Tezepelumab CRSwNP Real World Study (CREW Study) (CREW)
24 de agosto de 2026 atualizado por: 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.)
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Estimado)
100
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: AstraZeneca Clinical Study Information Center
- Número de telefone: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: up to 52 weeks
|
To describe changes in nasal polyp score (NPS) at each collected timepoint.
|
up to 52 weeks
|
|
Proportion of NPS responders
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Up to 52 weeks
|
To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.
|
Up to 52 weeks
|
|
Individual goal attainment
Prazo: At Week 24 and Week 52
|
Proportion of participants achieving symptoms goal: SNOT-22* ≤ 20
|
At Week 24 and Week 52
|
|
Individual goal attainment
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de outubro de 2026
Conclusão Primária (Estimado)
31 de outubro de 2028
Conclusão do estudo (Estimado)
28 de setembro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
18 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de agosto de 2026
Primeira postagem (Real)
27 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D5242R00014
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
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.
Critérios de acesso de compartilhamento IPD
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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .