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New study tests tezepelumab for chronic sinusitis sufferers

NCT ID NCT07633158

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 26, 2026 · Updated 5 times

Summary

This study follows 200 adults with severe chronic sinusitis and nasal polyps who are starting tezepelumab as part of their routine care. Researchers will track changes in symptoms and quality of life over up to two years using patient questionnaires. The goal is to see how well the drug works in real-world settings, outside of strict clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tezepelumab
What this could lead to
If successful, this study could show that tezepelumab effectively controls symptoms and reduces the need for steroids or surgery in people with severe nasal polyps.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is also early-stage real-world evidence, and tezepelumab may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of male and female participants aged ≥ 18 years treated by ear-nose-throat specialists with diagnosed severe uncontrolled CRSwNP, for whom a tezepelumab biologic treatment for CRSwNP will be initiated in line with the applicable European Summary of Product Characteristics (SmPC) within routine clinical practice. The decision to initiate or switch to Tezepelumab must be made by the treating physician according to the participant's medical needs and a positive benefit/risk balance. Eligible patients will be included into the study after and independently of the treating physician's treatment and diagnostic decisions. Each participant should meet all the Inclusion Criteria and none of the Exclusion Criteria for this study in order to be part of the study.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * \- Participant must be 18 years of age or older, at the time of signing the informed consent. * \- Confirmed diagnosis of CRSwNP for at least 12 months prior to routine care visit 1. * \- Stable standard of care (SoC) treatment with Intranasal corticosteroids (INCS) for CRSwNP for at least 30 days prior to routine care visit 1. * \- Physician decision that participant is eligible for treatment with Tezepelumab according to locally approved CRSwNP label. * Participants must be able and willing to read and comprehend written instructions, to collect Patient-reported outcome (PROs) and medication intake via app or alternative mode (paper) and to sign the informed consent document. Use of the mobile app is optional; participants without smartphones will not be excluded. Mode of data capture will be recorded and adjusted for in analyses where relevant. * \- Participants who will be enrolled after index date need to have at least one measurement for SNOT-22 prior (within a maximum of 4 weeks) to index date. * \- - Exclusion Criteria: * \- Participants who participate in an observational study that might influence the assessment of the current study (participants can be part of the German National Registry for Chronic rhinosinusitis (GENRE-CRS)); or participate in an interventional clinical trial in the last 3 months. * \- Concurrent biologic therapy for CRSwNP or Asthma except where the last dose was administered ≥ 30 days. Stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment) is allowed. * \- Endoscopic NP surgery within 6 months prior to index date. * \- Condition (acute or chronic) that, in the investigator's opinion, would limit the participant's ability to complete questionnaires or participate in this study. * \- History of documented anaphylactic reactions/hypersensitivity/serious allergic reactions (immune complex disease) following any biologic therapy. * \- Known hypersensitivity to Tezepelumab or any of its excipients. * \- Pregnancy, planned pregnancy or lactation period. * \- -

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Conditions

The condition(s) this trial relates to.

chronic rhinosinusitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic rhinosinusitis with nasal polyps (CRSWNP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Dortmund, Germany

  • Research Site

    RECRUITING

    Hamburg, Germany

  • Research Site

    RECRUITING

    Heilbronn, Germany

  • Research Site

    RECRUITING

    Jena, Germany

  • Research Site

    RECRUITING

    Kiel, Germany

  • Research Site

    RECRUITING

    München, Germany

  • Research Site

    RECRUITING

    Neuenhagen, Germany

  • Research Site

    RECRUITING

    Rosenheim, Germany

  • Research Site

    RECRUITING

    Starnberg, Germany

  • Research Site

    RECRUITING

    Tübingen, Germany

  • Research Site

    RECRUITING

    Wiesbaden, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.