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NCT07086976 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Autoimmune Haemolytic Anaemia, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT07086976: Recruiting Phase 3 study of Autoimmune Haemolytic Anaemia, sponsored by Sanofi.
NCT07086976 is a Phase 3 study of Autoimmune Haemolytic Anaemia that is actively recruiting participants, run by Sanofi. The registered enrollment target is 90 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07086976, a Phase 3 study of Autoimmune Haemolytic Anaemia, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
DHR is defined as an increase of Hb by ≥2 g/dL from baseline on at least two thirds of evaluable scheduled visits between Week 12 and Week 24 (inclusive) in the PAP in the absence of rescue medication and transfusion.
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 |
What NCT07086976 shows while recruiting
NCT07086976 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
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.
NCT07086976 names 20 study sites across 14 states, led by California, Florida, Arizona.
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.
What interventions are being tested in trial NCT07086976?
The interventions under investigation include: placebo (DRUG), rilzabrutinib (DRUG).
Who is sponsoring clinical trial NCT07086976?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07086976's enrollment target sits among peer trials
90 1725th of 2000 higher than 263 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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