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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07086976

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.

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ClinicalTrials.gov public records Last synced Sep 12, 2026, 5:32 PM EDT

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a parallel-group, Phase 3, double-blind, 2-arm study to investigate the efficacy, safety, PK and PD of oral rilzabrutinib in achieving durable Hb response (DHR) compared with placebo in approximately 90 male and female participants ≥ 18 years of age with a confirmed diagnosis of primary wAIHA. Following a 4-week screening period, eligible participants will be randomized in a 2:1 ratio to receive rilzabrutinib or placebo in primary analysis period (PAP) for a duration of up to 24 weeks. All participants who completed PAP will then continue in open-label period (OLP) to receive rilzabrutinib for a duration of 28 weeks. Upon the completion of OLP, only participants who demonstrate Hb increase during the last 8 weeks of OLP per specified criteria in the protocol will be eligible to continue in long-term extension (LTE) of the study. The duration of the LTE period will be from the first-participant-in (FPI)-LTE until the last participant completes 52 weeks in LTE. The safety follow-up period of this study following treatment completion or discontinuation will be 2 weeks.

Study identification

NCT ID
NCT07086976
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
90 participants

Conditions and interventions

Interventions

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
Aug 20, 2026

2025 – 2029

United States locations

U.S. sites
23
U.S. states
16
U.S. cities
23
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
MedStar Georgetown University Hospital- Site Number : 8400004 Washington D.C. District of Columbia 20007 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
Massachusetts General Hospital- Site Number : 8400001 Boston Massachusetts 02114 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 72 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 Aug 20, 2026 · Synced Sep 12, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07086976 live on ClinicalTrials.gov.

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