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NCT Number: NCT07790198

Tezepelumab CRSwNP Real World Study (CREW Study)

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.)

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tezepelumab

Drug

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

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

  2. Proportion of tezepelumab SNOT-22 responders

    Time frame: 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.

  3. Odds to achieve tezepelumab SNOT-22 response

    Time frame: 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.

  4. Median time to first MCID-defined responder in sinonasal symptoms

    Time frame: 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).

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

    Time frame: up to 52 weeks

    To describe changes in nasal blockage (NB) as evaluated by a visual analogue scale (VAS-NB) at each collected timepoint.

  6. Proportion of NB responders

    Time frame: 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.

  7. Median time to meeting or exceeding the MCID for VAS-NB

    Time frame: 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.

  8. Mean change from baseline in sense of smell score by VAS-smell

    Time frame: up to 52 weeks

    To describe changes in sense of smell as evaluated by VAS-Smell

  9. Proportion of VAS-Smell responders

    Time frame: 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.

  10. Median time to meeting or exceeding the MCID for VAS-Smell

    Time frame: 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.

  11. Mean change from baseline in NP severity as measured by VAS-NP symptoms

    Time frame: up to 52 weeks

    To describe changes in NP severity (VAS-NP) at each collected timepoint.

  12. Proportion of VAS-NP symptom responders

    Time frame: 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.

  13. Median time to meeting or exceeding the MCID for VAS-NP symptom

    Time frame: up to 52 weeks

    Median time from baseline to the first occurrence of a ≥2.5-point decrease by each collected timepoint.

  14. Mean change from baseline in total NPS evaluated by nasal endoscopy

    Time frame: up to 52 weeks

    To describe changes in nasal polyp score (NPS) at each collected timepoint.

  15. Proportion of NPS responders

    Time frame: up to 52 weeks

    To describe proportion of NPS responders, defined as patients achieving the MCID (≥ 1.0-point decrease from baseline).

  16. Median time to meeting or exceeding the MCID for NPS

    Time frame: up to 52 weeks

    To describe median time to meeting or exceeding the MCID for NPS by each collected timepoint.

  17. Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question

    Time frame: up to 52 weeks

    To describe responder proportion for NP control.

  18. Median time to first attainment of NP well control or NP complete control

    Time frame: up to 52 weeks

    To describe median time to first attainment of NP well control or NP complete control by each collected timepoint.

  19. Average SCS daily dose after initiating tezepelumab

    Time frame: 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).

  20. Proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use

    Time frame: 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.

  21. Number of patients with ≥ 100, 200 and 400 mg cumulative SCS

    Time frame: 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).

  22. Time-to-first disease-related SCS use

    Time frame: 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.

  23. Proportion of participants with AEs, SAEs, DAEs, and AESIs

    Time frame: Up to 52 weeks

    To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.

  24. Individual goal attainment

    Time frame: At Week 24 and Week 52

    Proportion of participants achieving symptoms goal: SNOT-22* ≤ 20

  25. Individual goal attainment

    Time frame: At Week 24 and Week 52

    Proportion of participants achieving Exacerbations goal: No SCS for sino-nasal exacerbations

  26. Individual goal attainment

    Time frame: At Week 24 and Week 52

    Proportion of participants achieving Surgery goal: No sino-nasal surgery

  27. Individual goal attainment

    Time frame: At Week 24 and Week 52

    Proportion of participants achieving Polyp burden goal: NPS improvement or NPS ≤2

  28. Individual goal attainment

    Time frame: At Week 24 and Week 52

    Proportion of participants achieving olfaction goal: Smell PRO improvement following initiation of tezepelumab

  29. Composite goal attainment

    Time frame: At Week 24 and Week 52

    Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery

  30. Composite goal attainment

    Time frame: At Week 24 and Week 52

    Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/polyp

  31. Composite goal attainment

    Time frame: At Week 24 and Week 52

    Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/olfaction

  32. Composite goal attainment

    Time frame: At Week 24 and Week 52

    Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/polyp burden/olfaction

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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.

Acronym: CREW

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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