Tezepelumab CRSwNP Real World Study (CREW Study) (CREW)
maanantai 24. elokuuta 2026 päivittänyt: AstraZeneca
Tezepelumab CRSwNP Real World Study (CREW Study): Non-interventional Prospective, Observational Study in Patients With CRSwNP Treated by Tezepelumab, Evaluating Patient-reported Outcomes in Japan Real World Practice.
The CREW Study is a non-interventional prospective, observational study in patients with CRSwNP that will evaluate patient-reported outcomes and describe the proportion of participants achieving treatment goals.)
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Interventio / Hoito
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Arvioitu)
100
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: AstraZeneca Clinical Study Information Center
- Puhelinnumero: 1-877-240-9479
- Sähköposti: information.center@astrazeneca.com
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
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.
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
Tezepelumab Treatment Group
Adult patients with severe CRSwNP who are newly initiated on subcutaneous (SC) tezepelumab.
Eligible participants are those for whom therapy with systemic corticosteroids and/or surgery does not provide adequate disease control.
|
Subcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Aikaikkuna: at 24 weeks from initiation of tezepelumab treatment.
|
To describe the changes in participant-reported sinonasal symptoms as evaluated by sinonasal outcome test, 22 item (SNOT-22) total score.
|
at 24 weeks from initiation of tezepelumab treatment.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Aikaikkuna: at 4, 12, and 52 weeks from initiation of tezepelumab treatment
|
To describe the changes in participant-reported sinonasal symptoms as SNOT-22 total score following initiation of tezepelumab treatment.
|
at 4, 12, and 52 weeks from initiation of tezepelumab treatment
|
|
Proportion of tezepelumab SNOT-22 responders
Aikaikkuna: up to 52 weeks
|
Proportion of responders in sinonasal symptoms as evaluated by SNOT-22 total score, defined as patients achieving the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint.
|
up to 52 weeks
|
|
Odds to achieve tezepelumab SNOT-22 response
Aikaikkuna: up to 52 weeks
|
Odds to achieve tezepelumab SNOT-22 response meeting or exceeding the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint.
|
up to 52 weeks
|
|
Median time to first MCID-defined responder in sinonasal symptoms
Aikaikkuna: up to 52 weeks
|
To describe time to response in sinonasal symptoms as evaluated by SNOT-22 total score (time from baseline to the first occurrence of ≥ 8.9-point decrease).
|
up to 52 weeks
|
|
Mean change from baseline in nasal blockage (NB) measured by VAS-NB
Aikaikkuna: up to 52 weeks
|
To describe changes in nasal blockage (NB) as evaluated by a visual analogue scale (VAS-NB) at each collected timepoint.
|
up to 52 weeks
|
|
Proportion of NB responders
Aikaikkuna: up to 52 weeks
|
To describe proportion of NB responders, defined as patients achieving the MCID (≥ 3.0-point decrease from baseline; in participants with VAS-NB ≥ 7 at baseline) at each collected timepoint.
|
up to 52 weeks
|
|
Median time to meeting or exceeding the MCID for VAS-NB
Aikaikkuna: up to 52 weeks
|
Median time from baseline to the first occurrence of a ≥3.0-point decrease by each collected timepoint in participants with VAS-NB ≥ 7 at baseline.
|
up to 52 weeks
|
|
Mean change from baseline in sense of smell score by VAS-smell
Aikaikkuna: up to 52 weeks
|
To describe changes in sense of smell as evaluated by VAS-Smell
|
up to 52 weeks
|
|
Proportion of VAS-Smell responders
Aikaikkuna: up to 52 weeks
|
Proportion of VAS-Smell responders, defined as patients achieving the MCID (≥ 3.0-point decrease from baseline) in participants with VAS-Smell ≥ 7 at baseline at each collected timepoint.
|
up to 52 weeks
|
|
Median time to meeting or exceeding the MCID for VAS-Smell
Aikaikkuna: up to 52 weeks
|
Median time from baseline to the first occurrence of a ≥3.0-point decrease by each collected timepoint in participants with VAS-Smell ≥ 7 at baseline.
|
up to 52 weeks
|
|
Mean change from baseline in NP severity as measured by VAS-NP symptoms
Aikaikkuna: up to 52 weeks
|
To describe changes in NP severity (VAS-NP) at each collected timepoint.
|
up to 52 weeks
|
|
Proportion of VAS-NP symptom responders
Aikaikkuna: up to 52 weeks
|
To describe responders proportion of VAS-NP symptom responders, defined as patients achieving the MCID (≥ 2.5-point decrease from baseline) at each collected timepoint.
|
up to 52 weeks
|
|
Median time to meeting or exceeding the MCID for VAS-NP symptom
Aikaikkuna: up to 52 weeks
|
Median time from baseline to the first occurrence of a ≥2.5-point decrease by each collected timepoint.
|
up to 52 weeks
|
|
Mean change from baseline in total NPS evaluated by nasal endoscopy
Aikaikkuna: up to 52 weeks
|
To describe changes in nasal polyp score (NPS) at each collected timepoint.
|
up to 52 weeks
|
|
Proportion of NPS responders
Aikaikkuna: up to 52 weeks
|
To describe proportion of NPS responders, defined as patients achieving the MCID (≥ 1.0-point decrease from baseline).
|
up to 52 weeks
|
|
Median time to meeting or exceeding the MCID for NPS
Aikaikkuna: up to 52 weeks
|
To describe median time to meeting or exceeding the MCID for NPS by each collected timepoint.
|
up to 52 weeks
|
|
Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question
Aikaikkuna: up to 52 weeks
|
To describe responder proportion for NP control.
|
up to 52 weeks
|
|
Median time to first attainment of NP well control or NP complete control
Aikaikkuna: up to 52 weeks
|
To describe median time to first attainment of NP well control or NP complete control by each collected timepoint.
|
up to 52 weeks
|
|
Average SCS daily dose after initiating tezepelumab
Aikaikkuna: From baseline up to 24 weeks and from baseline up to 52 weeks
|
To describe overall systemic steroid use in participants, measured as average SCS daily dose (e.g., prednisone-equivalent milligrams).
|
From baseline up to 24 weeks and from baseline up to 52 weeks
|
|
Proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use
Aikaikkuna: From baseline up to 24 weeks and from baseline up to 52 weeks
|
To describe proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use.
|
From baseline up to 24 weeks and from baseline up to 52 weeks
|
|
Number of patients with ≥ 100, 200 and 400 mg cumulative SCS
Aikaikkuna: From baseline up to 24 weeks and from baseline up to 52 weeks
|
Number of patients with ≥ 100, 200 and 400 mg cumulative SCS (e.g., prednisone-equivalent milligrams).
|
From baseline up to 24 weeks and from baseline up to 52 weeks
|
|
Time-to-first disease-related SCS use
Aikaikkuna: From baseline up to 24 weeks and from baseline up to 52 weeks
|
Time-to-first disease-related SCS use, with cumulative incidence CRSwNP-related SCS use, asthma-related SCS use, other indications related SCS use and unknown indication-related SCS use.
|
From baseline up to 24 weeks and from baseline up to 52 weeks
|
|
Proportion of participants with AEs, SAEs, DAEs, and AESIs
Aikaikkuna: Up to 52 weeks
|
To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.
|
Up to 52 weeks
|
|
Individual goal attainment
Aikaikkuna: At Week 24 and Week 52
|
Proportion of participants achieving symptoms goal: SNOT-22* ≤ 20
|
At Week 24 and Week 52
|
|
Individual goal attainment
Aikaikkuna: At Week 24 and Week 52
|
Proportion of participants achieving Exacerbations goal: No SCS for sino-nasal exacerbations
|
At Week 24 and Week 52
|
|
Individual goal attainment
Aikaikkuna: At Week 24 and Week 52
|
Proportion of participants achieving Surgery goal: No sino-nasal surgery
|
At Week 24 and Week 52
|
|
Individual goal attainment
Aikaikkuna: At Week 24 and Week 52
|
Proportion of participants achieving Polyp burden goal: NPS improvement or NPS ≤2
|
At Week 24 and Week 52
|
|
Individual goal attainment
Aikaikkuna: At Week 24 and Week 52
|
Proportion of participants achieving olfaction goal: Smell PRO improvement following initiation of tezepelumab
|
At Week 24 and Week 52
|
|
Composite goal attainment
Aikaikkuna: At Week 24 and Week 52
|
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery
|
At Week 24 and Week 52
|
|
Composite goal attainment
Aikaikkuna: At Week 24 and Week 52
|
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/polyp
|
At Week 24 and Week 52
|
|
Composite goal attainment
Aikaikkuna: At Week 24 and Week 52
|
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/olfaction
|
At Week 24 and Week 52
|
|
Composite goal attainment
Aikaikkuna: At Week 24 and Week 52
|
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/polyp burden/olfaction
|
At Week 24 and Week 52
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Torstai 1. lokakuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Tiistai 31. lokakuuta 2028
Opintojen valmistuminen (Arvioitu)
Perjantai 28. syyskuuta 2029
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 18. elokuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 24. elokuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Torstai 27. elokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Torstai 27. elokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 24. elokuuta 2026
Viimeksi vahvistettu
Lauantai 1. elokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- D5242R00014
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org.
All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
does not contain a plan to share individual participant data.
IPD-jaon aikakehys
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD-jaon käyttöoikeuskriteerit
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Yhdysvalloissa valmistettu ja sieltä viety tuote
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .