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Tezepelumab CRSwNP Real World Study (CREW Study) (CREW)

24 augustus 2026 bijgewerkt door: 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.)

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

100

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Geneesmiddel: Tezepelumab
Subcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care.
Andere namen:
  • Tezspire

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: up to 52 weeks
To describe changes in nasal polyp score (NPS) at each collected timepoint.
up to 52 weeks
Proportion of NPS responders
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to 52 weeks
To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.
Up to 52 weeks
Individual goal attainment
Tijdsspanne: At Week 24 and Week 52
Proportion of participants achieving symptoms goal: SNOT-22* ≤ 20
At Week 24 and Week 52
Individual goal attainment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AstraZeneca

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

31 oktober 2028

Studie voltooiing (Geschat)

28 september 2029

Studieregistratiedata

Eerst ingediend

18 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 augustus 2026

Eerst geplaatst (Werkelijk)

27 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

24 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • D5242R00014

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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-toegangscriteria voor delen

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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