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New hope for sickle cell patients: drug aims to cut painful crises

NCT ID NCT06439082

Disease control Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 5 times

Summary

This study tests a drug called crizanlizumab in people aged 12 and older with sickle cell disease who have frequent pain crises. The goal is to see if the drug can reduce the number of these crises compared to a placebo. Participants may also continue taking their usual treatments like hydroxyurea.

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 354 people

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

Started

Oct 2024

Expected to finish

Jul 2030

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

12 to 100 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.

Key Inclusion Criteria: 1. Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to \<18 years old and adults include participants aged 18 years and older. 2. Confirmed diagnosis of SCD by Hb electrophoresis or high-performance liquid chromatography (HPLC) (performed locally or by central laboratory if not available locally). All SCD genotypes are eligible. 3. Experienced 4 to 12 VOCs (refer to Section 8.3.1 for study definition of VOC) that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Baseline VOCs are determined by medical history and are required to be documented at source. 4. If the participant is on HU/HC, they must be taking it for at least 6 months and at stable dose for at least 3 months prior to the Screening visit and plan to continue taking it at the same dose and schedule until at least the participant has reached 52 weeks of the planned study treatment. Participants who have initiated HU/HC 6-12 months prior to the screening visit must have evidence of insufficient control of acute pain despite initiation. These participants must have a cumulative of 4-12 VOCs in the 12 months prior to the screening period, with at least 2 during the last 6 months while on HU/HC. If receiving erythropoietin stimulating agent, the participant must have been receiving the drug for at least 6 months prior to screening visit and plan to continue taking the drug at the same dose and schedule until the participant has reached 52 weeks of the planned study treatment. Participants who have not been receiving HU/HC, and/or erythropoietin stimulating agent must not have received it for at least 6 months prior to screening visit. Key Exclusion Criteria: 1. Fewer than 4 or more than 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to screening visit as determined by medical history and documented at source. 2. History of stem cell transplant and/or gene therapy. 3. Received blood products within 30 days prior to Week 1 Day 1 dosing. 4. Any documented history of a clinical stroke or intracranial hemorrhage, or an uninvestigated neurologic finding within the past 12 months before screening visit. Silent infarct only present on imaging is not excluded. 5. Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning to undergo an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted. 6. Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.

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Conditions

The condition(s) this trial relates to.

hematologic disorder sickle cell disease Sickle Cell Trait Vaso-Occlusive Crises

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 places running it

    35 sites in 5 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Augusta University Georgia

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Childrens Hospital at Montefiore

    RECRUITING

    The Bronx, New York, 10467, United States

  • Childrens National Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Ctr for Inherited Blood Disorders

    RECRUITING

    Orange, California, 92868, United States

  • East Carolina University

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Norton Children s Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Novartis Investigative Site

    RECRUITING

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Luís, Maranhão, 65020-070, Brazil

  • Novartis Investigative Site

    RECRUITING

    Campinas, São Paulo, 13083-970, Brazil

  • Novartis Investigative Site

    RECRUITING

    Ribeirão Preto, São Paulo, 14048-900, Brazil

  • Novartis Investigative Site

    RECRUITING

    Sao Jose Rio Preto, São Paulo, 15090-000, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 01232-010, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 08270-070, Brazil

  • Novartis Investigative Site

    RECRUITING

    Medellín, Antioquia, 050001, Colombia

  • Novartis Investigative Site

    RECRUITING

    Cali, Valle del Cauca Department, 760032, Colombia

  • Novartis Investigative Site

    RECRUITING

    Cali, Valle del Cauca Department, 760046, Colombia

  • Novartis Investigative Site

    RECRUITING

    Montería, 230001, Colombia

  • Novartis Investigative Site

    RECRUITING

    Ahero, Kisumu County, 40100, Kenya

  • Novartis Investigative Site

    RECRUITING

    Kisumu, 40100, Kenya

  • Novartis Investigative Site

    RECRUITING

    Kisumu, 40103, Kenya

  • Novartis Investigative Site

    RECRUITING

    Siaya, 40600, Kenya

  • Novartis Investigative Site

    RECRUITING

    Kampala, 101, Uganda

  • Novartis Investigative Site

    RECRUITING

    Masaka, 001, Uganda

  • Novartis Investigative Site

    RECRUITING

    Tororo, 10102, Uganda

  • Southern Specialty Research

    RECRUITING

    Flowood, Mississippi, 39232, United States

  • Spoknwrdclinicaltrials

    RECRUITING

    Easton, Pennsylvania, 18045, United States

  • Texas Childrens Cancer and Hematology Center

    RECRUITING

    Houston, Texas, 77030, United States

  • The Johns Hopkins University School of Medicine

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Thomas Jefferson University Me

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • U of TX Health Science Ct

    RECRUITING

    Houston, Texas, 77030, United States

  • Uni of Illinois Hospital and HSC

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University Of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Florida

    RECRUITING

    Jacksonville, Florida, 32209, United States

  • WCG Sonar Clinical Research

    RECRUITING

    Riverdale, Georgia, 30274, United States

  • Wake Forest University Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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