | Birmingham, Alabama, United States | Recruiting |
| Phoenix Children's Hospital- Site Number : 8400028 | Phoenix, Arizona, United States | Recruiting |
| University of California San Francisco- Site Number : 8400040 | Fresno, California, United States | Recruiting |
| Oncology & Hematology Associates of West Broward- Site Number : 8400029 | Coral Springs, Florida, United States | Recruiting |
| Sylvester Comprehensive Cancer Center- Site Number : 8400020 | Miami, Florida, United States | Recruiting |
| University of Illinois-Chicago - College of Medicine- Site Number : 8400054 | Chicago, Illinois, United States | Recruiting |
| Indiana University Health Riley Hospital for Children- Site Number : 8400056 | Indianapolis, Indiana, United States | Recruiting |
| Louisiana State University Health Sciences Center - Shreveport- Site Number : 8400037 | Shreveport, Louisiana, United States | Recruiting |
| University of Maryland School of Medicine - Baltimore- Site Number : 8400041 | Baltimore, Maryland, United States | Recruiting |
| University of Michigan Health System - Ann Arbor- Site Number : 8400035 | Ann Arbor, Michigan, United States | Recruiting |
| Southern Specialty Research- Site Number : 8400059 | Flowood, Mississippi, United States | Recruiting |
| Richmond University Medical Center- Site Number : 8400038 | Staten Island, New York, United States | Recruiting |
+ 41 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06975865