TezeBarrier Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09]

Trial duration

25 Sep 2025 → ongoing

Decision date (initial)

2025-03-03

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To determine the effect of Tezepelumab treatment on the barrier function of upper and lower airways in patients suffering from severe asthma with CRSwNP and without CRS and elevated T2 biomarkers. This will be achieved by analysis of epithelial barrier function upon challenge with various harmful substances (e.g. cigarette smoke extract, allergens, and PolyIC) in cultured primary respiratory tract epithelial cells using the xCELLigence system for continuous monitoring of barrier function.

Conditions and MedDRA coding

severe asthma and chronic rhinosinusitis with nasal polyps

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Provision of informed consent prior to any study specific procedures
2. Age 18-99 years and willing to participate in the study
3. Have a recorded clinical diagnosis of asthma (ICD-10 Code: J45)
4. Undergo severe asthma treatment according to GINA/DAL treatment step 4 or 5
5. Meet the requirements for treatment of severe asthma with Tezepelumab defined as: - severe asthma that remains uncontrolled despite a high dosage of ICS/LABA, or that requires a high dose to prevent it from becoming uncontrolled. One of the following criteria needs to be fulfilled: • ACT <20, ACQ>0.75 • During the last 12 months 2 courses of OCS for at least 3 days due to severe asthma symptoms • During last 12 months one exacerbation requiring hospitalization • Lung function: FEV1 <80% predicted - FeNO ≥ 20 ppB - had either ≥250 eosinophils /µl measured in the blood OR measurement of blood eosinophils ≥150 cells during reduction of OCS dosing or high dose ICS and/or one measurement of sputum eosinophils > 2% or BAL eosinophils > 2% - Group with polyps: Presence of nasal polyps as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and Nasal Polyps Guidelines
6. mucus score of ≥ 1
7. Patients with a history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a washout period of 3 half-lives or 3 months have passed (whichever is longer)

Exclusion criteria 12

1. Patients with current therapy with biologics as well as therapy with biologics 12 weeks (3 half-lives) before the start of the study or history of therapy with tezepelumab
2. Pregnancy (as determined by urine pregnancy test)
3. Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity or to perform bronchoscopy
4. Patients with any other confounding underlying lung disorder including but not limited to: o Bronchiectasis, pulmonary fibrosis, emphysema, primary ciliary dyskinesia o Cystic fibrosis, any known parasitic infections and lung cancer
5. Patients with other causes of nasal polyps than Type 2 CRS inflammation
6. Patients with pulmonary conditions with symptoms of asthma and blood eosinophilia including but not limited to: Eosinophilic granulomatosis with polyangiitis (EGPA) allergic bronchopulmonary aspergillus and hypereosinophilic syndrome
7. Contraindications for endobronchial and/or transbronchial biopsy
8. A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
9. Patients with clinically meaningful comorbidity as determined by the evaluating committee
10. Immunosuppressive treatment (e.g. cyclosporine)
11. Drug and alcohol abuse
12. Current smoker and former smokers if stopped smoking <6 months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Changes in normalized cell index in response to barrier-damaging substances in cultured primary epithelial cells of the different disease entities using the xCELLigence system for continuous monitoring of barrier function.

Secondary endpoints 6

1. Mucus plugging: CT scan
2. Cellular composition: percentage of populations and mean metal intensity (marker expression)
3. Inflammatory mediator expression: Levels (e.g. ng/mL)
4. Microbiome: Composition, Diversity Indices
5. Tight junction protein staining: mean fluorescence intensity
6. Association: Pearson or Spearman-rank correlation coefficient depending on data distribution

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Department of Pneumology

Public contact point

Organisation

Medical University Of Vienna

Contact name

Department of Pneumology

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications