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New pill could help patients with rare blood disorder

NCT ID NCT05002777

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental drug called rilzabrutinib in 22 adults with warm autoimmune hemolytic anemia (wAIHA), a condition where the immune system attacks red blood cells. Participants take the drug daily for up to 24 weeks, with an option to continue longer. The main goal is to see if it raises hemoglobin levels and reduces the need for blood transfusions or rescue medications.

What this could mean

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

Active substance
rilzabrutinib (a drug taken as a tablet by mouth)
What this could lead to
If it works, this could offer a new oral treatment option for people with warm autoimmune hemolytic anemia who have not responded well to steroids.
What could go wrong
This is a small, early-phase (Phase 2) study with only 22 participants, so results may not apply to everyone. The drug may not work as hoped or could have side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

22 people

The number who actually took part.

Started

Dec 2021

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 patients with a confirmed diagnosis of primary wAIHA or systemic lupus erythematosus (SLE)-associated wAIHA (without other SLE-related manifestations apart from cutaneous and musculoskeletal manifestations) * Participants who have previously failed to maintain a sustained response after treatment with corticosteroids. * Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower. * Up-to-date vaccination status as per local guidelines. * Body mass index (BMI) \>17.5 and \<40 kg/m2 * All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Core Part B * Evidence of treatment efficacy to rilzabrutinib as defined by achieving overall response during Part A. * Completion of Part A treatment period (24 weeks). Extended Part B * Completion of Core Part B period. Exclusion Criteria: * 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. * Secondary wAIHA from any cause including drugs, 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. * Myelodysplastic syndrome. * Uncontrolled or active HBV infection: Patients with positive HBsAg and/or HBV DNA. * HIV infection. * Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 half-lives, whichever is greater, prior to treatment start. * Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. Part B only * Participants who receive any therapy during Part A known to be active in wAIHA. * Presence of unacceptable side effect(s) or toxicity associated with rilzabrutinib such that there is an unfavorable risk-benefit assessment for continued treatment with rilzabrutinib in the opinion of the Investigator and/or Sponsor. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia, warm type

As listed by the trial registrant

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

Warm autoimmune hemolytic anemia (waiha)

Contacts and locations

Locations

  • Barts Health NHS Trust_Investigational Site Number: 8260005

    London, E1 2ES, United Kingdom

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz_Investigational Site Number: 3480001

    Székesfehérvár, 8000, Hungary

  • Georgetown University Hospital_Investigational Site Number: 8400003

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

  • Hanush-Krankenhaus_Investigational Site Number: 0400001

    Vienna, 1140, Austria

  • Hospital Clinic de Barcelona_Investigational Site Number: 7240001

    Barcelona, 08036, Spain

  • Hospital Universitario La Paz_Investigational Site Number: 7240003

    Madrid, 28046, Spain

  • Hospital Universitario Virgen del Rocío_Investigational Site Number: 7240002

    Seville, 41013, Spain

  • Hospital Universitario de Cruces_Investigational Site Number: 7240004

    Barakaldo, 48093, Spain

  • Imperial College Healthcare NHS Trust_Investigational Site Number: 8260002

    London, W2 1NY, United Kingdom

  • Institute of hematology&blood diseases hospital_Investigational Site Number: 1560003

    Tianjin, 300020, China

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"_Investigational Site Number: 3800003

    Meldola, 47014, Italy

  • Klinik für Hämatologie und Stammzellentransplantation_Investigational Site Number: 2760001

    Essen, 45147, Germany

  • Leeds Teaching Hospitals NHS Trust_Investigational Site Number: 8260001

    Leeds, LS9 7TF, United Kingdom

  • Massachusetts General Hospital_Investigational Site Number: 8400001

    Boston, Massachusetts, 02114, United States

  • Odense Universitetshospital Hæmatologisk Forskningsenhed_Investigational Site Number: 2080001

    Odense, 5000, Denmark

  • Oncology & Hematology Associates of West Broward_Investigational Site Number: 8400002

    Tamarac, Florida, 33321, United States

  • Ospedale Giuseppe Moscati_Investigational Site Number: 3800002

    Avellino, 83100, Italy

  • Ospedale Maggiore Policlinico_Investigational Site Number: 3800001

    Milan, 20149, Italy

  • Peking Union Medical College Hospital_Investigational Site Number: 1560002

    Beijing, 100005, China

  • TOI Clinical Research LLC_ Cerritos_Investigational Site Number: 8400006

    Cerritos, California, 90703, United States

  • TOI Clinical Research LLC_ Whittier_Investigational Site Number: 8400006

    Whittier, California, 90602, United States

  • TOI Clinical Research LLC_Glendale_Investigational Site Number: 8400006

    Glendale, California, 91204, United States

  • TOI Clinical Research LLC_Long Beach_Investigational Site Number: 8400006

    Long Beach, California, 90805, United States

  • TOI Clinical Research LLC_Santa Ana_Investigational Site Number: 8400006

    Santa Ana, California, 92705, United States

  • The Lundquist Institute_Investigational Site Number: 8400005

    Torrance, California, 90502, United States

  • The Oncology Institute of Hope & Innovation Site Number : 8400006

    Cerritos, California, 90703, United States

  • University of Southern California_Investigational Site Number: 8400009

    Los Angeles, California, 90033, United States

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