Tezepelumab CRSwNP Real World Study (CREW Study) (CREW)
24 août 2026 mis à jour par: 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.)
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Estimé)
100
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: AstraZeneca Clinical Study Information Center
- Numéro de téléphone: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: up to 52 weeks
|
To describe changes in nasal polyp score (NPS) at each collected timepoint.
|
up to 52 weeks
|
|
Proportion of NPS responders
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Up to 52 weeks
|
To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.
|
Up to 52 weeks
|
|
Individual goal attainment
Délai: At Week 24 and Week 52
|
Proportion of participants achieving symptoms goal: SNOT-22* ≤ 20
|
At Week 24 and Week 52
|
|
Individual goal attainment
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
31 octobre 2028
Achèvement de l'étude (Estimé)
28 septembre 2029
Dates d'inscription aux études
Première soumission
18 août 2026
Première soumission répondant aux critères de contrôle qualité
24 août 2026
Première publication (Réel)
27 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D5242R00014
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage 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.
Critères d'accès au partage 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .