🏛️ Verified NIH Record • Updated 2026-06-03

Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) (NCT05002777)

A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (LUMINA 2)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Sanofi

🩺 Plain-English Summary (8th-Grade Level)

All participants will receive rilzabrutinib orally. The screening period is up to 28 days, followed by a treatment period of 24 weeks for Part A. Participants who complete Part A and are deemed eligible for Part B can continue in the Core Part B period followed by an Extended Part B period for up to 253 weeks. There will be a 7-day safety follow-up period after receiving the last dose of study medication either in Part A (for those not eligible for Part B or early terminated) or Part B. In addition, each participant will be asked to attend an EOT-Core Part B visit when the last participant completes 52 weeks in Core Part B. The Extended Part B period will last for up to 253 weeks. The study is currently in the Part B Extension segment.

Who can join: Review the eligibility criteria below.

Location: The Oncology Institute of Hope & Innovation Site Number : 8400006 — Cerritos, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (27 Sites)

Showing the first 25 of 27 sites.

  • The Oncology Institute of Hope & Innovation Site Number : 8400006 — Cerritos, California
  • TOI Clinical Research LLC_ Cerritos_Investigational Site Number: 8400006 — Cerritos, California
  • TOI Clinical Research LLC_Glendale_Investigational Site Number: 8400006 — Glendale, California
  • TOI Clinical Research LLC_Long Beach_Investigational Site Number: 8400006 — Long Beach, California
  • University of Southern California_Investigational Site Number: 8400009 — Los Angeles, California
  • TOI Clinical Research LLC_Santa Ana_Investigational Site Number: 8400006 — Santa Ana, California
  • The Lundquist Institute_Investigational Site Number: 8400005 — Torrance, California
  • TOI Clinical Research LLC_ Whittier_Investigational Site Number: 8400006 — Whittier, California
  • Georgetown University Hospital_Investigational Site Number: 8400003 — Washington D.C., District of Columbia
  • Oncology & Hematology Associates of West Broward_Investigational Site Number: 8400002 — Tamarac, Florida
  • Massachusetts General Hospital_Investigational Site Number: 8400001 — Boston, Massachusetts
  • Hanush-Krankenhaus_Investigational Site Number: 0400001 — Vienna,
  • Peking Union Medical College Hospital_Investigational Site Number: 1560002 — Beijing,
  • Institute of hematology&blood diseases hospital_Investigational Site Number: 1560003 — Tianjin,
  • Odense Universitetshospital Hæmatologisk Forskningsenhed_Investigational Site Number: 2080001 — Odense,
  • Klinik für Hämatologie und Stammzellentransplantation_Investigational Site Number: 2760001 — Essen,
  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz_Investigational Site Number: 3480001 — Székesfehérvár,
  • Ospedale Giuseppe Moscati_Investigational Site Number: 3800002 — Avellino,
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"_Investigational Site Number: 3800003 — Meldola,
  • Ospedale Maggiore Policlinico_Investigational Site Number: 3800001 — Milan,
  • Hospital Universitario de Cruces_Investigational Site Number: 7240004 — Barakaldo,
  • Hospital Clinic de Barcelona_Investigational Site Number: 7240001 — Barcelona,
  • Hospital Universitario La Paz_Investigational Site Number: 7240003 — Madrid,
  • Hospital Universitario Virgen del Rocío_Investigational Site Number: 7240002 — Seville,
  • Leeds Teaching Hospitals NHS Trust_Investigational Site Number: 8260001 — Leeds,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Warm Autoimmune Hemolytic Anemia (wAIHA)

Explore by condition: All Warm Autoimmune Hemolytic Anemia (wAIHA) clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗