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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07086976

Registry updated: 2026-10-20
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Description

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.

Interventions

  • rilzabrutinib (Drug)
    Pharmaceutical form:tablet-Route of administration:oral
  • placebo (Drug)
    Pharmaceutical form:tablet-Route of administration:oral

Eligibility criteria

Inclusion Criteria: * Male and female participants with a documented (confirmed) diagnosis of primary wAIHA for at least 6 months. * Participants who have previously failed to maintain a sustained response after treatment with CS (CS-resistance \[defined as failure to obtain hemoglobin response within 3 weeks on at least 1 mg/kg or 60 mg prednisone or equivalent per day\], CS-dependent wAIHA \[defined as need to continue on prednisone or equivalent at a dose of \>10 mg/day to maintain a response\]), or are intolerant or ineligible to CS (defined as with contraindications, pre-existing medical conditions or CS-related complications that may render CS intolerant or ineligible per the best clinical judgement of the investigators). * 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. Exclusion Criteria: * Participants with clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant or compromise the quality of the data derived from his or her participation in the study as determined by the Investigator. * Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years. * Participants with symptomatic herpes zoster within 3 months prior to screening. * Participants with mixed wAIHA, or secondary wAIHA from any cause including drugs, Evans Syndrome, lymphoproliferative disorders (low count monoclonal B-cell lymphocytosis is allowed), infectious or autoimmune disease, or active hematologic malignancies. Participants with positive antinuclear antibodies but without a definitive diagnosis of an autoimmune disease are allowed. * Participants with history of myelodysplastic syndrome. * Participants with uncontrolled or active HBV infection or Active HCV infection. * HIV infection. * Participants with history of solid organ transplant. * Participants with a history of active or latent tuberculosis (TB). * Splenectomy within 12 weeks before screening and planned surgery during the PAP. * Concurrent treatment with other experimental/investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to treatment start. Participants who previously received treatment with BTK inhibitors for wAIHA before Day 1 (randomization) are not eligible. * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Conditions

Autoimmune Haemolytic Anaemia

Locations

  • Mayo Clinic in Arizona - Phoenix- Site Number : 8400032 — Phoenix, Arizona, United States
  • Noble Clinical Research- Site Number : 8400003 — Tucson, Arizona, United States
  • City of Hope Comprehensive Cancer Center- Site Number : 8400023 — Duarte, California, United States
  • Cancer and Blood Specialty Clinic - Los Alamitos- Site Number : 8400038 — Los Alamitos, California, United States
  • USC Norris Comprehensive Cancer Center- Site Number : 8400007 — Los Angeles, California, United States
  • Stanford University Medical Center- Site Number : 8400026 — Stanford, California, United States
  • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center- Site Number : 8400006 — Torrance, California, United States
  • Yale University School of Medicine- Site Number : 8400027 — New Haven, Connecticut, United States
  • MedStar Georgetown University Hospital- Site Number : 8400004 — Washington D.C., District of Columbia, United States
  • Hialeah Hospital- Site Number : 8400009 — Hialeah, Florida, United States
  • Sylvester Comprehensive Cancer Center- Site Number : 8400031 — Miami, Florida, United States
  • University Hospital and Medical Center- Site Number : 8400005 — Tamarac, Florida, United States
  • Tulane University School of Medicine- Site Number : 8400037 — New Orleans, Louisiana, United States
  • Massachusetts General Hospital- Site Number : 8400001 — Boston, Massachusetts, United States
  • Beth Israel Deaconess Medical Center - Boston- Site Number : 8400034 — Boston, Massachusetts, United States
  • University of Michigan Health System - Ann Arbor- Site Number : 8400014 — Ann Arbor, Michigan, United States
  • Henry Ford Hospital- Site Number : 8400012 — Detroit, Michigan, United States
  • Mayo Clinic in Rochester - Minnesota- Site Number : 8400008 — Rochester, Minnesota, United States
  • Montefiore Medical Center - Einstein Campus- Site Number : 8400011 — The Bronx, New York, United States
  • Cleveland Clinic - Cleveland- Site Number : 8400029 — Cleveland, Ohio, United States
  • Ohio State University Hospital East- Site Number : 8400020 — Columbus, Ohio, United States
  • Fox Chase Cancer Center - Philadelphia- Site Number : 8400019 — Philadelphia, Pennsylvania, United States
  • Brown University Health - Rhode Island Hospital- Site Number : 8400028 — Providence, Rhode Island, United States
  • Baptist Memorial Hospital- Site Number : 8400018 — Memphis, Tennessee, United States
  • UT Health - San Antonio- Site Number : 8400015 — San Antonio, Texas, United States
  • Fred Hutchinson Cancer Center- Site Number : 8400016 — Seattle, Washington, United States
  • Gundersen Health System - La Crosse Medical Center- Site Number : 8400033 — La Crosse, Wisconsin, United States
  • Investigational Site Number : 0320001 — Rosario, Santa Fe Province, Argentina
  • Investigational Site Number : 0320003 — Buenos Aires, Argentina
  • Investigational Site Number : 0320002 — Buenos Aires, Argentina
  • Investigational Site Number : 0400001 — Vienna, Austria
  • Investigational Site Number : 0400002 — Vienna, Austria
  • Hemoes - Centro Estadual de Hemoterapia e Hematologia Marcos Daniel Santos- Site Number : 0760002 — Vitória, Espírito Santo, Brazil
  • Universidade Federal de Goias- Site Number : 0760001 — Goiânia, Goiás, Brazil
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760003 — São Paulo, Brazil
  • Investigational Site Number : 1560001 — Beijing, China
  • Investigational Site Number : 1560007 — Chengde, China
  • Investigational Site Number : 1560011 — Guangzhou, China
  • Investigational Site Number : 1560005 — Guangzhou, China
  • Investigational Site Number : 1560009 — Hohhot, China
  • Investigational Site Number : 1560003 — Nanchang, China
  • Investigational Site Number : 1560012 — Nanchang, China
  • Investigational Site Number : 1560004 — Suzhou, China
  • Investigational Site Number : 1560002 — Tianjin, China
  • Investigational Site Number : 1560010 — Wuhan, China
  • Investigational Site Number : 1560006 — Xi'an, China
  • Investigational Site Number : 1560008 — Zhengzhou, China
  • Investigational Site Number : 2030001 — Brno, Czechia
  • Investigational Site Number : 2030002 — Prague, Czechia
  • Investigational Site Number : 2080003 — Aarhus, Denmark
  • Investigational Site Number : 2080002 — Copenhagen, Denmark
  • Investigational Site Number : 2080001 — Odense, Denmark
  • Investigational Site Number : 2760003 — Berlin, Germany
  • Investigational Site Number : 2760001 — Essen, Germany
  • Investigational Site Number : 2760004 — Frankfurt, Germany
  • Investigational Site Number : 2760006 — Leipzig, Germany
  • Investigational Site Number : 3000002 — Athens, Greece
  • Investigational Site Number : 3000001 — Exochi, Greece
  • Investigational Site Number : 3000005 — Larissa, Greece
  • Investigational Site Number : 3000004 — Pátrai, Greece
  • Investigational Site Number : 3000003 — Pátrai, Greece
  • Investigational Site Number : 3480004 — Budapest, Hungary
  • Investigational Site Number : 3480002 — Debrecen, Hungary
  • Investigational Site Number : 3760001 — Afula, Israel
  • Investigational Site Number : 3760007 — Haifa, Israel
  • Investigational Site Number : 3760005 — Kefar Sava, Israel
  • Investigational Site Number : 3760008 — Safed, Israel
  • Investigational Site Number : 3760002 — Tel Aviv, Israel
  • Investigational Site Number : 3800004 — Florence, Firenze, Italy
  • Investigational Site Number : 3800010 — Genoa, Genova, Italy
  • Investigational Site Number : 3800001 — Milan, Milano, Italy
  • Investigational Site Number : 3800005 — Naples, Napoli, Italy
  • Investigational Site Number : 3800002 — Meldola, Reggio Emilia, Italy
  • Investigational Site Number : 3800009 — Novara, Italy
  • Investigational Site Number : 3800006 — Palermo, Italy
  • Investigational Site Number : 3800007 — Trieste, Italy
  • Investigational Site Number : 3800008 — Varese, Italy
  • Investigational Site Number : 3800003 — Vicenza, Italy
  • Investigational Site Number : 3920007 — Nagoya, Aichi-ken, Japan
  • Investigational Site Number : 3920013 — Tsuchiura, Ibaraki, Japan
  • Investigational Site Number : 3920006 — Kanazawa, Ishikawa-ken, Japan
  • Investigational Site Number : 3920012 — Fujisawa, Kanagawa, Japan
  • Investigational Site Number : 3920003 — Suita, Osaka, Japan
  • Investigational Site Number : 3920001 — Iruma, Saitama, Japan
  • Investigational Site Number : 3920010 — Kofu, Yamanashi, Japan
  • Investigational Site Number : 3920015 — Fukuoka, Japan
  • Investigational Site Number : 3920002 — Fukushima, Japan
  • Investigational Site Number : 3920014 — Kyoto, Japan
  • Investigational Site Number : 3920008 — Okayama, Japan
  • Investigational Site Number : 3920004 — Tokushima, Japan
  • Investigational Site Number : 3920005 — Yamagata, Japan
  • Investigational Site Number : 5280002 — Amsterdam, Netherlands
  • Investigational Site Number : 5280003 — Leiden, Netherlands
  • Investigational Site Number : 6160005 — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
  • Investigational Site Number : 6160006 — Lodz, Lódzkie, Poland
  • Investigational Site Number : 6820004 — Jeddah, Saudi Arabia
  • Investigational Site Number : 6820003 — Riyadh, Saudi Arabia
  • Investigational Site Number : 7240003 — Seville, Andalusia, Spain
  • Investigational Site Number : 7240005 — Bizkaia, Basque Country, Spain
  • Investigational Site Number : 7240001 — Barcelona, Catalunya [Cataluña], Spain
  • Investigational Site Number : 7240007 — Majadahonda, Madrid, Spain
  • Investigational Site Number : 7240004 — Madrid, Spain
  • Investigational Site Number : 7520004 — Gothenburg, Sweden
  • Investigational Site Number : 7520001 — Huddinge, Sweden
  • Investigational Site Number : 7520003 — Malmö, Sweden
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record