The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease
Recruiting · Phase 3 · NCT06975865
Conditions: Sickle Cell Disease
At a glance
- Research payments reported, 2025
- $144,261
- U.S. investigators named
- 6
- Sites paid
- 6
- Planned or actual enrollment
- 192
About the trial
- Sponsor
- Sanofi
- Tested
- Rilzabrutinib (drug), Placebo (drug)
- Dates
- Started 2025-08-12; completion 2028-12-29
- Results posted
- Not yet
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 c…
From ClinicalTrials.gov, last updated 2026-10-15. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $144,261 in research payments for this study in 2025 (93 payments).
Products named: Wayrilz
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Luis G. Rangel, MD Hematology & Oncology · Hialeah, FL
- Sumit Sawhney, M.D. Hematology & Oncology · Coral Springs, FL
- Claire K. Willie, MD Internal Medicine · Riverdale, GA
- Poornima Ramadas, MD Hematology & Oncology · Shreveport, LA
- Omofolarin B. Fasuyi, M.D, M.P.H Family Medicine · Rolla, MO
- Victoria A. Forte, MD Hematology & Oncology · Brooklyn, NY
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Viva Capital Funding Llc $33,550
- Louisiana State University Health Sciences Center Shreveport School of Medicine $23,800
- Morehouse School of Medicine Inc $20,495
- Bioresearch PArtner Holdings Lllp $18,750
- Advanced Research LLC $17,754
- Richmond University Medical Center, NY $16,780
- $13,132
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.