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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Medical University Of Graz Graz Austria

Other Sites

Site Name City Country Status
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
Kepler Universitaetsklinikum GmbH Linz Austria
Uniklinikum Salzburg Salzburg Austria
Ougtbmbhsuctlu Lwex Gjsz Linz Austria
Toccjbdmjnmxaa Gqlr Zell Am See Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.06.2026

Trial locations

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.

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 ID:
2025-524495-39-00
Protocol code:
DIRECTION
Trial Phase:
Therapeutic confirmatory (Phase III)

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