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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
NCT07086976 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG placebo
- DRUG rilzabrutinib
Study Locations (20)
California
- City of Hope National Medical Center- Site Number : 8400023 — Duarte
- USC Norris Comprehensive Cancer Center- Site Number : 8400007 — Los Angeles
- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center- Site Number : 8400006 — Torrance
Florida
- Hialeah Hospital- Site Number : 8400009 — Hialeah
- Sylvester Comprehensive Cancer Center- Site Number : 8400031 — Miami
- University Hospital and Medical Center- Site Number : 8400005 — Tamarac
Arizona
- Mayo Clinic in Arizona - Phoenix- Site Number : 8400032 — Phoenix
- Noble Clinical Research- Site Number : 8400003 — Tucson
Michigan
- University of Michigan Health System - Ann Arbor- Site Number : 8400014 — Ann Arbor
- Henry Ford Hospital- Site Number : 8400012 — Detroit
Connecticut
- Yale University School of Medicine- Site Number : 8400027 — New Haven
Minnesota
- Mayo Clinic in Rochester - Minnesota- Site Number : 8400008 — Rochester
New York
- Montefiore Medical Center - Einstein Campus- Site Number : 8400011 — The Bronx
Ohio
- Ohio State University Hospital East- Site Number : 8400020 — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2025-08-18 |
| Est. Completion | 2029-12-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07086976
The ClinicalTrials.gov registry entry for NCT07086976 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 90 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 Autoimmune Haemolytic Anaemia appearing as the primary indexed condition, and to 2 interventions — of which placebo 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: NCT07086976 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Arizona. 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 NCT07086976 about?
NCT07086976 is a clinical study titled "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". 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 wAIH...
What is the current status of trial NCT07086976?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2025-08-18. Estimated completion is 2029-12-26.
What conditions does trial NCT07086976 study?
This clinical trial studies the following conditions: Autoimmune Haemolytic Anaemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07086976?
The interventions under investigation include: placebo (DRUG), rilzabrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07086976?
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 NCT07086976 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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