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Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)
NCT05002777 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG rilzabrutinib
Study Locations (20)
Other
- 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
California
- The Oncology Institute of Hope & Innovation Site Number : 8400006 — Cerritos
- TOI Clinical Research LLC_ Cerritos_Investigational Site Number: 8400006 — Cerritos
- TOI Clinical Research LLC_Glendale_Investigational Site Number: 8400006 — Glendale
- TOI Clinical Research LLC_Long Beach_Investigational Site Number: 8400006 — Long Beach
- University of Southern California_Investigational Site Number: 8400009 — Los Angeles
- TOI Clinical Research LLC_Santa Ana_Investigational Site Number: 8400006 — Santa Ana
- The Lundquist Institute_Investigational Site Number: 8400005 — Torrance
- TOI Clinical Research LLC_ Whittier_Investigational Site Number: 8400006 — Whittier
District of Columbia
- Georgetown University Hospital_Investigational Site Number: 8400003 — Washington D.C.
Florida
- Oncology & Hematology Associates of West Broward_Investigational Site Number: 8400002 — Tamarac
Massachusetts
- Massachusetts General Hospital_Investigational Site Number: 8400001 — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-12-07 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05002777
The ClinicalTrials.gov registry entry for NCT05002777 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Warm Autoimmune Hemolytic Anemia (wAIHA) appearing as the primary indexed condition, and to 1 intervention — of which rilzabrutinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05002777 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05002777 about?
NCT05002777 is a clinical study titled "Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)". 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...
What is the current status of trial NCT05002777?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2021-12-07. Estimated completion is 2029-12-31.
What conditions does trial NCT05002777 study?
This clinical trial studies the following conditions: Warm Autoimmune Hemolytic Anemia (wAIHA). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05002777?
The interventions under investigation include: rilzabrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05002777?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05002777 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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