Dupilumab for Chronic rhinosinusitis with nasal polyps

Inclusion criteria

• {"criterion_text":"- >18 years\n- Willingness to participate in the study\n- Suffer from uncontrolled CRSwNP according to EPOS criteria\n- Indication for biologic treatment in the opinion of the investigator and according to the reimbursement criteria established by the Austrian Federation of Social Insurances"}

Exclusion criteria

• {"criterion_text":"- Pregnancy (as determined by beta human chorionic gonadotropin (β-HCG) test)\n- A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study\n- Patients receiving ongoing or having received biological therapy in the last 3 months for type-2 diseases like asthma, atopic dermatitis, chronic obstructive pulmonary disease (COPD), urticaria and eosinophilic esophagitis\n- Patients who intend to achieve pregnancy within the study period\n- Systemic corticosteroid treatment within the last three months\n- Hypersensitivity to the active substance or any of the excipients in the two IMPs\n- Participation in another investigational drug trial antibodies for asthma, CRSwNP, atopic dermatitis or allergic rhinitis\n- Breastfeeding patients\n- Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity\n- Patients with permanent immunosuppression"}

Primary endpoints

• {"endpoint_text":"- The change in NPS score (0-8 points) or the change in SNOT-22 (Scale of 0-110) from baseline to 12 months.","definition_or_measurement_approach":"Change from baseline to 12 months measured by Nasal Polyp Score (NPS, 0-8) or SNOT-22 (scale 0-110)."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients with good-excellent (4-5 criteria), poor-moderate (1-3 criteria) and no response (0 criteria) according to EPOS/EUROFREA criteria during one year of therapy with Dupilumab or Tezepelumab","definition_or_measurement_approach":"Response categories according to EPOS/EUROFREA criteria over one year."}
• {"endpoint_text":"- Change in in QoL parameters (e.g., SNOT-22 score and subcategories, scale 0-110, EQ-5D-3L, scale: 5-15) and clinical parameters (e.g. NPS, scale: 0-8; ECP, 0-200µg/L) during one year of therapy with Dupilumab or Tezepelumab","definition_or_measurement_approach":"Quality of life (SNOT-22, EQ-5D-3L) and clinical parameters (NPS, ECP) change from baseline to one year."}
• {"endpoint_text":"- Change in objective (Sniffin’sticks, 0-16 points) and subjective (VAS for olfactory performance (0-10cm), SNOT 22 items) during one year of therapy with Dupilumab or Tezepelumab","definition_or_measurement_approach":"Olfactory function measured objectively by Sniffin’Sticks (0-16) and subjectively by VAS (0-10 cm) and SNOT-22 items over one year."}
• {"endpoint_text":"- change in peak nasal inspiratory flow (PNIF, 0-370 L/min) or FEV 1 (spirometer, 0-ca.120%(young patients)) during one year of therapy with Dupilumab or Tezepelumab","definition_or_measurement_approach":"Objective airway measures: PNIF (L/min) and FEV1 (%) measured over one year."}
• {"endpoint_text":"- change in perception of asthma control (ACT 0-25 Points or AQLQ 0-105 points) during one year of therapy with Dupilumab or Tezepelumab","definition_or_measurement_approach":"Patient-reported asthma control via ACT and AQLQ scores change over one year."}
• {"endpoint_text":"- change in perception of CRS symptoms (VAS, 0-10 cm) during one year of therapy with Dupilumab or Tezepelumab","definition_or_measurement_approach":"CRS symptoms measured by VAS (0-10 cm) change over one year."}
• {"endpoint_text":"- occurrence of side effect as determined by diary or patients oral report during one year of therapy with Dupilumab or Tezepelumab, change in routine blood parameters","definition_or_measurement_approach":"Safety: adverse events recorded by patient diary/oral report and routine blood parameter changes over one year."}
• {"endpoint_text":"- Change in allergic symptoms (TRSS 0-21 points, questionnaire) and allergic sensitization (skin prick test, number of sensitizations) during one year of treatment with Dupilumab or Tezepelumab","definition_or_measurement_approach":"Allergic symptoms by TRSS questionnaire and sensitization by skin prick tests over one year."}
• {"endpoint_text":"- Change in diversity (Chao1 and Shannon Index, 0-open) and abundance (0-open) of the nasal microbiome during one year of treatment with Dupilumab or Tezepelumab","definition_or_measurement_approach":"Microbiome diversity (Chao1, Shannon) and abundance measured over one year."}
• {"endpoint_text":"- Change in relative levels of mediators (Normalized Protein Expression=NPX, 0-open) as determined by OLINK during one year of treatment with Dupilumab or Tezepelumab","definition_or_measurement_approach":"Proteomic mediator levels measured by OLINK (NPX) changes over one year."}
• {"endpoint_text":"- Change in relative gene expression (Δ Cycle threshold (Ct): Difference between Ct of the target gene and a reference gene, 0-open) of oxidative stress response induced genes during one year of treatment with Dupilumab or Tezepelumab","definition_or_measurement_approach":"Gene expression (ΔCt) of oxidative stress response genes over one year."}
• {"endpoint_text":"- Change in allergic sensitization (allergen-specific IgE levels, kUA/L) in nasal secretions and serum during one year of treatment with Dupilumab or Tezepelumab","definition_or_measurement_approach":"Allergen-specific IgE levels in nasal secretions and serum measured over one year."}

Austria

Earliest CTIS Part Ii Submission Date

12-03-2026

Latest Decision Or Authorization Date

22-03-2026

Processing Time Days

10

Number Of Sites

7

Number Of Participants

220

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria