BridgeMD
DIRECTION Study
EU CTIS ID: 2025-524495-39-00
What this study is testing
To demonstrate that Tezepelumab and Dupilumab lead 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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- >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
You likely can't join if
- Pregnancy (as determined by beta human chorionic gonadotropin (β-HCG) test)
- A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- 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
- Patients who intend to achieve pregnancy within the study period
- Systemic corticosteroid treatment within the last three months
- Hypersensitivity to the active substance or any of the excipients in the two IMPs
See the full eligibility criteria
- >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
- Pregnancy (as determined by beta human chorionic gonadotropin (β-HCG) test)
- A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- 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
- Patients who intend to achieve pregnancy within the study period
- Systemic corticosteroid treatment within the last three months
- Hypersensitivity to the active substance or any of the excipients in the two IMPs
- Participation in another investigational drug trial antibodies for asthma, CRSwNP, atopic dermatitis or allergic rhinitis
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.