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

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.)

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyps
• Intervention / Treatment: Drug: Tezepelumab

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Tezepelumab; Subcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care.; Other Names: Tezspire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score	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	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	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	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	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	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	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	To describe changes in sense of smell as evaluated by VAS-Smell	up to 52 weeks
Proportion of VAS-Smell responders	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	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	To describe changes in NP severity (VAS-NP) at each collected timepoint.	up to 52 weeks
Proportion of VAS-NP symptom responders	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	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	To describe changes in nasal polyp score (NPS) at each collected timepoint.	up to 52 weeks
Proportion of NPS responders	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	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	To describe responder proportion for NP control.	up to 52 weeks
Median time to first attainment of NP well control or NP complete control	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	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	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	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	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	To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.	Up to 52 weeks
Individual goal attainment	Proportion of participants achieving symptoms goal: SNOT-22* ≤ 20	At Week 24 and Week 52
Individual goal attainment	Proportion of participants achieving Exacerbations goal: No SCS for sino-nasal exacerbations	At Week 24 and Week 52
Individual goal attainment	Proportion of participants achieving Surgery goal: No sino-nasal surgery	At Week 24 and Week 52
Individual goal attainment	Proportion of participants achieving Polyp burden goal: NPS improvement or NPS ≤2	At Week 24 and Week 52
Individual goal attainment	Proportion of participants achieving olfaction goal: Smell PRO improvement following initiation of tezepelumab	At Week 24 and Week 52
Composite goal attainment	Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery	At Week 24 and Week 52
Composite goal attainment	Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/polyp	At Week 24 and Week 52
Composite goal attainment	Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/olfaction	At Week 24 and Week 52
Composite goal attainment	Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/polyp burden/olfaction	At Week 24 and Week 52

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): September 28, 2029

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: August 24, 2026
• First Posted (Actual): August 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Observational Study; Japan; Patient-Reported Outcomes; CRSwNP; Chronic rhinosinusitis with nasal polyps; Tezepelumab
• Additional Relevant MeSH Terms: tezepelumab
• Other Study ID Numbers: D5242R00014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: 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 Sharing Access Criteria

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No