Can a biologic drug ease the burden of severe nasal polyps?
NCT ID NCT07790198
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This study follows about 100 adults in Japan who have severe chronic sinusitis with nasal polyps and are starting treatment with tezepelumab, a biologic given as a shot. Researchers will track how symptoms and quality of life change over time using a standard questionnaire called SNOT-22. The goal is to see how well the drug works in real-world settings, outside of a controlled clinical trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tezepelumab (Tezspire), an add-on biologic therapy for severe chronic rhinosinusitis with nasal polyps
- What this could lead to
- If symptoms improve, this could support tezepelumab as a practical option for people with severe nasal polyps who need better control of their condition.
- What could go wrong
- This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply beyond the Japanese population studied.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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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 with diagnosed severe uncontrolled CRSwNP, for whom a tezepelumab biologic treatment for CRSWNP will be initiated. Eligible participant will be identified in routine care and enrolled prospectively at participating sites.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 * Participants who will be enrolled after index date need to have at least SNOT-22 prior (maximum of 4 weeks) to index date * Documented SNOT-22 total score\>=30, collected within the 4 weeks prior to the first tezepelumab dose (index date) * Treated per the Japanese Handbook for the Management of Chronic Rhinosinusitis with Nasal Polyps for at least 30 days prior to routine care visit 1 * Physician decision that participant is eligible for treatment with tezepelumab according to local approved CRSwNP label and Optimal Clinical Use Guidelines * Patients must be able and willing to read and comprehend written instructions, to collect PROs and medication intake and to sign the informed consent document Exclusion Criteria: * Patients who participate in an interventional clinical trial in the last 4 months * Known hypersensitivity to tezepelumab or any of its excipients * Patients who have received any biologic therapy for asthma or CRSwNP * Condition (acute or chronic) that, in the investigator's opinion, would limit the participant´s ability to complete questionnaires or participate in this study * Pregnancy or lactation period or planning pregnancy during the study period
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Triple-Action nasal spray could ease chronic sinusitis
- 3D-Printed nose models could boost sinus rinse results
- Sinus surgery may ease sleep problems in nasal polyp patients
- Real-World check: do new biologics really help severe nasal polyps?