Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)
Public ClinicalTrials.gov record NCT05002777. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05002777
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 22 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 6, 2021
- Primary completion
- May 22, 2024
- Completion
- Dec 30, 2029
- Last update posted
- Jun 4, 2026
2021 – 2029
United States locations
- U.S. sites
- 11
- U.S. states
- 4
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Oncology Institute of Hope & Innovation Site Number : 8400006 | Cerritos | California | 90703 | — |
| TOI Clinical Research LLC_ Cerritos_Investigational Site Number: 8400006 | Cerritos | California | 90703 | — |
| TOI Clinical Research LLC_Glendale_Investigational Site Number: 8400006 | Glendale | California | 91204 | — |
| TOI Clinical Research LLC_Long Beach_Investigational Site Number: 8400006 | Long Beach | California | 90805 | — |
| University of Southern California_Investigational Site Number: 8400009 | Los Angeles | California | 90033 | — |
| TOI Clinical Research LLC_Santa Ana_Investigational Site Number: 8400006 | Santa Ana | California | 92705 | — |
| The Lundquist Institute_Investigational Site Number: 8400005 | Torrance | California | 90502 | — |
| TOI Clinical Research LLC_ Whittier_Investigational Site Number: 8400006 | Whittier | California | 90602 | — |
| Georgetown University Hospital_Investigational Site Number: 8400003 | Washington D.C. | District of Columbia | 20007 | — |
| Oncology & Hematology Associates of West Broward_Investigational Site Number: 8400002 | Tamarac | Florida | 33321 | — |
| Massachusetts General Hospital_Investigational Site Number: 8400001 | Boston | Massachusetts | 02114 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05002777, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2026 · Synced Sep 16, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05002777 live on ClinicalTrials.gov.