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
Public ClinicalTrials.gov record NCT07086976. 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 Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Period and Long-term Extension to Assess the Efficacy and Safety of Rilzabrutinib in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)
Study identification
- NCT ID
- NCT07086976
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Sanofi
- Industry
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Interventions
- placebo Drug
- rilzabrutinib Drug
Drug
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
- Aug 17, 2025
- Primary completion
- May 30, 2028
- Completion
- Dec 25, 2029
- Last update posted
- Apr 30, 2026
2025 – 2029
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Arizona - Phoenix- Site Number : 8400032 | Phoenix | Arizona | 85054 | Recruiting |
| Noble Clinical Research- Site Number : 8400003 | Tucson | Arizona | 85704 | Recruiting |
| City of Hope National Medical Center- Site Number : 8400023 | Duarte | California | 91010 | Recruiting |
| USC Norris Comprehensive Cancer Center- Site Number : 8400007 | Los Angeles | California | 90033 | Recruiting |
| Stanford University Medical Center- Site Number : 8400026 | Stanford | California | 94305 | Recruiting |
| Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center- Site Number : 8400006 | Torrance | California | 90502 | Recruiting |
| Yale University School of Medicine- Site Number : 8400027 | New Haven | Connecticut | 06510 | Recruiting |
| Hialeah Hospital- Site Number : 8400009 | Hialeah | Florida | 33013 | Recruiting |
| Sylvester Comprehensive Cancer Center- Site Number : 8400031 | Miami | Florida | 33136 | Recruiting |
| University Hospital and Medical Center- Site Number : 8400005 | Tamarac | Florida | 33321 | Recruiting |
| University of Michigan Health System - Ann Arbor- Site Number : 8400014 | Ann Arbor | Michigan | 48109 | Recruiting |
| Henry Ford Hospital- Site Number : 8400012 | Detroit | Michigan | 48202 | Recruiting |
| Mayo Clinic in Rochester - Minnesota- Site Number : 8400008 | Rochester | Minnesota | 55905 | Recruiting |
| Montefiore Medical Center - Einstein Campus- Site Number : 8400011 | The Bronx | New York | 10461 | Recruiting |
| Ohio State University Hospital East- Site Number : 8400020 | Columbus | Ohio | 43203 | Recruiting |
| Fox Chase Cancer Center - Philadelphia- Site Number : 8400019 | Philadelphia | Pennsylvania | 19111 | Recruiting |
| Brown University Health - Rhode Island Hospital- Site Number : 8400028 | Providence | Rhode Island | 02903 | Recruiting |
| Baptist Memorial Hospital- Site Number : 8400018 | Memphis | Tennessee | 38120 | Recruiting |
| UT Health - San Antonio- Site Number : 8400015 | San Antonio | Texas | 78229 | Recruiting |
| Fred Hutchinson Cancer Center- Site Number : 8400016 | Seattle | Washington | 98109 | Recruiting |
| Gundersen Health System - La Crosse Medical Center- Site Number : 8400033 | La Crosse | Wisconsin | 54601 | Recruiting |
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 71 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07086976, 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 Apr 30, 2026 · Synced May 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07086976 live on ClinicalTrials.gov.