Tezepelumab CRSwNP Real World Study (CREW Study) (CREW)
24 de agosto de 2026 actualizado 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.)
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
100
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: AstraZeneca Clinical Study Information Center
- Número de teléfono: 1-877-240-9479
- Correo electrónico: information.center@astrazeneca.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: up to 52 weeks
|
To describe changes in nasal polyp score (NPS) at each collected timepoint.
|
up to 52 weeks
|
|
Proportion of NPS responders
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to 52 weeks
|
To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.
|
Up to 52 weeks
|
|
Individual goal attainment
Periodo de tiempo: At Week 24 and Week 52
|
Proportion of participants achieving symptoms goal: SNOT-22* ≤ 20
|
At Week 24 and Week 52
|
|
Individual goal attainment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
31 de octubre de 2028
Finalización del estudio (Estimado)
28 de septiembre de 2029
Fechas de registro del estudio
Enviado por primera vez
18 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de agosto de 2026
Publicado por primera vez (Actual)
27 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D5242R00014
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir 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.
Criterios de acceso compartido de 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .