Tezepelumab CRSwNP Real World Study (CREW Study) (CREW)
24. august 2026 oppdatert av: 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.)
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: information.center@astrazeneca.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: up to 52 weeks
|
To describe changes in nasal polyp score (NPS) at each collected timepoint.
|
up to 52 weeks
|
|
Proportion of NPS responders
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 52 weeks
|
To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.
|
Up to 52 weeks
|
|
Individual goal attainment
Tidsramme: At Week 24 and Week 52
|
Proportion of participants achieving symptoms goal: SNOT-22* ≤ 20
|
At Week 24 and Week 52
|
|
Individual goal attainment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
31. oktober 2028
Studiet fullført (Antatt)
28. september 2029
Datoer for studieregistrering
Først innsendt
18. august 2026
Først innsendt som oppfylte QC-kriteriene
24. august 2026
Først lagt ut (Faktiske)
27. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D5242R00014
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
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.
Tilgangskriterier for IPD-deling
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.
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Nei
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