Tezepelumab CRSwNP Real World Study (CREW Study)

NCT07790198 | Not Yet Recruiting

• 1 other identifier: D5242R00014
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.)

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Keywords

Tezepelumab; Chronic rhinosinusitis with nasal polyps; CRSwNP; Observational Study; Patient-Reported Outcomes; Japan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (32)

• Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score

  at 4, 12, and 52 weeks from initiation of tezepelumab treatment

• Proportion of tezepelumab SNOT-22 responders

  up to 52 weeks

• Odds to achieve tezepelumab SNOT-22 response

  up to 52 weeks

• Median time to first MCID-defined responder in sinonasal symptoms

  up to 52 weeks

• Mean change from baseline in nasal blockage (NB) measured by VAS-NB

  up to 52 weeks

Study Arms (1)

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

Interventions

Tezepelumab DRUG

Subcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care.

Also known as: Tezspire

Tezepelumab Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Interventions

tezepelumab

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): September 28, 2029
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.