Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

A Phase 4 Study of Crizanlizumab Treatment for Patients with Sickle Cell Disease Who Previously Participated in Novartis Clinical Trials

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Sickle Cell Disease, a condition where red blood cells become crescent-shaped and can block blood vessels, causing pain and other complications. The study will use crizanlizumab, which is given through an intravenous infusion (delivered directly into a vein). This medication is designed to help prevent blood cells from sticking together and forming blockages in blood vessels.

The purpose of this research is to continue providing crizanlizumab treatment to patients with Sickle Cell Disease who have previously participated in other studies of this medication. The treatment will be administered through an intravenous line every few weeks, with each dose calculated based on the patient's weight. The maximum dose will be 7.5 milligrams per kilogram of body weight.

During the study, which may last up to 120 months, patients will receive regular infusions of crizanlizumab. The medical team will monitor the patients' health and track any side effects that may occur during the treatment. This monitoring will help ensure patient safety throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive crizanlizumab (SEG101) through an intravenous infusion (medication given directly into a vein)

    The medication comes as a concentrate that will be prepared as a solution for your infusion

  2. Step 2

    Regular treatment visits

    Your participation requires regular visits for infusion treatments

    Each visit includes monitoring of your sickle cell disease condition

    Healthcare providers will track any side effects or reactions to the treatment

  3. Step 3

    Ongoing monitoring

    Healthcare providers will monitor the frequency and severity of any treatment-related effects

    Regular assessments will evaluate how your body responds to the medication

    The study continues until June 2031

  4. Step 4

    Safety assessments

    Throughout the study, your health status will be regularly evaluated

    Any changes in your condition or new symptoms will be documented

    The medical team will assess if any health changes are related to the treatment

  5. Step 5

    Study completion

    The study continues as long as you benefit from the treatment

    Regular evaluations will determine if continuing treatment remains appropriate for your condition

    The study is scheduled to end in June 2031

Who can join the trial?

8 criteria

  • Must be an adult patient able to provide written consent according to local guidelines
  • Must have sickle cell disease (SCD) - a condition where red blood cells become hard and form a crescent shape
  • Must be currently participating in and benefiting from a Novartis study where they receive crizanlizumab treatment
  • Must have completed all requirements of their current study
  • Must have shown good attendance at scheduled study visits
  • Must be willing and able to continue attending future scheduled visits
  • Can be either male or female
  • Must be at least 18 years old

Who cannot join the trial?

10 criteria

  • Patients who are not currently receiving crizanlizumab treatment in a Novartis-sponsored study
  • Patients who do not have a confirmed diagnosis of sickle cell disease (a genetic blood disorder that affects red blood cells)
  • Patients who are not able to provide informed consent
  • Pregnant or breastfeeding women
  • Patients with severe allergic reactions to crizanlizumab or any of its components
  • Patients with severe organ damage or dysfunction
  • Patients participating in other clinical trials
  • Patients unable to comply with study procedures and follow-up visits
  • Patients with uncontrolled medical conditions that could interfere with the study
  • Patients who have previously discontinued crizanlizumab treatment due to safety concerns
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Crizanlizumab is a medication used to treat sickle cell disease (SCD). It works by helping to prevent blood cells from sticking together and forming clots, which can cause pain and other complications in people with sickle cell disease. This medication is given through an intravenous (IV) infusion, which means it's delivered directly into the bloodstream through a vein.

What is already known about the treatment

Crizanlizumab – A monoclonal antibody medication administered through intravenous infusion, specifically designed to treat sickle cell disease (SCD). It works by binding to P-selectin, a protein that plays a key role in blood cell adhesion, thereby preventing the formation of blood cell clumps that cause painful vaso-occlusive crises in sickle cell patients. The medication belongs to the class of selective P-selectin inhibitors and represents a targeted biological therapy that has shown effectiveness in reducing the frequency of pain crises in SCD patients. Currently approved for clinical use, crizanlizumab offers a novel therapeutic approach for managing sickle cell disease by addressing one of its fundamental pathological mechanisms.

Investigated diseases

Sickle Cell Disease – A genetic blood disorder where red blood cells become rigid and take on a crescent or sickle shape instead of their normal round form. This inherited condition affects hemoglobin, the protein in red blood cells that carries oxygen throughout the body. The abnormal cells can get stuck in small blood vessels, causing pain and reducing blood flow to various parts of the body. The misshapen cells also break down more quickly than normal blood cells, which leads to anemia. People with this condition can experience periodic episodes called pain crises when blood flow becomes blocked to an area of the body. The disease is present from birth but symptoms usually begin to appear in early childhood.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510734-41-00Protocol codeCSEG101A2401BEstimated enrolment81 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.