Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Benralizumab and Mometasone Furoate for Patients with Severe Eosinophilic Chronic Rhinosinusitis with Nasal Polyps and Asthma

Verified siteRegistered drug
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 clinical trial is focused on studying the effects of a medication called benralizumab in patients with a condition known as eosinophilic chronic rhinosinusitis with nasal polyps. This condition involves long-term inflammation of the sinuses and the growth of polyps in the nasal passages, which can lead to symptoms like nasal blockage and difficulty breathing. The study will compare the effects of benralizumab, which is given as an injection under the skin, to a placebo. Another medication, mometasone furoate, a nasal spray, is also involved in the study.

The purpose of the study is to evaluate how well benralizumab can reduce the size of nasal polyps and improve symptoms such as nasal blockage. Participants will receive either benralizumab or a placebo over a period of time, and their progress will be monitored through regular check-ups. The study will also look at other factors, such as changes in the sense of smell and the need for surgery or additional medication.

Throughout the study, participants will be asked to report their symptoms and any changes they experience. The study aims to provide valuable information on the effectiveness and safety of benralizumab for treating eosinophilic chronic rhinosinusitis with nasal polyps, potentially offering a new treatment option for those affected by this condition.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and current symptoms.

    Eligibility criteria include being between 18 to 75 years old, having a history of nasal polyps and asthma, and ongoing symptoms for at least 12 weeks.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is performed to measure the severity of nasal polyps and nasal blockage. This involves nasal endoscopy and patient-reported scores.

    The nasal polyp score (NPS) and nasal blockage score (NBS) are recorded to establish a starting point for the study.

  3. Step 3

    Treatment phase

    Participants are randomly assigned to receive either benralizumab or a placebo. Benralizumab is administered as a 30 mg solution for injection under the skin.

    The treatment is given at regular intervals as specified by the study protocol.

  4. Step 4

    Ongoing assessments

    Throughout the study, regular assessments are conducted to monitor changes in nasal polyp size and nasal blockage.

    Participants report any changes in symptoms, including difficulty with the sense of smell and overall nasal symptoms.

  5. Step 5

    Final evaluation

    At the end of the study period, a final evaluation is conducted to assess the overall effectiveness of the treatment.

    This includes a comparison of the initial and final nasal polyp scores and nasal blockage scores.

Who can join the trial?

10 criteria

  • Must be a female or male aged between 18 and 75 years old.
  • Must have a **blood eosinophil count** greater than 2% or at least 150 cells per microliter. Eosinophils are a type of white blood cell involved in allergic reactions and asthma.
  • Must have been using **intranasal corticosteroids (INCS)**, which are medications sprayed into the nose to reduce inflammation, for at least 4 weeks before joining the study and continue using them during the screening period.
  • Must have a history of using **systemic corticosteroids (SCS)**, which are medications taken by mouth or injection to reduce inflammation, or have had surgery for **CRSwNP** (chronic rhinosinusitis with nasal polyps).
  • Must have **bilateral sinonasal polyposis**, meaning nasal polyps in both nostrils, with a **nasal polyp score (NPS)** of 5 at the time of joining the study and randomization. Each nostril should have a score of at least 2.
  • Must have had ongoing symptoms for at least 12 weeks before joining the study.
  • Must report a **moderate to severe nasal blockage score (NBS)** of 2 or more at the time of joining the study. This score reflects how blocked the nose feels.
  • Must have a bi-weekly average NBS of 1.5 or more at the time of randomization.
  • Must have a **SNOT-22 total score** of 20 or more at the time of joining the study and randomization. SNOT-22 is a questionnaire that measures the impact of sinus symptoms on quality of life.
  • Must have a documented diagnosis of asthma by a physician.

Who cannot join the trial?

5 criteria

  • Patients who do not have severe CRSwNP (Chronic Rhinosinusitis with Nasal Polyps) and asthma.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not male or female, as both genders are included.
  • Patients who are not considered part of a vulnerable population.
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

Benralizumab is a medication used in this clinical trial to treat patients with eosinophilic chronic rhinosinusitis with nasal polyps. It works by targeting and reducing the number of eosinophils, which are a type of white blood cell that can contribute to inflammation and the formation of nasal polyps. The goal of using benralizumab in this study is to decrease the size of nasal polyps and improve symptoms like nasal blockage, as reported by patients.

What is already known about the treatment

Benralizumab – This medication is administered via injection and is currently being studied in clinical trials for its effectiveness in treating patients with severe eosinophilic chronic rhinosinusitis with nasal polyps, particularly those who also have asthma. Benralizumab is an antibody that targets and reduces eosinophils, a type of white blood cell involved in inflammation, by binding to the interleukin-5 receptor on their surface. It is classified as a monoclonal antibody and is being evaluated for its ability to decrease nasal polyp size and improve symptoms like nasal blockage.

Investigated diseases

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) – This condition is characterized by the inflammation of the nasal passages and sinuses, leading to the growth of polyps. These polyps can cause nasal blockage, a reduced sense of smell, and facial pressure. The disease often progresses with persistent symptoms that can affect breathing and quality of life. It is commonly associated with other respiratory conditions, such as asthma. Over time, the polyps may increase in size, potentially requiring surgical intervention if they cause significant obstruction or discomfort.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507987-38-00Protocol codeD3252C00002Estimated enrolment295 patientsSponsorAstraZeneca AB

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.