Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New pill aims to cut sickle cell pain attacks in half

NCT ID NCT06975865

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether the oral drug rilzabrutinib can lower the number of painful vaso-occlusive crises in people with sickle cell disease. About 192 participants aged 10 to 65 will receive either the drug or a placebo for 52 weeks. The main goal is to see if the drug reduces crisis rates compared to placebo.

What this could mean

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

Active substance
rilzabrutinib (an oral tablet)
What this could lead to
If it works, this could provide a new daily pill to reduce painful sickle cell crises and related complications.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The drug may not reduce crises more than placebo, and side effects are possible.

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 192 people

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

Started

Aug 2025

Expected to finish

Dec 2028

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

10 to 65 years

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: * Participants who have been diagnosed with SCD. * Participants who have had between ≥2 and ≤10 episodes of documented clinical VOC within 12 months of the screening events. * Participants who are either not on hydroxyurea and/or L-glutamine at the Screening Visit and does not plan to receive them during the course of the study or has received HU and/or L-glutamine for a minimum of 6 months. Participants on hydroxyurea and/or L-glutamine must have been on a stable weight-based dose level (mg/kg) for at least 3 months prior to the Screening Visit, with the intent to continue at the same weight-based dose level for the duration of the study, except for safety reasons. * 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. * For participants ≥10 to \<18 years of age: the parent(s)/legal guardian(s) must provide written informed consent prior to any study-related procedures being performed. Exclusion Criteria: * Participants are excluded from the study if any of the following criteria apply: 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. * Clinically relevant cardiac abnormality, in the opinion of the Investigator or electrocardiogram (ECG) findings. * Participants with history of stroke, or history of abnormal transcranial doppler. * Participants with uncontrolled or active HBV infection and/or HCV infection including those receiving antiviral therapy at the time of screening. * HIV infection. * A history of active or latent tuberculosis (TB) * Positive COVID-19 molecular test. * Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days and/or voxelotor (OXBRYTA®) within 30 days prior to the Screening visit. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Sickle cell disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

sickle cell disease

As listed by the trial registrant

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

Sickle cell disease

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

    53 sites in 13 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

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello-Site Number : 3800002

    RECRUITING

    Palermo, 90146, Italy

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga, SSD Microcitemie Malattie Rare Ematologiche-Site Number : 3800007

    RECRUITING

    Orbassano, Torino, 10043, Italy

  • Azienda Ospedaliera Universitaria, Università della Campania "Luigi Vanvitelli" Napoli-Site Number : 3800005

    RECRUITING

    Naples, Napoli, 80138, Italy

  • Azienda Ospedaliero Universitaria Careggi SOD Ematologia-Site Number : 3800006

    RECRUITING

    Florence, Firenze, 50134, Italy

  • Baylor College of Medicine- Site Number : 8400055

    RECRUITING

    Houston, Texas, 77030, United States

  • Centro Ricerche Cliniche Verona s.r.l. presso Ospedale G.B. Rossi Borgo Roma-Site Number : 3800003

    RECRUITING

    Verona, 37134, Italy

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760001

    RECRUITING

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Hospital Samaritano De Sao Paulo- Site Number : 0760005

    RECRUITING

    São Paulo, 01232-010, Brazil

  • Hospital Santa Izabel- Site Number : 0760006

    RECRUITING

    Salvador, Estado de Bahia, 40050-410, Brazil

  • IRCCS Ospedale Pediatrico Bambino Gesù-Site Number : 3800001

    RECRUITING

    Rome, Roma, 00165, Italy

  • Indiana University Health Riley Hospital for Children- Site Number : 8400056

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Investigational Site Number : 0560001

    RECRUITING

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    RECRUITING

    Brussels, 1070, Belgium

  • Investigational Site Number : 0560003

    RECRUITING

    Brussels, 1020, Belgium

  • Investigational Site Number : 2500001

    RECRUITING

    Paris, 75015, France

  • Investigational Site Number : 2500002

    RECRUITING

    Créteil, 94010, France

  • Investigational Site Number : 2500004

    RECRUITING

    Toulouse, 31100, France

  • Investigational Site Number : 2500005

    RECRUITING

    Marseille, 13885, France

  • Investigational Site Number : 2760002

    RECRUITING

    Essen, 45147, Germany

  • Investigational Site Number : 2760004

    RECRUITING

    Stuttgart, 70736, Germany

  • Investigational Site Number : 3000001

    RECRUITING

    Athens, 115 27, Greece

  • Investigational Site Number : 3000002

    RECRUITING

    Pátrai, 265 04, Greece

  • Investigational Site Number : 3000003

    RECRUITING

    Athens, 115 27, Greece

  • Investigational Site Number : 3760001

    RECRUITING

    Afula, 1834111, Israel

  • Investigational Site Number : 3760002

    RECRUITING

    Afula, 1834111, Israel

  • Investigational Site Number : 3760005

    RECRUITING

    Haifa, 3109601, Israel

  • Investigational Site Number : 3760006

    RECRUITING

    Haifa, 3109601, Israel

  • Investigational Site Number : 3800004

    RECRUITING

    Milan, Milano, 20122, Italy

  • Investigational Site Number : 5120001

    RECRUITING

    Muscat, 123, Oman

  • Investigational Site Number : 5280002

    RECRUITING

    Rotterdam, 3015 CE, Netherlands

  • Investigational Site Number : 7240001

    RECRUITING

    Madrid, 28046, Spain

  • Investigational Site Number : 7240002

    RECRUITING

    Madrid, 28007, Spain

  • Investigational Site Number : 7920001

    RECRUITING

    Adana, 01330, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    RECRUITING

    Adana, 01330, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    RECRUITING

    Mersin, 33330, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    RECRUITING

    London, London, City of, SE5 9RL, United Kingdom

  • Investigational Site Number : 8260002

    RECRUITING

    London, Harrow, NW10 7NS, United Kingdom

  • Louisiana State University Health Sciences Center - Shreveport- Site Number : 8400037

    RECRUITING

    Shreveport, Louisiana, 71130, United States

  • Montefiore Medical Center - Moses Campus- Site Number : 8400057

    RECRUITING

    The Bronx, New York, 10467, United States

  • Oncology & Hematology Associates of West Broward- Site Number : 8400029

    RECRUITING

    Coral Springs, Florida, 33065, United States

  • Phoenix Children's Hospital- Site Number : 8400028

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Pontifícia Universidade Católica do Rio de Janeiro- Site Number : 0760009

    RECRUITING

    Rio de Janeiro, 22451-900, Brazil

  • Prisma Health- Site Number : 8400051

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Richmond University Medical Center- Site Number : 8400038

    RECRUITING

    Staten Island, New York, 10310, United States

  • Southern Specialty Research- Site Number : 8400059

    RECRUITING

    Flowood, Mississippi, 39232, United States

  • Sylvester Comprehensive Cancer Center- Site Number : 8400020

    RECRUITING

    Miami, Florida, 33136, United States

  • Universidade Federal de Goias- Site Number : 0760002

    RECRUITING

    Goiânia, Goiás, 74605-020, Brazil

  • University of Alabama at Birmingham- Site Number : 8400003

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of California San Francisco- Site Number : 8400040

    RECRUITING

    Fresno, California, 93701, United States

  • University of Illinois-Chicago - College of Medicine- Site Number : 8400054

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Maryland School of Medicine - Baltimore- Site Number : 8400041

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Michigan Health System - Ann Arbor- Site Number : 8400035

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • VCU Massey Cancer Center: Dalton Oncology Clinic- Site Number : 8400012

    RECRUITING

    Richmond, Virginia, 23298, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.