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Comparison of dupilumab and tezepelumab for the treatment of chronic rhinosinusitis with nasal polyps.

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

This study is designed to compare the effectiveness of two different medications for treating Chronic Rhinosinusitis with Nasal Polyps. This condition involves long-term inflammation of the sinuses and the growth of noncancerous growths, called nasal polyps, inside the nasal passages. The two medications being studied are dupilumab and tezepelumab, which are both administered through a subcutaneous injection, meaning they are injected into the fatty tissue just under the skin.

The purpose of the study is to determine which of these two drugs provides a better improvement in symptoms related to the nasal polyp disease. Over a period of 12 months, participants will receive one of the medications to see how it affects their breathing, their sense of smell, and their overall quality of life. The study will monitor various changes in symptoms and physical health to evaluate how well each treatment works in a real-world setting.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of treatment

    After joining the study, one of two medications will be administered via subcutaneous injection, which is an injection into the fatty tissue just under the skin.

    The first option is dupilumab, given as a 300 mg dose.

    The second option is tezepelumab, given as a 210 mg dose.

  2. Step 2

    Monitoring and evaluation

    Over the course of 12 months, various assessments will be performed to track the condition of chronic rhinosinusitis with nasal polyps, which is a long-term inflammation of the nose and sinuses involving growths called polyps.

    Measurements will be taken regarding the nasal polyp score, which rates the size of the polyps, and the snot-22, which is a questionnaire used to assess how symptoms affect daily life.

    Assessments will include checking smell perception through tests and scales, as well as measuring nasal airflow.

    Lung function may be measured using a spirometer, a device that tracks how much air can be inhaled and exhaled.

    Regular tracking of asthma control and allergic symptoms will be conducted through specific questionnaires.

    Any side effects are to be recorded in a diary or reported orally.

    Biological samples such as nasal secretions and blood will be collected to monitor allergy levels, inflammation markers, and changes in the nasal microbiome, which refers to the microscopic organisms living in the nose.

Who can join the trial?

6 criteria

  • You must be older than 18 years of age.
  • You must be willing to take part in this research study.
  • You must have Chronic Rhinosinusitis with Nasal Polyps, which is a long-term swelling and inflammation of the sinuses (the hollow spaces in your face) and the nasal passages, accompanied by small, non-cancerous growths called nasal polyps.
  • Your condition must be considered uncontrolled, meaning your current symptoms are not well-managed by your existing treatments.
  • The study doctor must believe you are a suitable candidate for biologic treatment, which is a type of medicine made from living organisms designed to target specific parts of the immune system to treat disease.
  • Your need for treatment must meet the specific reimbursement criteria (the rules used to decide if medical costs are covered) set by the Austrian Federation of Social Insurances.

Who cannot join the trial?

10 criteria

  • Being pregnant, which is confirmed by a blood test that checks for a specific hormone called beta human chorionic gonadotropin (β-HCG).
  • Having a mental health condition that makes it difficult to understand the purpose, details, or potential results of the study.
  • Currently taking, or having taken within the last 3 months, biological therapy, which is a type of medicine made from living organisms, for conditions such as asthma, atopic dermatitis (skin inflammation), chronic obstructive pulmonary disease (COPD) (a lung disease that makes breathing difficult), urticaria (hives), or eosinophilic esophagitis (inflammation of the food pipe).
  • Planning to become pregnant during the time the study is being conducted.
  • Having used systemic corticosteroids, which are strong anti-inflammatory medicines that travel through the whole body, within the last three months.
  • Having an allergy or hypersensitivity to the main medicine or any of the excipients, which are the inactive ingredients used to make the medicine.
  • Participating in another study involving investigational drugs, which are medicines that are still being tested, for conditions like asthma, nasal polyp disease, skin inflammation, or allergic rhinitis (hay fever).
  • Currently breastfeeding.
  • Having significant anatomic variations, which means the physical shape of your nose is unusual, making it impossible to reach all areas of the nasal cavity (the inside of the nose).
  • Having permanent immunosuppression, which is a long-term condition where your body's immune system (the system that fights infections) is weakened.
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Investigated drugs

  • Dupixent

    is an injectable medication used to treat inflammation. In this study, it is being tested to see how well it helps reduce symptoms and the size of nasal polyps.

  • Tezspire

    is an injectable medication designed to target specific parts of the immune system to reduce inflammation. This study evaluates its effectiveness in improving nasal polyp disease.

What is already known about the treatment

  • Dupilumab

    This medication is administered as a liquid through a small injection under the skin. It is an established treatment used to manage conditions like chronic rhinosinusitis with nasal polyps by blocking specific proteins that trigger inflammation. At a molecular level, it works by interfering with a signaling pathway that tells the body to produce certain inflammatory cells. It is classified as a monoclonal antibody designed to calm an overactive immune response.

  • Tezepelumab

    This medication is given as a liquid injection directly under the skin. It is a recognized therapeutic option used to treat severe asthma and related inflammatory conditions. It works by binding to a specific molecule called TSLP, which acts like a master switch to start the body's inflammatory process. It is pharmacologically classified as a monoclonal antibody that stops inflammation before it can fully begin.

Investigated diseases

Chronic Rhinosinusitis with Nasal Polyps - This condition involves long-term inflammation of the sinuses and nasal passages. It is characterized by the growth of noncancerous growths called polyps on the lining of the nasal cavity or sinuses. These polyps can increase in size and number over time. As the disease progresses, the polyps may cause significant blockage in the nasal passages. This blockage can lead to difficulties with breathing and a reduced sense of smell.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524495-39-00Protocol codeDIRECTIONEstimated enrolment294 patientsSponsorMedical University Of Vienna

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