テゼペルマブによる治療を開始した鼻茸を伴う慢性副鼻腔炎の成人参加者の症状の変化を調査する研究 (ESSENCE)
テゼペルマブによる治療を開始した鼻茸を伴う慢性副鼻腔炎の成人参加者の症状の変化を評価する多施設共同単群第 3b 相試験 (ESSENCE)
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:
- The study duration will be up to 40 weeks.
- The treatment duration will be up to 24 weeks.
- The visit frequency will be once every 4 weeks (Q4W).
調査の概要
詳細な説明
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)
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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California
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Newport Beach、California、アメリカ、92663
- Research Site
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Illinois
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Chicago、Illinois、アメリカ、60611
- Research Site
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Massachusetts
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Chestnut Hill、Massachusetts、アメリカ、02467
- Research Site
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Missouri
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Columbia、Missouri、アメリカ、65201
- Research Site
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Bologna、イタリア、40139
- Research Site
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Catania、イタリア、95123
- Research Site
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Florence、イタリア、50139
- Research Site
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Padua、イタリア、35128
- Research Site
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Pisa、イタリア、56126
- Research Site
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Roma、イタリア、00168
- Research Site
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Rozzano、イタリア、20089
- Research Site
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Ontario
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Hamilton、Ontario、カナダ、L8S 1G5
- Research Site
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Quebec
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Québec、Quebec、カナダ、G1V 4W2
- Research Site
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Québec、Quebec、カナダ、G1L 3L5
- Research Site
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Barcelona、スペイン、08035
- Research Site
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Barcelona、スペイン、08003
- Research Site
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Cadiz、スペイン、11011
- Research Site
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Madrid、スペイン、28041
- Research Site
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Salamanca、スペイン、37007
- Research Site
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Santiago de Compostela、スペイン、15706
- Research Site
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Marburg、ドイツ、35043
- Research Site
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Tübingen、ドイツ、72076
- Research Site
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Villingen-Schwenningen、ドイツ、78052
- Research Site
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Wiesbaden、ドイツ、65183
- Research Site
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Budapest、ハンガリー、1085
- Research Site
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Budapest、ハンガリー、1134
- Research Site
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Nyíregyháza、ハンガリー、4400
- Research Site
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Pécs、ハンガリー、7621
- Research Site
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Le Kremlin-Bicêtre、フランス、94270
- Research Site
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Marseille、フランス、13005
- Research Site
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Nantes、フランス、44093
- Research Site
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Pierre-Bénite、フランス、69495
- Research Site
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Poitiers、フランス、86000
- Research Site
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Toulouse、フランス、31400
- Research Site
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Plovdiv、ブルガリア、4003
- Research Site
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Sofia、ブルガリア、1431
- Research Site
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Sofia、ブルガリア、1606
- Research Site
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Bialystok、ポーランド、15-879
- Research Site
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Bydgoszcz、ポーランド、85-231
- Research Site
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Lodz、ポーランド、90-302
- Research Site
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Zawadzkie、ポーランド、47-120
- Research Site
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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:
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Participants with documented allergic fungal rhinosinusitis and/or central compartment atopic disease.
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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.
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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.
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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.
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Participants with conditions or concomitant disease that makes them non-evaluable for the primary CRSwNP endpoints such as:
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Antrochoanal polyps
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Nasal septal deviation that occludes at least one nostril
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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
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History of cancer:
- 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.
- Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1.
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Uncontrolled epistaxis within 2 months of Visit 1
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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.
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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.
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History of chronic alcohol or drug abuse within 12 months prior to Visit 1.
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Tuberculosis requiring treatment within the 12 months prior to Visit 1.
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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.
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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.
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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.
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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).
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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.
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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.
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Receipt of immunoglobulin or blood products within 30 days prior to Visit 1.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Tezepelumab
Tezepelumab: Tezepelumab single dose subcutaneously injection. |
IMP. Subcutaneous injection. Unit dose strengths 210 mg.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline in nasal congestion
時間枠：Week 24
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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
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Change from baseline in sino-nasal symptoms
時間枠：Week 24
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of NCS responders
時間枠：End of treatment - Week 24
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Proportion of NCS responders (minimal clinically important difference [MCID] from baseline = 1.0) at each collected timepoint. |
End of treatment - Week 24
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Time to first response for NCS
時間枠：End of Treatment-week 24
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Description of time to first response for NCS by analysing data at all collected timepoints. |
End of Treatment-week 24
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Change from baseline in NCS
時間枠：Daily for the 2 weeks prior to Week 0 through end of treatment visit (EOT; Week 24).
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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).
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Proportion of SNOT-22 responders
時間枠：Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
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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.
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Time to first response for SNOT-22
時間枠：Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
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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.
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Change from baseline in SNOT-22
時間枠：Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
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Change from baseline in SNOT-22 at each collected timepoint. |
Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
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Change from baseline visit in nasal blockage (NB)
時間枠：Weeks 0, 4, 12, and 24.
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Change from baseline visit in NB measured by PNIF |
Weeks 0, 4, 12, and 24.
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Change from baseline visit in NB
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, 24.
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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.
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Proportion of PNIF responders
時間枠：Weeks 0, 4, 12, and 24.
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Proportion of PNIF responders (MCID from baseline =20 L/min). |
Weeks 0, 4, 12, and 24.
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Proportion of VAS-NB responders
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, 24.
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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.
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Time to first response for PNIF
時間枠：Weeks 0, 4, 12, and 24
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Description of time to first response for PNIF by analysing data at all collected timepoints. |
Weeks 0, 4, 12, and 24
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First response for VAS NB
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, 24.
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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.
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Change from baseline in loss of smell score evaluated by UPSIT or Sniffin Sticks
時間枠：Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
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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
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Change from baseline in loss of smell score evaluated by VAS-Taste
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
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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
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Change from baseline in loss of smell score evaluated by VAS-Smell
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
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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.
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Proportion of UPSIT responders
時間枠：Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24.
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Proportion of UPSIT responders (MCID from baseline = 4) |
Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24.
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Proportion of Sniffin sticks responders
時間枠：Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
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Proportion of Sniffin sticks responders (MCID from baseline = 6) |
Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
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Proportion of VAS-Smell responders
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
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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
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Proportion of participants with a reduction in VAS-Taste score from baseline
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
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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.
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Time to first response for UPSIT/Sniffin sticks
時間枠：Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
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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
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Time to first response for VAS Smell
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
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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
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Time to first improvement in VAS-Taste
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
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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.
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Change from baseline in sleep as evaluated by PSQI total score
時間枠：Weeks 0, 12, and 24.
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Change from baseline in sleep as evaluated by PSQI total score |
Weeks 0, 12, and 24.
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Change from baseline in sleep as evaluated by SNOT-22 Sleep domain score
時間枠：Screening, Week 0, Weeks 2, 4, 8, 12, 16, 20, and 24
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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
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Change from baseline in sleep as evaluated by VAS-Sleep
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
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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
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Proportion of PSQI responders
時間枠：Weeks 0, 12, and 24
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Proportion of PSQI responders (MCID from baseline = - 4.4) |
Weeks 0, 12, and 24
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Proportion of SNOT-22 Sleep domain responders
時間枠：Screening, Week 0, Weeks 2, 4, 8, 12, 16, 20, and 24
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Proportion of SNOT-22 Sleep domain responders (MCID from baseline = -2.9) |
Screening, Week 0, Weeks 2, 4, 8, 12, 16, 20, and 24
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Proportion of participants with any improvement in VAS Sleep from baseline
時間枠：Daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
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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
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Time to first response for PSQI
時間枠：Weeks 0, 12, and 24.
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Time to first response for PSQI by analysing data at all collected timepoints. |
Weeks 0, 12, and 24.
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Time to first response for SNOT-22 Sleep domain
時間枠：Screening, Week 0, Weeks 2, 4, 8, 12, 16, 20, and 24.
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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.
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Time to first improvement for VAS-Sleep
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
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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
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Change from baseline in total NPS
時間枠：Screening, Weeks 2 and 24
|
Change from baseline in total NPS evaluated by nasal endoscopy. |
Screening, Weeks 2 and 24
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Proportion of NPS responders
時間枠：Screening, Weeks 2 and 24
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Proportion of NPS responders (MCID from baseline = 1.0) at Weeks 2 and 24. |
Screening, Weeks 2 and 24
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Change from baseline in NPQ score
時間枠：Weeks 0, 8, 12, and 24.
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Change from baseline in NPQ score |
Weeks 0, 8, 12, and 24.
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Proportion of NPQ responders
時間枠：Weeks 0, 8, 12, and 24
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Proportion of NPQ responders (MCID from baseline = 7.0) |
Weeks 0, 8, 12, and 24
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Time to first response for NPQ
時間枠：Weeks 0, 8, 12, and 24.
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Time to first response for NPQ by analysing data collected at each specified timepoint. |
Weeks 0, 8, 12, and 24.
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Change from baseline in TSS
時間枠：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)
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Proportion of TSS responders
時間枠：daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
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Proportion of TSS responders (MCID from baseline = 4.0) |
daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
|
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Time to first response for TSS
時間枠：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)
|
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Change from baseline in NP severity
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
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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.
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Proportion of VAS Overall symptom responders
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
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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.
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Time to first response for VAS-Overall symptom
時間枠：daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
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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.
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Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question
時間枠：Weeks 0, 4, 8, 12, 20, and 24.
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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.
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Time to first response for NP control
時間枠：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.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Endoscopy findings will be used to describe histological changes and describe CRSwNP visualization
時間枠：Screening, Weeks 2 and 24
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Endoscopy findings will be used to describe histological changes and describe CRSwNP visualization from baseline to Week 24. |
Screening, Weeks 2 and 24
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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)
時間枠：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
時間枠：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).
時間枠：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
時間枠：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)
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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).
時間枠：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).
時間枠：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).
時間枠：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).
時間枠：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).
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：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.
- 主任研究者：Enrico Heffler, MD, PhD、Associate Professor of Internal Medicine and Consultant at the Personalized Medicine, Asthma and Allergy Unit at IRCCS Humanitas Research Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- D5242C00002
個々の参加者データ (IPD) の計画
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IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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