A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia
Recruiting · Phase 3 · NCT07086976
Conditions: Autoimmune Haemolytic Anaemia
At a glance
- Research payments reported, 2025
- $403,870
- U.S. investigators named
- 14
- Sites paid
- 14
- Planned or actual enrollment
- 90
About the trial
- Sponsor
- Sanofi
- Tested
- rilzabrutinib (drug), placebo (drug)
- Dates
- Started 2025-08-18; completion 2029-12-26
- Results posted
- Not yet
This is a parallel-group, Phase 3, double-blind, 2-arm study to investigate the efficacy, safety, PK and PD of oral rilzabrutinib in achieving durable Hb response (DHR) compared with placebo in approximately 90 male and female participants ≥ 18 years of age with a confirmed diagnosis of primary wAIHA. Following a 4-week screening period, eligible participants will be randomized in a 2:1 ratio to receive rilzabrutinib or placebo in primary analysis period (PAP) for a duration of up to 24 weeks. All participants who completed PAP will then continue in open-label period (OLP) to receive rilzabrutinib for a duration of 28 weeks. Upon the completion of OLP, only participants who demonstrate Hb…
From ClinicalTrials.gov, last updated 2026-10-20. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Genzyme Corporation reported $403,870 in research payments for this study in 2025 (19 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
- Suresh B. Katakkar, M.D. Hematology & Oncology · Tucson, AZ
- Surbhi Shah, M.D. Hematology & Oncology · Scottsdale, AZ
- Vinod Pullarkat, M.D. Hematology · Duarte, CA
- Sarah E. Tomassetti, M.D. Hematology & Oncology · Torrance, CA
- Luis G. Rangel, MD Hematology & Oncology · Hialeah, FL
- Sumit Sawhney, M.D. Hematology & Oncology · Coral Springs, FL
- Usha S. Perepu, MBBS Hematology & Oncology · Iowa City, IA
- Asra Z. Ahmed, MD Hematology · Ann Arbor, MI
- Ronald S. Go, MD Hematology · Rochester, MN
- James D'olimpio Hematology & Oncology · Lake Success, NY
- Zhengrui Xiao, MD Hematology & Oncology · Bronx, NY
- Marina Beltrami Moreira, MD, PHD Hematology · Columbus, OH
- Sandeep K. Rajan, M.D. Hematology & Oncology · Nashville, TN
- Reggie M. Thomes, D.O. Hematology & Oncology · La Crosse, WI
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Biomedical Research Alliance of New York Llc $54,673
- University of Michigan Health System, MI $46,530
- Mayo Clinic Mayo School of Cpd $35,290
- The Ohio State University $31,371
- City of Hope National Medical Ctr $30,300
- Mayo Clinic Hospital, AZ $28,145
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical C $26,025
- University of Texas Health San Antonio Department of Anesthesiology $23,604
- Gundersen Lutheran Medical Center $22,527
- Clinical Research Alliance Inc $22,338
- Bioresearch PArtner Holdings Lllp $19,250
- Baptist Clinical Research Institute $18,361
- Noble Clinical Research $17,900
- Advanced Research LLC $13,838
- $13,718
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.