이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

테제펠루맙 치료를 시작하는 비용종증을 동반한 만성 비부비동염 성인 참가자의 증상 변화를 조사하기 위한 연구 (ESSENCE)

2026년 11월 2일 업데이트: AstraZeneca

Tezepelumab(ESSENCE) 치료를 시작하는 비용종증을 동반한 만성 비부비동염 성인 참가자의 증상 변화를 평가하기 위한 다기관, 단일군, 3b상 연구

The main objective of this study is to evaluate treatment outcomes of tezepelumab among participants with physician-determined surgery-eligible CRSwNP, with or without asthma.

Study details include:

  1. The study duration will be up to 40 weeks.
  2. The treatment duration will be up to 24 weeks.
  3. The visit frequency will be once every 4 weeks (Q4W).

연구 개요

상태

상태

현재 모집 상태 또는 확장 액세스 상태를 나타냅니다.
모집하지 않고 적극적으로

정황

정황

연구 중인 질병, 장애, 증후군, 질환 또는 부상입니다. ClinicalTrials.gov에서 조건에는 수명, 삶의 질 및 건강 위험과 같은 기타 건강 관련 문제도 포함될 수 있습니다.

개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.

상세 설명

This is a multicentre, open-label, single-arm, phase IIIb study is to describe changes from baseline in (1) participant-reported nasal congestion as evaluated by the nasal congestion score (NCS) and (2) participant-reported sino-nasal symptoms as evaluated by sino-nasal outcome test, 22 item (SNOT-22) following initiation of tezepelumab treatment.

Approximately 60 sites in 10 countries will enrol adult patients with physician determined surgery eligible CRSwNP.

The study is divided into 3 periods as described below:

  • Screening Period (from Week -4 until Week 0, up to 4 Weeks)
  • Treatment period (Week 0 to Week 24)
  • Safety Follow-up Period (Week 24 to Week 36)

연구 유형

연구 유형

임상 연구의 특성을 설명합니다. 연구 유형에는 중재 연구(임상 시험이라고도 함), 관찰 연구(환자 등록 포함) 및 확장된 액세스가 포함됩니다.
중재적

등록 (실제)

등록

임상 연구의 참가자 수. "예상" 등록은 연구원이 연구에 필요한 참가자의 목표 수입니다.
181

단계

단계

미국 식품의약국(FDA)에서 개발한 정의에 따라 약물 또는 생물학적 제품을 연구하는 임상 시험 단계입니다. 이 단계는 연구의 목적, 참가자 수 및 기타 특성을 기반으로 합니다. 초기 1단계(이전에는 0단계로 나열됨), 1단계, 2단계, 3단계 및 4단계의 5단계가 있습니다. 해당 없음은 장치 또는 행동 개입의 시험을 포함하여 FDA에서 정의한 단계가 없는 시험을 설명하는 데 사용됩니다.
  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 독일
      • Marburg, 독일, 35043
        • Research Site
      • Tübingen, 독일, 72076
        • Research Site
      • Villingen-Schwenningen, 독일, 78052
        • Research Site
      • Wiesbaden, 독일, 65183
        • Research Site
  • 미국
    • California
      • Newport Beach, California, 미국, 92663
        • Research Site
    • Illinois
      • Chicago, Illinois, 미국, 60611
        • Research Site
    • Massachusetts
      • Chestnut Hill, Massachusetts, 미국, 02467
        • Research Site
    • Missouri
      • Columbia, Missouri, 미국, 65201
        • Research Site
  • 불가리아
      • Plovdiv, 불가리아, 4003
        • Research Site
      • Sofia, 불가리아, 1431
        • Research Site
      • Sofia, 불가리아, 1606
        • Research Site
  • 스페인
      • Barcelona, 스페인, 08035
        • Research Site
      • Barcelona, 스페인, 08003
        • Research Site
      • Cadiz, 스페인, 11011
        • Research Site
      • Madrid, 스페인, 28041
        • Research Site
      • Salamanca, 스페인, 37007
        • Research Site
      • Santiago de Compostela, 스페인, 15706
        • Research Site
  • 이탈리아
      • Bologna, 이탈리아, 40139
        • Research Site
      • Catania, 이탈리아, 95123
        • Research Site
      • Florence, 이탈리아, 50139
        • Research Site
      • Padua, 이탈리아, 35128
        • Research Site
      • Pisa, 이탈리아, 56126
        • Research Site
      • Roma, 이탈리아, 00168
        • Research Site
      • Rozzano, 이탈리아, 20089
        • Research Site
  • 캐나다
    • Ontario
      • Hamilton, Ontario, 캐나다, L8S 1G5
        • Research Site
    • Quebec
      • Québec, Quebec, 캐나다, G1V 4W2
        • Research Site
      • Québec, Quebec, 캐나다, G1L 3L5
        • Research Site
  • 폴란드
      • Bialystok, 폴란드, 15-879
        • Research Site
      • Bydgoszcz, 폴란드, 85-231
        • Research Site
      • Lodz, 폴란드, 90-302
        • Research Site
      • Zawadzkie, 폴란드, 47-120
        • Research Site
  • 프랑스
      • Le Kremlin-Bicêtre, 프랑스, 94270
        • Research Site
      • Marseille, 프랑스, 13005
        • Research Site
      • Nantes, 프랑스, 44093
        • Research Site
      • Pierre-Bénite, 프랑스, 69495
        • Research Site
      • Poitiers, 프랑스, 86000
        • Research Site
      • Toulouse, 프랑스, 31400
        • Research Site
  • 헝가리
      • Budapest, 헝가리, 1085
        • Research Site
      • Budapest, 헝가리, 1134
        • Research Site
      • Nyíregyháza, 헝가리, 4400
        • Research Site
      • Pécs, 헝가리, 7621
        • Research Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

자격 기준

임상 연구에 참여하고자 하는 사람들이 충족해야 하는 주요 요구 사항 또는 그들이 가져야 할 특성. 자격 기준은 포함 기준(사람이 연구에 참여하는 데 필요함)과 제외 기준(사람이 참여하지 못하게 하는 것)으로 구성됩니다. 적격성 기준 유형에는 연구가 건강한 지원자를 받아들이는지, 연령 또는 연령 그룹 요구 사항이 있는지 또는 성별에 따라 제한되는지가 포함됩니다.

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Participants must be 18 years of age or older, at the time of signing the informed consent.
  • Participants with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 who have all of the following:
  • Severity consistent with the need for surgery as defined by total NPS ≥ 4 (at least 2 for each nostril) at screening, as determined by the central reader
  • Mean NCS ≥ 2 in the 2 weeks prior to Visit 2
  • Ongoing documented NP symptoms for > 8 weeks prior to screening such as rhinorrhoea, reduction or loss of smell and/or poor quality/loss of sleep
  • SNOT-22 total score ≥ 30 as assessed at screening. Note: approximately 50 participants with a NPS = 4 at screening will receive treatment with tezepelumab.
  • Any standard of care for treatment of CRSwNP, which must include treatment with intranasal corticosteroids, provided the participant is stable on that treatment for at least 30 days prior to Visit 1. Investigators should also assure that participants are compliant and on a stable dose of the background INCS during study period.
  • Either 1) documented treatment of NP exacerbation with SCS for at least 3 consecutive days or one IM depo-injectable dose (or contraindications/intolerance to) within the past 12 months prior to Visit 1 but not within the last 3 months prior to Visit 1 OR 2) any history of NP surgery (or contraindications/intolerance to)
  • Body weight of ≥ 40 kg at Visit 1
  • Female participants:
  • Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of non childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
  • Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned start date of the first IMP administration without an alternative medical cause.

The following age-specific requirements apply:

  • Women < 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels in the postmenopausal range.
  • Women ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.
  • WOCBP must be willing to use one of the methods of contraception described hereafter, from the time of signing the ICF throughout the study and 16 weeks after last tezepelumab administration:
  • Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
  • Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
  • Intrauterine device
  • Intrauterine hormone-releasing system
  • Bilateral tubal occlusion
  • Vasectomised partner (vasectomised partner is a highly effective birth control method provided that the partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success)
  • Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
  • Cessation of contraception after this point should be discussed with a responsible physician.
  • Provision of signed and dated written ICF as described in Appendix A 3 prior to any mandatory study-specific procedures, sampling, and analyses.
  • Participant who is capable of giving signed informed consent as described in Appendix A 3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria:

  • Participants with documented allergic fungal rhinosinusitis and/or central compartment atopic disease.

  • Any clinically important pulmonary disease other than asthma (eg, active lung infection, bronchiectasis, pulmonary fibrosis, cystic fibrosis, primary ciliary dyskinesia, allergic bronchopulmonary mycosis, hypereosinophilic syndromes, etc) that could confound interpretation of clinical CRSwNP endpoints results.

  • Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:

    • Affect the safety of the participant throughout the study
    • Influence the findings of the study or the interpretation
    • Impede the participant's ability to complete the entire duration of study.

  • Sinus surgery within 6 months of screening visit OR any sinus surgery in the past which changed the lateral wall of the nose making NPS evaluation impossible.

  • Participants with conditions or concomitant disease that makes them non-evaluable for the primary CRSwNP endpoints such as:

  • Antrochoanal polyps

  • Nasal septal deviation that occludes at least one nostril

  • Acute sinusitis, nasal infection, asthma exacerbation or upper respiratory infection at screening or in the two weeks before screening, or Churg-Strauss syndrome (also known as eosinophilic granulomatosis with polyangiitis), Young's syndrome or Kartagener's syndrome

  • History of cancer:

    1. Participants who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1.
    2. Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1.

  • Uncontrolled epistaxis within 2 months of Visit 1

  • A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.

  • For participants with comorbid asthma: Current smokers or participants with a smoking history ≥ 10 packs per year and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of < 10 pack per year and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.

  • History of chronic alcohol or drug abuse within 12 months prior to Visit 1.

  • Tuberculosis requiring treatment within the 12 months prior to Visit 1.

  • Major surgery within 8 weeks prior to Visit 1 or planned NP surgery or planned surgical procedures requiring general anaesthesia or inpatient status for more than 1 day during the conduct of the study.

  • History of known immunodeficiency disorder including a positive HIV test at Visit 1, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.

  • Infection requiring systemic antibiotics within 14 days prior to Visit 1. Note: Participants with respiratory infections requiring antibiotics within 14 days prior to Visit 1 may extend their screening period to allow recovery and return no sooner than 14 days after completion of therapy.

  • Evidence of COVID-19 within 4 weeks prior to screening or ongoing clinically significant COVID-19 sequelae (eg, participants who have long-term post-COVID-19 anosmia).

  • Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives (whichever is longest) prior to Visit 1.

  • Treatment with systemic immunosuppressive/immunomodulating drugs (eg, methotrexate, cyclosporine, etc.), except for SCS used in the treatment of asthma/asthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to Visit 1.

  • Receipt of immunoglobulin or blood products within 30 days prior to Visit 1.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔

참가자 그룹 / 팔

시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.
개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
실험적: Tezepelumab

Tezepelumab: Tezepelumab single dose subcutaneously injection.
조합 제품: Tezepelumab

IMP. Subcutaneous injection. Unit dose strengths 210 mg.

다른 이름들:
  • 테즈스파이어®

연구는 무엇을 측정합니까?

주요 결과 측정

주요 결과 측정

임상 연구 프로토콜에서 개입/치료의 효과를 평가하는 데 가장 중요한 계획된 결과 측정. 대부분의 임상 연구에는 하나의 주요 결과 측정이 있지만 일부는 둘 이상입니다.
결과 측정
측정값 설명
기간
Change from baseline in nasal congestion
기간: Week 24

Changes from baseline in participant-reported nasal congestion as evaluated by the nasal congestion score (NCS) as part of the nasal polyposis symptom diary (NPSD) following initiation of tezepelumab treatment.
Week 24
Change from baseline in sino-nasal symptoms
기간: Week 24

changes from baseline in participant reported sino nasal symptoms as evaluated by sino nasal outcome test, 22 item (SNOT 22) total score following initiation of tezepelumab treatment.
Week 24

2차 결과 측정

2차 결과 측정

임상 연구 프로토콜에서 개입의 효과를 평가하기 위한 1차 결과 측정만큼 중요하지는 않지만 여전히 관심이 있는 계획된 결과 측정입니다. 대부분의 임상 연구에는 하나 이상의 2차 결과 측정이 있습니다.
결과 측정
측정값 설명
기간
Proportion of NCS responders
기간: End of treatment - Week 24

Proportion of NCS responders (minimal clinically important difference [MCID] from baseline = 1.0) at each collected timepoint.
End of treatment - Week 24
Time to first response for NCS
기간: End of Treatment-week 24

Description of time to first response for NCS by analysing data at all collected timepoints.
End of Treatment-week 24
Change from baseline in NCS
기간: Daily for the 2 weeks prior to Week 0 through end of treatment visit (EOT; Week 24).

Change from baseline in NCS at each collected timepoint.
Daily for the 2 weeks prior to Week 0 through end of treatment visit (EOT; Week 24).
Proportion of SNOT-22 responders
기간: Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.

Proportion of SNOT-22 responders (MCID from baseline = -8.9) at each collected timepoint.
Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
Time to first response for SNOT-22
기간: Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.

Description of time to first response for SNOT-22 by analysing data at all collected timepoints.
Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
Change from baseline in SNOT-22
기간: Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.

Change from baseline in SNOT-22 at each collected timepoint.
Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
Change from baseline visit in nasal blockage (NB)
기간: Weeks 0, 4, 12, and 24.

Change from baseline visit in NB measured by PNIF
Weeks 0, 4, 12, and 24.
Change from baseline visit in NB
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, 24.

Change from baseline visit in NB measured by VAS-NB
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, 24.
Proportion of PNIF responders
기간: Weeks 0, 4, 12, and 24.

Proportion of PNIF responders (MCID from baseline =20 L/min).
Weeks 0, 4, 12, and 24.
Proportion of VAS-NB responders
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, 24.

Proportion of VAS-NB responders (MCID from baseline = -3.0) (in participants with VAS-NB ≥ 7 at baseline).
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, 24.
Time to first response for PNIF
기간: Weeks 0, 4, 12, and 24

Description of time to first response for PNIF by analysing data at all collected timepoints.
Weeks 0, 4, 12, and 24
First response for VAS NB
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, 24.

Description of time to first response for VAS NB by analysing data at all collected timepoints (in participants with VAS-NB ≥ 7 at baseline).
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, 24.
Change from baseline in loss of smell score evaluated by UPSIT or Sniffin Sticks
기간: Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24

Change from baseline in loss of smell score evaluated by UPSIT or Sniffin Sticks
Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
Change from baseline in loss of smell score evaluated by VAS-Taste
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24

Change from baseline in loss of smell score evaluated by VAS-Taste
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
Change from baseline in loss of smell score evaluated by VAS-Smell
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.

Change from baseline in loss of smell score evaluated by VAS-Smell
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
Proportion of UPSIT responders
기간: Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24.

Proportion of UPSIT responders (MCID from baseline = 4)
Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24.
Proportion of Sniffin sticks responders
기간: Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24

Proportion of Sniffin sticks responders (MCID from baseline = 6)
Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
Proportion of VAS-Smell responders
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24

Proportion of VAS-Smell responders (MCID from baseline = -3.0) (in participants with VAS-Smell ≥ 7 at baseline)
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
Proportion of participants with a reduction in VAS-Taste score from baseline
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.

Proportion of participants with a reduction in VAS-Taste score from baseline (in participants with VAS-Taste ≥ 7 at baseline)
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
Time to first response for UPSIT/Sniffin sticks
기간: Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24

Time to first response for UPSIT/Sniffin sticks by analysing data at all collected timepoints.
Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
Time to first response for VAS Smell
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24

Time to first response for VAS Smell by analysing data at all collected timepoints (in participants with VAS-Smell ≥ 7 at baseline).
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
Time to first improvement in VAS-Taste
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.

Time to first improvement in VAS-Taste by analysing data at all collected timepoints (in participants with VAS-Taste ≥ 7 at baseline).
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
Change from baseline in sleep as evaluated by PSQI total score
기간: Weeks 0, 12, and 24.

Change from baseline in sleep as evaluated by PSQI total score
Weeks 0, 12, and 24.
Change from baseline in sleep as evaluated by SNOT-22 Sleep domain score
기간: Screening, Week 0, Weeks 2, 4, 8, 12, 16, 20, and 24

Change from baseline in sleep as evaluated by SNOT-22 Sleep domain score
Screening, Week 0, Weeks 2, 4, 8, 12, 16, 20, and 24
Change from baseline in sleep as evaluated by VAS-Sleep
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24

Change from baseline in sleep as evaluated by VAS-Sleep
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
Proportion of PSQI responders
기간: Weeks 0, 12, and 24

Proportion of PSQI responders (MCID from baseline = - 4.4)
Weeks 0, 12, and 24
Proportion of SNOT-22 Sleep domain responders
기간: Screening, Week 0, Weeks 2, 4, 8, 12, 16, 20, and 24

Proportion of SNOT-22 Sleep domain responders (MCID from baseline = -2.9)
Screening, Week 0, Weeks 2, 4, 8, 12, 16, 20, and 24
Proportion of participants with any improvement in VAS Sleep from baseline
기간: Daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24

Proportion of participants with any improvement in VAS Sleep from baseline (in participants with VAS-Sleep ≥ 7 at baseline)
Daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
Time to first response for PSQI
기간: Weeks 0, 12, and 24.

Time to first response for PSQI by analysing data at all collected timepoints.
Weeks 0, 12, and 24.
Time to first response for SNOT-22 Sleep domain
기간: Screening, Week 0, Weeks 2, 4, 8, 12, 16, 20, and 24.

Time to first response for SNOT-22 Sleep domain by analysing data at all collected timepoints.
Screening, Week 0, Weeks 2, 4, 8, 12, 16, 20, and 24.
Time to first improvement for VAS-Sleep
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24

Time to first improvement for VAS-Sleep by analysing data at all collected timepoints (in participants with VAS-Sleep ≥ 7 at baseline).
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
Change from baseline in total NPS
기간: Screening, Weeks 2 and 24

Change from baseline in total NPS evaluated by nasal endoscopy.
Screening, Weeks 2 and 24
Proportion of NPS responders
기간: Screening, Weeks 2 and 24

Proportion of NPS responders (MCID from baseline = 1.0) at Weeks 2 and 24.
Screening, Weeks 2 and 24
Change from baseline in NPQ score
기간: Weeks 0, 8, 12, and 24.

Change from baseline in NPQ score
Weeks 0, 8, 12, and 24.
Proportion of NPQ responders
기간: Weeks 0, 8, 12, and 24

Proportion of NPQ responders (MCID from baseline = 7.0)
Weeks 0, 8, 12, and 24
Time to first response for NPQ
기간: Weeks 0, 8, 12, and 24.

Time to first response for NPQ by analysing data collected at each specified timepoint.
Weeks 0, 8, 12, and 24.
Change from baseline in TSS
기간: daily for the 2 weeks prior to Week 0 and through EOT (Week 24)

Change from baseline in TSS
daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
Proportion of TSS responders
기간: daily for the 2 weeks prior to Week 0 and through EOT (Week 24)

Proportion of TSS responders (MCID from baseline = 4.0)
daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
Time to first response for TSS
기간: daily for the 2 weeks prior to Week 0 and through EOT (Week 24)

Time to first response for TSS by analysing data at all collected timepoints.
daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
Change from baseline in NP severity
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.

Change from baseline in NP severity as measured by VAS Overall symptoms
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
Proportion of VAS Overall symptom responders
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.

Proportion of VAS Overall symptom responders (MCID from baseline = 2.5)
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
Time to first response for VAS-Overall symptom
기간: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.

Time to first response for VAS-Overall symptom by analysing data at all collected timepoints
daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question
기간: Weeks 0, 4, 8, 12, 20, and 24.

Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question
Weeks 0, 4, 8, 12, 20, and 24.
Time to first response for NP control
기간: Weeks 0, 4, 8, 12, 20, and 24.

Time to first response for NP control by analysing data at all collected timepoints.
Weeks 0, 4, 8, 12, 20, and 24.

기타 결과 측정

기타 결과 측정

임상 시험의 경우 참가자에 대한 개입/치료의 효과를 결정하는 데 사용되는 프로토콜에 설명된 계획된 측정입니다. 관찰 연구에서 질병이나 특성의 패턴 또는 노출, 위험 요인 또는 치료와의 연관성을 설명하는 데 사용되는 측정 또는 관찰입니다. 결과 측정 유형에는 1차 결과 측정과 2차 결과 측정이 포함됩니다.
결과 측정
측정값 설명
기간
Endoscopy findings will be used to describe histological changes and describe CRSwNP visualization
기간: Screening, Weeks 2 and 24

Endoscopy findings will be used to describe histological changes and describe CRSwNP visualization from baseline to Week 24.
Screening, Weeks 2 and 24
Change from baseline in blood eosinophil count (BEC), total serum IgE, specific IgE (including fungi/moulds [eg, Alternaria]), S. aureus enterotoxin IgE, and Fractional exhaled nitric oxide (FeNO; for asthma participants only)
기간: Screening (for BEC and FeNO), Week 0 (for IgE and S. aureus enterotoxin IgE), Weeks 12 and 24

Change from baseline in blood eosinophil count (BEC), total serum IgE, specific IgE (including fungi/moulds [eg, Alternaria]), S. aureus enterotoxin IgE, and Fractional exhaled nitric oxide (FeNO; for asthma participants only)
Screening (for BEC and FeNO), Week 0 (for IgE and S. aureus enterotoxin IgE), Weeks 12 and 24
Change from baseline in WPAI-CRSwNP
기간: Week 0 and Week 24

Change from baseline in WPAI-CRSwNP
Week 0 and Week 24
Proportion and annualised rate of primary care visits (all rates for CRSwNP-related and asthma-related).
기간: 24 weeks pre-and post index (index = 1st tezepelumab dosing).

Proportion and annualised rate of primary care visits (all rates for CRSwNP-related and asthma-related).
24 weeks pre-and post index (index = 1st tezepelumab dosing).
Change in incident rate of nasal infection comparing the post-index period versus the pre-index period
기간: 24 weeks pre- and post-index. (index = 1st tezepelumab dosing)

Change in incident rate of nasal infection comparing the post-index period versus the pre-index period (index = 1st tezepelumab dosing).
24 weeks pre- and post-index. (index = 1st tezepelumab dosing)
Change in proportion of participants with CRSwNP-related SCS use during the post-index period (24 weeks following tezepelumab first dose) versus the pre-treatment period (24 weeks prior to tezepelumab first dose)
기간: 24-weeks pre- and post- index. (index = 1st tezepelumab dosing).

Change in proportion of participants with CRSwNP-related SCS use during the post-index period (24 weeks following tezepelumab first dose) versus the pre-treatment period (24 weeks prior to tezepelumab first dose)
24-weeks pre- and post- index. (index = 1st tezepelumab dosing).
Change in average SCS daily dose during the post-index period versus dose at/closest to the index
기간: 24-weeks pre- and post- index. (index = 1st tezepelumab dosing).

Change in average SCS daily dose during the post-index period (24 weeks following tezepelumab first dose) versus dose at/closest to the index
24-weeks pre- and post- index. (index = 1st tezepelumab dosing).
Proportion of participants with the decision for CRSwNP surgery during the 24 weeks pre- and post-index and change in NP surgery proportion following tezepelumab initiation.
기간: 24-weeks pre- and post- index. (index = 1st tezepelumab dosing).

Proportion of participants with the decision for CRSwNP surgery during the 24 weeks pre- and post-index and change in NP surgery proportion following tezepelumab initiation.
24-weeks pre- and post- index. (index = 1st tezepelumab dosing).
Proportion of patients with CRSwNP exacerbation
기간: 24-weeks pre- and post-index (index = 1st tezepelumab dosing).

Proportion of patients with CRSwNP exacerbation
24-weeks pre- and post-index (index = 1st tezepelumab dosing).
Change since baseline in Asthma Control Questionnaire 6 (ACQ-6) score
기간: Weeks 0 and 24.

Change since baseline in Asthma Control Questionnaire 6 (ACQ-6) score
Weeks 0 and 24.
ACQ-6 responder: proportion of participants with change since baseline in ACQ-6 of 0.5 or above
기간: Weeks 0 and 24

ACQ-6 responder: proportion of participants with change since baseline in ACQ-6 of 0.5 or above
Weeks 0 and 24
Annualised asthma exacerbation rate
기간: 24 weeks pre-and post-index (index = 1st tezepelumab dosing).

Annualised asthma exacerbation rate
24 weeks pre-and post-index (index = 1st tezepelumab dosing).
Change from baseline in Annualised asthma exacerbation rate
기간: 24 weeks pre-and post-index (index = 1st tezepelumab dosing).

Change from baseline in Annualised asthma exacerbation rate
24 weeks pre-and post-index (index = 1st tezepelumab dosing).
Lung function (Forced expiratory volume in 1 second [FEV1]) (if available at site)
기간: Weeks 0, 12 (lung function only) and 24.

Lung function (Forced expiratory volume in 1 second [FEV1]) (if available at site)
Weeks 0, 12 (lung function only) and 24.
Asthma-related SCS use (yes/no)
기간: 24 weeks pre-and post-index (index = 1st tezepelumab dosing).

Asthma-related SCS use (yes/no)
24 weeks pre-and post-index (index = 1st tezepelumab dosing).
Proportion and annualised rate of urgent care (all rates for CRSwNP-related and asthma-related).
기간: 24 weeks pre-and post index (index=1st tezepelumab dosing)

Proportion and annualised rate of urgent care (all rates for CRSwNP-related and asthma-related).
24 weeks pre-and post index (index=1st tezepelumab dosing)
Proportion and annualised rate of unplanned surgery (all rates for CRSwNP-related and asthma-related).
기간: 24 weeks pre and post index (index=ist tezepelumab dosing)

Proportion and annualised rate of unplanned surgery (all rates for CRSwNP-related and asthma-related).
24 weeks pre and post index (index=ist tezepelumab dosing)
Proportion and annualised rate of unplanned out participant visits (all rates for CRSwNP-related and asthma-related).
기간: 24 weeks pre- and post index (index=1st tezepelumab dosing)

Proportion and annualised rate of unplanned out participant visits (all rates for CRSwNP-related and asthma-related).
24 weeks pre- and post index (index=1st tezepelumab dosing)
Proportion and annualised rate of emergency room visits (all rates for CRSwNP-related and asthma-related).
기간: 24 weeks pre-and post index (index=1st tezepelumab dosing)

Proportion and annualised rate of emergency room visits (all rates for CRSwNP-related and asthma-related).
24 weeks pre-and post index (index=1st tezepelumab dosing)
Proportion and annualised rate of hospitalisations (all rates for CRSwNP-related and asthma-related).
기간: 24 weeks pre-and post index(index=1st tezepelumab dosing)

Proportion and annualised rate of hospitalisations (all rates for CRSwNP-related and asthma-related).
24 weeks pre-and post index(index=1st tezepelumab dosing)
Asthma related SCS use as part of an exacerbation
기간: 24 weeks pre-and post index(index=1st tezepelumab dosing)

Asthma related SCS use as part of an exacerbation
24 weeks pre-and post index(index=1st tezepelumab dosing)
Asthma related SCS duration of use
기간: 24 weeks pre-and post index(index=1st tezepelumab dosing)

Asthma related SCS duration of use
24 weeks pre-and post index(index=1st tezepelumab dosing)
Asthma related SCS daily dose
기간: 24 weeks pre-and post index(index=1st tezepelumab dosing)

Asthma related SCS daily dose
24 weeks pre-and post index(index=1st tezepelumab dosing)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

스폰서

연구를 시작하고 연구에 대한 권한과 통제권을 가진 조직 또는 사람.
AstraZeneca

협력자

협력자

임상 연구를 지원하는 스폰서 이외의 조직. 이 지원에는 자금 조달, 설계, 구현, 데이터 분석 또는 보고와 관련된 활동이 포함될 수 있습니다.
Fortrea

수사관

수사관

임상 연구에 참여하는 연구원. 관련 용어에는 사이트 주임 조사관, 사이트 하위 조사자, 연구 의자, 연구 책임자 및 연구 주임 조사관이 포함됩니다.
  • 수석 연구원: Tanya M Laidlaw, MD, Director of Translational Research in Allergy and Director of the Aspirin-Exacerbated Respiratory Disease (AERD) Centre at the Brigham and Women's Hospital.
  • 수석 연구원: Enrico Heffler, MD, PhD, Associate Professor of Internal Medicine and Consultant at the Personalized Medicine, Asthma and Allergy Unit at IRCCS Humanitas Research Hospital

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 (실제)

연구 시작

첫 번째 참가자가 임상 연구에 등록된 실제 날짜입니다. "예상" 연구 시작 날짜는 연구자가 연구 시작 날짜가 될 것이라고 생각하는 날짜입니다.
2024년 12월 3일

기본 완료 (추정된)

기본 완료

임상 연구의 마지막 참가자가 1차 결과 측정을 위한 최종 데이터를 수집하기 위해 검사를 받거나 개입을 받은 날짜입니다. 임상 연구가 프로토콜에 따라 종료되었는지 또는 종료되었는지 여부는 이 날짜에 영향을 미치지 않습니다. 완료 날짜가 다른 1차 결과 측정이 둘 이상인 임상 연구의 경우 이 용어는 모든 1차 결과 측정에 대한 데이터 수집이 완료된 날짜를 나타냅니다. "예상" 기본 완료 날짜는 연구원이 연구의 기본 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2027년 1월 13일

연구 완료 (추정된)

연구 완료

임상 연구의 마지막 참가자가 1차 결과 측정, 2차 결과 측정 및 부작용(즉, 마지막 참가자의 마지막 방문)에 대한 최종 데이터를 수집하기 위해 검사를 받거나 중재/치료를 받은 날짜입니다. "예상" 연구 완료 날짜는 연구원이 연구 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2027년 1월 13일

연구 등록 날짜

최초 제출

최초 제출

연구 후원자 또는 연구자가 최초로 ClinicalTrials.gov에 연구 기록을 제출한 날짜. 일반적으로 처음 제출한 날짜와 ClinicalTrials.gov에서 기록을 사용할 수 있는 날짜(첫 게시 날짜) 사이에는 며칠의 지연이 있습니다.
2024년 11월 7일

QC 기준을 충족하는 최초 제출

QC 기준을 충족하는 최초 제출

연구 스폰서 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록을 처음 제출한 날짜입니다. 의뢰자 또는 조사자는 NLM의 QC 검토 기준이 충족되기 전에 연구 기록을 한 번 이상 수정하고 제출해야 할 수 있습니다. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2024년 11월 22일

처음 게시됨 (실제)

처음 게시됨

National Library of Medicine(NLM) 품질 관리(QC) 검토가 완료된 후 ClinicalTrials.gov에서 연구 기록을 처음 사용할 수 있는 날짜입니다. 일반적으로 연구 후원자 또는 연구자가 연구 기록을 제출한 날짜와 처음 게시된 날짜 사이에는 며칠의 지연이 있습니다.
2024년 11월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

마지막 업데이트 게시됨

ClinicalTrials.gov에서 연구 기록이 변경된 가장 최근 날짜. 연구 후원자 또는 연구자가 변경 사항을 ClinicalTrials.gov에 제출한 시점(마지막 업데이트 제출 날짜)과 마지막 업데이트 게시 날짜 사이에 지연이 있을 수 있습니다.
2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

QC 기준을 충족하는 마지막 업데이트 제출

연구 후원자 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록에 대한 변경 사항을 제출한 가장 최근 날짜. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2026년 11월 2일

마지막으로 확인됨

마지막으로 확인됨

연구 후원자 또는 조사자가 ClinicalTrials.gov에서 임상 연구에 대한 정보가 정확하고 최신 정보라고 확인한 가장 최근 날짜. 모집 상태가 모집인 연구인 경우; 아직 모집하지 않았습니다. 또는 활성, 비모집이 지난 2년 이내에 확인되지 않은 경우 연구의 모집 상태는 알 수 없음으로 표시됩니다.
2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

기타 연구 ID 번호

연구 후원자, 기금 제공자 또는 다른 사람이 임상 연구에 할당한 NCT 번호 이외의 식별자 또는 ID 번호. 이 번호에는 다른 시험 등록의 고유 식별자와 미국 국립보건원(National Institutes of Health) 보조금 번호가 포함될 수 있습니다.
  • D5242C00002

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 approved.

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 refer 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

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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. .

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