Tezepelumab CRSwNP Real World Study (CREW Study) (CREW)
2026년 8월 24일 업데이트: 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.)
연구 개요
연구 유형
관찰
등록 (추정된)
100
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: AstraZeneca Clinical Study Information Center
- 전화번호: 1-877-240-9479
- 이메일: information.center@astrazeneca.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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Subcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
기간: at 24 weeks from initiation of tezepelumab treatment.
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To describe the changes in participant-reported sinonasal symptoms as evaluated by sinonasal outcome test, 22 item (SNOT-22) total score.
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at 24 weeks from initiation of tezepelumab treatment.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
기간: at 4, 12, and 52 weeks from initiation of tezepelumab treatment
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To describe the changes in participant-reported sinonasal symptoms as SNOT-22 total score following initiation of tezepelumab treatment.
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at 4, 12, and 52 weeks from initiation of tezepelumab treatment
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Proportion of tezepelumab SNOT-22 responders
기간: 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.
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up to 52 weeks
|
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Odds to achieve tezepelumab SNOT-22 response
기간: up to 52 weeks
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Odds to achieve tezepelumab SNOT-22 response meeting or exceeding the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint.
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up to 52 weeks
|
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Median time to first MCID-defined responder in sinonasal symptoms
기간: 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).
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up to 52 weeks
|
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Mean change from baseline in nasal blockage (NB) measured by VAS-NB
기간: up to 52 weeks
|
To describe changes in nasal blockage (NB) as evaluated by a visual analogue scale (VAS-NB) at each collected timepoint.
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up to 52 weeks
|
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Proportion of NB responders
기간: 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.
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up to 52 weeks
|
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Median time to meeting or exceeding the MCID for VAS-NB
기간: 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.
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up to 52 weeks
|
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Mean change from baseline in sense of smell score by VAS-smell
기간: up to 52 weeks
|
To describe changes in sense of smell as evaluated by VAS-Smell
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up to 52 weeks
|
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Proportion of VAS-Smell responders
기간: 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.
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up to 52 weeks
|
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Median time to meeting or exceeding the MCID for VAS-Smell
기간: 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.
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up to 52 weeks
|
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Mean change from baseline in NP severity as measured by VAS-NP symptoms
기간: up to 52 weeks
|
To describe changes in NP severity (VAS-NP) at each collected timepoint.
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up to 52 weeks
|
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Proportion of VAS-NP symptom responders
기간: up to 52 weeks
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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.
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up to 52 weeks
|
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Median time to meeting or exceeding the MCID for VAS-NP symptom
기간: up to 52 weeks
|
Median time from baseline to the first occurrence of a ≥2.5-point decrease by each collected timepoint.
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up to 52 weeks
|
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Mean change from baseline in total NPS evaluated by nasal endoscopy
기간: up to 52 weeks
|
To describe changes in nasal polyp score (NPS) at each collected timepoint.
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up to 52 weeks
|
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Proportion of NPS responders
기간: up to 52 weeks
|
To describe proportion of NPS responders, defined as patients achieving the MCID (≥ 1.0-point decrease from baseline).
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up to 52 weeks
|
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Median time to meeting or exceeding the MCID for NPS
기간: up to 52 weeks
|
To describe median time to meeting or exceeding the MCID for NPS by each collected timepoint.
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up to 52 weeks
|
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Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question
기간: up to 52 weeks
|
To describe responder proportion for NP control.
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up to 52 weeks
|
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Median time to first attainment of NP well control or NP complete control
기간: up to 52 weeks
|
To describe median time to first attainment of NP well control or NP complete control by each collected timepoint.
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up to 52 weeks
|
|
Average SCS daily dose after initiating tezepelumab
기간: 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).
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From baseline up to 24 weeks and from baseline up to 52 weeks
|
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Proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use
기간: From baseline up to 24 weeks and from baseline up to 52 weeks
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To describe proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use.
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From baseline up to 24 weeks and from baseline up to 52 weeks
|
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Number of patients with ≥ 100, 200 and 400 mg cumulative SCS
기간: From baseline up to 24 weeks and from baseline up to 52 weeks
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Number of patients with ≥ 100, 200 and 400 mg cumulative SCS (e.g., prednisone-equivalent milligrams).
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From baseline up to 24 weeks and from baseline up to 52 weeks
|
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Time-to-first disease-related SCS use
기간: 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.
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From baseline up to 24 weeks and from baseline up to 52 weeks
|
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Proportion of participants with AEs, SAEs, DAEs, and AESIs
기간: Up to 52 weeks
|
To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.
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Up to 52 weeks
|
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Individual goal attainment
기간: At Week 24 and Week 52
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Proportion of participants achieving symptoms goal: SNOT-22* ≤ 20
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At Week 24 and Week 52
|
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Individual goal attainment
기간: At Week 24 and Week 52
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Proportion of participants achieving Exacerbations goal: No SCS for sino-nasal exacerbations
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At Week 24 and Week 52
|
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Individual goal attainment
기간: At Week 24 and Week 52
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Proportion of participants achieving Surgery goal: No sino-nasal surgery
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At Week 24 and Week 52
|
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Individual goal attainment
기간: At Week 24 and Week 52
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Proportion of participants achieving Polyp burden goal: NPS improvement or NPS ≤2
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At Week 24 and Week 52
|
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Individual goal attainment
기간: At Week 24 and Week 52
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Proportion of participants achieving olfaction goal: Smell PRO improvement following initiation of tezepelumab
|
At Week 24 and Week 52
|
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Composite goal attainment
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2028년 10월 31일
연구 완료 (추정된)
2029년 9월 28일
연구 등록 날짜
최초 제출
2026년 8월 18일
QC 기준을 충족하는 최초 제출
2026년 8월 24일
처음 게시됨 (실제)
2026년 8월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 24일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- D5242R00014
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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.
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .