Tezepelumab CRSwNP Real World Study (CREW Study)
Chronic Rhinosinusitis With Nasal Polyps
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 100 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.)
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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 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.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
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
Tezepelumab DRUG
Subcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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 measures
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.
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.
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.
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).
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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).
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.
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).
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.
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.
Individual goal attainment
Time frame: At Week 24 and Week 52
Proportion of participants achieving symptoms goal: SNOT-22\* ≤ 20
Individual goal attainment
Time frame: At Week 24 and Week 52
Proportion of participants achieving Exacerbations goal: No SCS for sino-nasal exacerbations
Individual goal attainment
Time frame: At Week 24 and Week 52
Proportion of participants achieving Surgery goal: No sino-nasal surgery
Individual goal attainment
Time frame: At Week 24 and Week 52
Proportion of participants achieving Polyp burden goal: NPS improvement or NPS ≤2
Individual goal attainment
Time frame: At Week 24 and Week 52
Proportion of participants achieving olfaction goal: Smell PRO improvement following initiation of tezepelumab
Composite goal attainment
Time frame: At Week 24 and Week 52
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery
Composite goal attainment
Time frame: At Week 24 and Week 52
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/polyp
Composite goal attainment
Time frame: At Week 24 and Week 52
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/olfaction
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
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (16)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
16 locations
Research SiteChiba, JapanStatus unknown
Research SiteFukui, JapanStatus unknown
Research SiteFukuoka, JapanStatus unknown
Research SiteGunma, JapanStatus unknown
Research SiteHiroshima, JapanStatus unknown
Research SiteHokkaido, JapanStatus unknown
Research SiteHyōgo, JapanStatus unknown
Research SiteIshikawa, JapanStatus unknown
Research SiteKanagawa, JapanStatus unknown
Research SiteKyoto, JapanStatus unknown
Research SiteMiyagi, JapanStatus unknown
Research SiteOkayama, JapanStatus unknown
Research SiteOsaka, JapanStatus unknown
Research SiteTochigi, JapanStatus unknown
Research SiteTokushima, JapanStatus unknown
Research SiteTokyo, JapanStatus unknown
Study team and timeline
- Lead sponsor
- AstraZeneca
- Study start
- Nov 30, 2026 Estimated
- Primary completion
- Sep 30, 2028 Estimated
- Study completion
- Sep 30, 2028 Estimated
- First posted
- Aug 27, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
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.
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026