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NCT05002777 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)
A Phase 2 study of Warm Autoimmune Hemolytic Anemia (wAIHA), sponsored by Sanofi.
- Active
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 20
- Study locations
NCT05002777 is a Phase 2 study of Warm Autoimmune Hemolytic Anemia (wAIHA) that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 22 participants. The trial reports 20 study locations across 5 states.
The verdict
NCT05002777, a Phase 2 study of Warm Autoimmune Hemolytic Anemia (wAIHA), is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. 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 713 total studies on file at ClinicalTrials.gov.
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.
NCT05002777 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Other, California, District of Columbia.
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).
What interventions are being tested in trial NCT05002777?
The interventions under investigation include: rilzabrutinib (DRUG).
Who is sponsoring clinical trial NCT05002777?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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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