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Safety and Tolerability of Benralizumab in Patients with HES, EGPA, or Asthma Who Completed a Prior Study

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study involves people with conditions that cause high numbers of a type of white blood cell called eosinophils. These conditions include Hypereosinophilic Syndrome, Eosinophilic Granulomatosis with Polyangiitis, and asthma. The medication being used is benralizumab, which is given as a small injection under the skin (subcutaneous injection) and works by reducing eosinophil activity.

The purpose of the study is to continue providing benralizumab to individuals who have already shown benefit and to monitor its long‑term safety and how well it is tolerated. After completing the earlier trial, participants will receive regular injections of the medication for an extended period, with scheduled clinic visits where doctors check for any side effects or health changes and collect safety information. The study will end several weeks after the last dose is given.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    You will meet the study staff to confirm that you have completed a previous benralizumab study and that the investigator believes you continue to benefit. you will be asked to read and sign a consent form that explains the purpose of the roll‑over study and what will be required of you.

  2. Step 2

    Baseline medical evaluation

    Before receiving any medication, the study team will collect information about your health, including a physical exam, laboratory tests, and a review of your current symptoms of hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, or asthma. this information establishes a starting point for later comparisons.

  3. Step 3

    First injection of <b>benralizumab</b>

    You will receive a subcutaneous injection (an injection under the skin) of the 30 mg benralizumab solution (brand name faserna) using a pre‑filled syringe. the dose is 30 mg per injection. the exact timing of this first dose follows the schedule set by the study protocol.

  4. Step 4

    Scheduled follow‑up visits and additional injections

    You will return to the study site at regular intervals defined by the protocol. at each visit you will:

    • undergo safety assessments such as vital signs and laboratory tests,

    • report any new symptoms or side effects,

    • receive the next subcutaneous injection of 30 mg benralizumab according to the study schedule.

  5. Step 5

    Ongoing safety monitoring

    Throughout the study you are asked to inform the study staff of any adverse events, whether serious or not serious. the investigators will record and evaluate these events to assess the long‑term safety of benralizumab.

  6. Step 6

    Final study visit and last injection

    When the predetermined study period ends, you will attend a final visit. during this visit you will receive the last scheduled injection of 30 mg benralizumab, complete any remaining questionnaires, and undergo a final set of safety assessments.

  7. Step 7

    Post‑treatment safety follow‑up (8 weeks)

    After the last injection, the study continues to monitor your safety for an additional eight weeks. you will have at least one follow‑up contact during this period to report any delayed side effects and to perform final laboratory checks.

Who can join the trial?

6 criteria

  • You must sign and date a written Informed Consent Form (ICF), which shows you understand the study and agree to take part.
  • You must have completed the required Open‑Label Extension (OLE) period of the earlier study, and the doctor must think you are still benefiting from the medication.
  • You must agree to follow the birth‑control (contraception) rules set by the study, from the time you join until 12 weeks after your last dose.
  • If you cannot have children now, you must agree to start appropriate birth‑control if you later become able to have children, and continue it until 12 weeks after your last dose.
  • You must need the medicine benralizumab and be unable to obtain it on your own outside the study.
  • Both men and women can join, including children, as long as they meet the other requirements.

Who cannot join the trial?

7 criteria

  • Unresolved adverse event that required stopping treatment at the end of the previous study, and the doctor believes it would prevent you from starting the medication again. (Adverse event means a side effect or health problem caused by a treatment.)
  • Planning to receive any live or live‑attenuated vaccine, which are vaccines that contain weakened or active germs.
  • Planning to use other biologic medicines, such as treatments that target B‑cells, unless they are the only option for another health problem you have. (Biologic medicines are drugs made from living cells that affect the immune system; B‑cells are a type of white blood cell that helps produce antibodies.)
  • Having any other serious medical illness (for example, cancer or a viral infection like hepatitis) or a mental health condition that the doctor believes would make it unsafe or difficult for you to stay in the study. (Psychiatric condition refers to mental health disorders such as depression or anxiety.)
  • Being enrolled in another clinical trial at the same time (except the original parent study you finished).
  • Leaving the previous study before completing the required minimum treatment period.
  • Having easy access to the study drug (benralizumab) outside the trial, such as being able to obtain it locally on your own.
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Investigated drugs

Benralizumab is a medicine given as a small injection under the skin. It works by targeting a specific type of white blood cell that can cause inflammation in the lungs. By reducing these cells, the drug helps people with certain types of asthma breathe more easily and have fewer asthma attacks. In this study, participants who already felt better after using the medicine continue to receive it so researchers can watch how safe it is over a longer time and see how well it continues to work.

What is already known about the treatment

  • Fasenra 30 mg solution for injection in pre-filled syringe

    This medication is supplied as a ready‑to‑use liquid that is injected under the skin with a pre‑filled syringe. Benralizumab, the active ingredient, is an approved drug that has been widely studied and is listed in medical references for asthma and rare eosinophilic disorders. It is mainly used to treat severe asthma, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis. The drug works by attaching to the IL‑5 receptor on certain white blood cells, causing their removal, and it belongs to the anti‑IL‑5 receptor monoclonal antibody class.

  • Benralizumab

    Benralizumab is provided as a sterile solution for subcutaneous injection, usually given with a syringe. It is a marketed biologic that has received regulatory approval and is described in the medical literature for asthma and rare eosinophilic conditions. The main uses are severe asthma, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis. It acts by binding to the IL‑5 receptor on eosinophils, leading to their destruction, and it is classified as an anti‑IL‑5 receptor monoclonal antibody.

Investigated diseases

  • Hypereosinophilic syndrome (HES)

    A condition in which the blood contains an abnormally high number of eosinophils for a prolonged period. The excess eosinophils can infiltrate various organs such as the heart, lungs, skin, and gastrointestinal tract. Over time, this infiltration may lead to tissue damage and functional impairment. Symptoms often develop gradually and can include fatigue, rash, and shortness of breath. The disease course varies, but without control the organ involvement can become more extensive.

  • Eosinophilic granulomatosis with polyangiitis (EGPA)

    An inflammatory disorder that affects small blood vessels and is associated with high eosinophil counts. It usually begins with asthma-like symptoms and allergic rhinitis, then progresses to a vasculitic phase that can involve nerves, skin, and other organs. The vasculitic phase may cause numbness, skin purpura, and abdominal pain. Organ involvement tends to increase as the disease advances, and relapses can occur after periods of stability.

  • Asthma

    A chronic disease marked by inflammation and narrowing of the airways, leading to wheezing, coughing, and difficulty breathing. Triggers such as allergens, cold air, or exercise can worsen symptoms. Repeated episodes may cause the airway walls to thicken, reducing lung function over time. Symptoms can fluctuate daily and may become more persistent if the underlying inflammation is not managed.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523307-29-00Protocol codeD3250N00036Estimated enrolment346 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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