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Not yet recruitingPhase 4

Comparing tezepelumab and dupilumab for chronic rhinosinusitis with nasal polyps

Compares tezepelumab with dupilumab in adults who have chronic rhinosinusitis with nasal polyps.

Key facts

Who runs it
Medical University Of Vienna
Where
Austria8 sites in 1 countryChoose a country to see its sites
Registry title
DIRECTION Study
Status
Not yet recruiting
Phase
Phase 4
People taking part
294 people, planned
Started
1 Jun 2026
Expected to end
1 Jun 2028
Type of study
Interventional
Record updated
4 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic sinus inflammation with nasal polyps (CRSwNP) that is not under control. It compares Tezepelumab and Dupilumab.

Age
Over 18 years
Sex
All sexes
Disease stage
Uncontrolled CRSwNP according to EPOS criteria. The study doctor must judge that a biologic treatment is needed, following Austrian reimbursement rules.
Earlier treatment
People must have had surgery for CRSwNP before and not responded well enough to corticosteroid tablets or injections. No biologic therapy for type-2 diseases and no systemic corticosteroids in the last 3 months.

Main reasons for not taking part

  • Pregnancy, planning a pregnancy during the study, or breastfeeding
  • Biologic therapy for asthma, atopic dermatitis, COPD, urticaria or eosinophilic esophagitis now or in the last 3 months
  • Systemic corticosteroid treatment in the last three months
  • Allergy to either study drug or its ingredients
  • Permanent immunosuppression, or severe nose anatomy changes that block access to all areas of the nasal cavity

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • >18 years
  • Willingness to participate in the study
  • Suffer from uncontrolled CRSwNP according to EPOS criteria
  • Indication for biologic treatment in the opinion of the investigator and according to the reimbursement criteria established by the Austrian Federation of Social Insurances: *History of surgical treatment for CRSwNP *Inadequate response to systemic corticosteroid treatment

Who cannot take part

  • 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
  • Systemic corticosteroid treatment within the last three months
  • Participation in another investigational drug trial antibodies for asthma, CRSwNP, atopic dermatitis or allergic rhinitis
  • A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
  • Hypersensitivity to the active substance or any of the excipients in the two IMPs
  • Pregnancy (as determined by beta human chorionic gonadotropin (β-HCG) test)
  • Patients who intend to achieve pregnancy within the study period
  • Breastfeeding patients
  • Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity
  • Patients with permanent immunosuppression

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

To compare Tezepelumab and Dupilumab with respect to a clinical meaningful improvement of nasal polyp disease as defined by a minimal reduction of nasal polyp score (NPS) by 1 point or a reduction in sino-nasal outcome test SNOT)-22 by 8.9 points between baseline and 12 months

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Direct comparison of Tezepelumab and Dupilumab in CRSwNP in a real world setting
Plain-language title
Comparing tezepelumab and dupilumab for chronic rhinosinusitis with nasal polypsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
4 September 2026