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New drug rilzabrutinib aims to tame rare blood disorder

NCT ID NCT07086976

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study tests an oral drug called rilzabrutinib for warm autoimmune hemolytic anemia (wAIHA), a condition where the immune system attacks red blood cells. About 90 adults who have not responded well to steroids will receive either rilzabrutinib or a placebo for 24 weeks, followed by an open-label period where everyone gets the drug. The goal is to see if rilzabrutinib can safely raise hemoglobin levels and reduce the need for other treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rilzabrutinib
What this could lead to
If successful, this could offer a new oral treatment option for people with warm autoimmune hemolytic anemia, potentially reducing the need for steroids and blood transfusions.
What could go wrong
This is an early Phase 3 trial with only 90 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and female participants with a documented (confirmed) diagnosis of primary wAIHA for at least 6 months. * Participants who have previously failed to maintain a sustained response after treatment with CS (CS-resistance \[defined as failure to obtain hemoglobin response within 3 weeks on at least 1 mg/kg or 60 mg prednisone or equivalent per day\], CS-dependent wAIHA \[defined as need to continue on prednisone or equivalent at a dose of \>10 mg/day to maintain a response\]), or are intolerant or ineligible to CS (defined as with contraindications, pre-existing medical conditions or CS-related complications that may render CS intolerant or ineligible per the best clinical judgement of the investigators). * Participants with Eastern Cooperative Oncology Group (ECOG) performance status Grade 2 or lower. * Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * Participants with clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant or compromise the quality of the data derived from his or her participation in the study as determined by the Investigator. * Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years. * Participants with symptomatic herpes zoster within 3 months prior to screening. * Participants with mixed wAIHA, or secondary wAIHA from any cause including drugs, Evans Syndrome, lymphoproliferative disorders (low count monoclonal B-cell lymphocytosis is allowed), infectious or autoimmune disease, or active hematologic malignancies. Participants with positive antinuclear antibodies but without a definitive diagnosis of an autoimmune disease are allowed. * Participants with history of myelodysplastic syndrome. * Participants with uncontrolled or active HBV infection or Active HCV infection. * HIV infection. * Participants with history of solid organ transplant. * Participants with a history of active or latent tuberculosis (TB). * Splenectomy within 12 weeks before screening and planned surgery during the PAP. * Concurrent treatment with other experimental/investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to treatment start. Participants who previously received treatment with BTK inhibitors for wAIHA before Day 1 (randomization) are not eligible. * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia autoimmune hemolytic anemia, warm type

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune haemolytic anaemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    95 sites in 17 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Baptist Memorial Hospital- Site Number : 8400018

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • Brown University Health - Rhode Island Hospital- Site Number : 8400028

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • City of Hope National Medical Center- Site Number : 8400023

    RECRUITING

    Duarte, California, 91010, United States

  • Fox Chase Cancer Center - Philadelphia- Site Number : 8400019

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Center- Site Number : 8400016

    RECRUITING

    Seattle, Washington, 98109, United States

  • Gundersen Health System - La Crosse Medical Center- Site Number : 8400033

    RECRUITING

    La Crosse, Wisconsin, 54601, United States

  • Hemoes - Centro Estadual de Hemoterapia e Hematologia Marcos Daniel Santos- Site Number : 0760002

    RECRUITING

    Vitória, Espírito Santo, 29047-105, Brazil

  • Henry Ford Hospital- Site Number : 8400012

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hialeah Hospital- Site Number : 8400009

    RECRUITING

    Hialeah, Florida, 33013, United States

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760003

    RECRUITING

    São Paulo, 05403-000, Brazil

  • Investigational Site Number : 0320001

    RECRUITING

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320002

    RECRUITING

    Buenos Aires, 1431, Argentina

  • Investigational Site Number : 0320003

    RECRUITING

    Buenos Aires, 1181, Argentina

  • Investigational Site Number : 0400001

    RECRUITING

    Vienna, 1090, Austria

  • Investigational Site Number : 0400002

    RECRUITING

    Vienna, 1140, Austria

  • Investigational Site Number : 1560001

    RECRUITING

    Beijing, 100730, China

  • Investigational Site Number : 1560002

    RECRUITING

    Tianjin, 300020, China

  • Investigational Site Number : 1560003

    RECRUITING

    Nanchang, 330006, China

  • Investigational Site Number : 1560004

    RECRUITING

    Suzhou, 215006, China

  • Investigational Site Number : 1560005

    RECRUITING

    Guangzhou, 510180, China

  • Investigational Site Number : 1560006

    RECRUITING

    Xi'an, 710054, China

  • Investigational Site Number : 1560007

    RECRUITING

    Chengde, 067020, China

  • Investigational Site Number : 1560008

    RECRUITING

    Zhengzhou, 450008, China

  • Investigational Site Number : 1560009

    RECRUITING

    Hohhot, 010050, China

  • Investigational Site Number : 1560010

    RECRUITING

    Wuhan, 430022, China

  • Investigational Site Number : 1560011

    RECRUITING

    Guangzhou, 510000, China

  • Investigational Site Number : 1560012

    RECRUITING

    Nanchang, 330006, China

  • Investigational Site Number : 2030001

    RECRUITING

    Brno, 625 00, Czechia

  • Investigational Site Number : 2030002

    RECRUITING

    Prague, Cardiff [Caerdydd Gb-crd], 128 20, Czechia

  • Investigational Site Number : 2080001

    RECRUITING

    Odense, 5000, Denmark

  • Investigational Site Number : 2080002

    RECRUITING

    Copenhagen, 2100, Denmark

  • Investigational Site Number : 2080003

    RECRUITING

    Aarhus, 8200, Denmark

  • Investigational Site Number : 2760001

    RECRUITING

    Essen, 45147, Germany

  • Investigational Site Number : 2760003

    RECRUITING

    Berlin, 10707, Germany

  • Investigational Site Number : 3000001

    RECRUITING

    Thessaloniki, 570 10, Greece

  • Investigational Site Number : 3000002

    RECRUITING

    Athens, 115 27, Greece

  • Investigational Site Number : 3000003

    RECRUITING

    Pátrai, 265 04, Greece

  • Investigational Site Number : 3000004

    RECRUITING

    Pátrai, 254 43, Greece

  • Investigational Site Number : 3000005

    RECRUITING

    Larissa, 411 10, Greece

  • Investigational Site Number : 3480002

    RECRUITING

    Debrecen, 4032, Hungary

  • Investigational Site Number : 3480004

    RECRUITING

    Budapest, 1085, Hungary

  • Investigational Site Number : 3760001

    RECRUITING

    Afula, 1834111, Israel

  • Investigational Site Number : 3760002

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Investigational Site Number : 3760005

    RECRUITING

    Kefar Sava, 4428164, Israel

  • Investigational Site Number : 3760007

    RECRUITING

    Haifa, 3104802, Israel

  • Investigational Site Number : 3800001

    RECRUITING

    Milan, Milano, 20122, Italy

  • Investigational Site Number : 3800002

    RECRUITING

    Meldola, Reggio Emilia, 47014, Italy

  • Investigational Site Number : 3800003

    RECRUITING

    Vicenza, 36100, Italy

  • Investigational Site Number : 3800004

    RECRUITING

    Florence, Firenze, 50134, Italy

  • Investigational Site Number : 3800005

    RECRUITING

    Naples, Napoli, 80131, Italy

  • Investigational Site Number : 3800006

    RECRUITING

    Palermo, 90146, Italy

  • Investigational Site Number : 3800007

    RECRUITING

    Trieste, 34125, Italy

  • Investigational Site Number : 3800008

    RECRUITING

    Varese, 21100, Italy

  • Investigational Site Number : 3800009

    RECRUITING

    Novara, 28100, Italy

  • Investigational Site Number : 3800010

    RECRUITING

    Genoa, Genova, 16132, Italy

  • Investigational Site Number : 3920001

    RECRUITING

    Iruma, Saitama, 350-0495, Japan

  • Investigational Site Number : 3920002

    RECRUITING

    Fukushima, 960-1295, Japan

  • Investigational Site Number : 3920003

    RECRUITING

    Suita, Osaka, 565-0871, Japan

  • Investigational Site Number : 3920004

    RECRUITING

    Tokushima, 770-8503, Japan

  • Investigational Site Number : 3920005

    RECRUITING

    Yamagata, 990-9585, Japan

  • Investigational Site Number : 3920006

    RECRUITING

    Kanazawa, Ishikawa-ken, 920-8201, Japan

  • Investigational Site Number : 3920007

    RECRUITING

    Nagoya, Aichi-ken, 453-8511, Japan

  • Investigational Site Number : 3920008

    RECRUITING

    Okayama, 700-8557, Japan

  • Investigational Site Number : 3920010

    RECRUITING

    Kofu, Yamanashi, 400-0027, Japan

  • Investigational Site Number : 3920012

    RECRUITING

    Fujisawa, Kanagawa, 251-0052, Japan

  • Investigational Site Number : 3920013

    RECRUITING

    Tsuchiura, Ibaraki, 300-0028, Japan

  • Investigational Site Number : 3920014

    RECRUITING

    Kyoto, 605-0981, Japan

  • Investigational Site Number : 3920015

    RECRUITING

    Fukuoka, 815-8555, Japan

  • Investigational Site Number : 5280002

    RECRUITING

    Amsterdam, 1081 HV, Netherlands

  • Investigational Site Number : 5280003

    RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Investigational Site Number : 6160005

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-090, Poland

  • Investigational Site Number : 6160006

    RECRUITING

    Lodz, Lódzkie, 90-302, Poland

  • Investigational Site Number : 7240001

    RECRUITING

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Investigational Site Number : 7240003

    RECRUITING

    Seville, Sevilla, 41013, Spain

  • Investigational Site Number : 7240004

    RECRUITING

    Madrid, 28007, Spain

  • Investigational Site Number : 7240005

    RECRUITING

    Barakaldo, Basque Country, 48903, Spain

  • Investigational Site Number : 7240007

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Investigational Site Number : 7520001

    RECRUITING

    Huddinge, 141 57, Sweden

  • Investigational Site Number : 7520003

    RECRUITING

    Malmö, 205 02, Sweden

  • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center- Site Number : 8400006

    RECRUITING

    Torrance, California, 90502, United States

  • Massachusetts General Hospital- Site Number : 8400001

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic in Arizona - Phoenix- Site Number : 8400032

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Rochester - Minnesota- Site Number : 8400008

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MedStar Georgetown University Hospital- Site Number : 8400004

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Montefiore Medical Center - Einstein Campus- Site Number : 8400011

    RECRUITING

    The Bronx, New York, 10461, United States

  • Noble Clinical Research- Site Number : 8400003

    RECRUITING

    Tucson, Arizona, 85704, United States

  • Ohio State University Hospital East- Site Number : 8400020

    RECRUITING

    Columbus, Ohio, 43203, United States

  • Stanford University Medical Center- Site Number : 8400026

    RECRUITING

    Stanford, California, 94305, United States

  • Sylvester Comprehensive Cancer Center- Site Number : 8400031

    RECRUITING

    Miami, Florida, 33136, United States

  • USC Norris Comprehensive Cancer Center- Site Number : 8400007

    RECRUITING

    Los Angeles, California, 90033, United States

  • UT Health - San Antonio- Site Number : 8400015

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Universidade Federal de Goias- Site Number : 0760001

    RECRUITING

    Goiânia, Goiás, 74605-020, Brazil

  • University Hospital and Medical Center- Site Number : 8400005

    RECRUITING

    Tamarac, Florida, 33321, United States

  • University of Michigan Health System - Ann Arbor- Site Number : 8400014

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Yale University School of Medicine- Site Number : 8400027

    RECRUITING

    New Haven, Connecticut, 06510, United States

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