Condition: Autoimmune Haemolytic Anaemia · Sponsor: Sanofi
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 increase during the last 8 weeks of OLP per specified criteria in the protocol will be eligible to continue in long-term extension (LTE) of the study. The duration of the LTE period will be from the first-participant-in (FPI)-LTE until the last participant completes 52 weeks in LTE. The safety follow-up period of this study following treatment completion or discontinuation will be 2 weeks.
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.
| Mayo Clinic in Arizona - Phoenix- Site Number : 8400032 | Phoenix, Arizona, United States | Recruiting |
| Noble Clinical Research- Site Number : 8400003 | Tucson, Arizona, United States | Recruiting |
| City of Hope National Medical Center- Site Number : 8400023 | Duarte, California, United States | Recruiting |
| USC Norris Comprehensive Cancer Center- Site Number : 8400007 | Los Angeles, California, United States | Recruiting |
| Stanford University Medical Center- Site Number : 8400026 | Stanford, California, United States | Recruiting |
| Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center- Site Number : 8400006 | Torrance, California, United States | Recruiting |
| Yale University School of Medicine- Site Number : 8400027 | New Haven, Connecticut, United States | Recruiting |
| MedStar Georgetown University Hospital- Site Number : 8400004 | Washington D.C., District of Columbia, United States | Recruiting |
| Hialeah Hospital- Site Number : 8400009 | Hialeah, Florida, United States | Recruiting |
| Sylvester Comprehensive Cancer Center- Site Number : 8400031 | Miami, Florida, United States | Recruiting |
| University Hospital and Medical Center- Site Number : 8400005 | Tamarac, Florida, United States | Recruiting |
| Massachusetts General Hospital- Site Number : 8400001 | Boston, Massachusetts, United States | Recruiting |
+ 83 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07086976