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

중증 천식이 있는 5~12세 어린이를 대상으로 위약과 비교하여 Tezepelumab의 유효성 및 안전성을 조사하기 위한 연구 (HORIZON)

2026년 10월 12일 업데이트: AstraZeneca

조절되지 않는 중증 천식을 앓고 있는 5~12세 어린이를 대상으로 한 다기관, 무작위, 이중 맹검, 병렬 그룹 위약 대조, 3상, Tezepelumab의 효능 및 안전성 연구(HORIZON)

To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This is a phase-3 multicentre, double-blind, parallel-group placebo-controlled, randomised study.

The study will comprise of:

  1. Screening/Run-in period of 4 to 6 weeks,
  2. 52-week double-blind Treatment period,
  3. Post-treatment Follow-up period of 12 weeks.

Participants will be randomised 2:1 to receive either tezepelumab or placebo administered by (SC) Subcutaneous injections for 52 weeks (double-blind Treatment period).

There will then be a 12-week off-treatment Follow-up period for participants who do not continue in the optional open-label Active Treatment Extension period.

An optional open-label Active Treatment Extension will allow all eligible participants the opportunity to receive active treatment with tezepelumab. The Active Treatment Extension period of the study will start following the 52-week double-blind Treatment period and will consist of a 104-week open-label Treatment period prior to the 12-week post-treatment Follow-up period.

연구 유형

중재적

등록 (추정된)

231

단계

  • 3단계

연락처 및 위치

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

연구 연락처

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      • Cincinnati, Ohio, 미국, 45229-3039
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      • Villarreal, 스페인, 12540
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  • 아르헨티나
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      • Buenos Aires, 아르헨티나, C1121ABE
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      • Buenos Aires, 아르헨티나, C1122
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      • CABA, 아르헨티나, C1028AAP
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      • Fukuoka, 일본, 813-0017
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  • 캐나다
    • Alberta
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    • Ontario
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      • Szigetvár, 헝가리, 7900
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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

5년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Written informed consent from (ICF) at least one parent/caregiver (as per local guidelines) and accompanying informed assent from the participant (where the participant is able to provide assent) prior to admission to the study.

  2. Participants must be 5 to < 12 years of age, at the time of signing the assent form (as applicable per local guidelines) and their caregivers signing the ICF and at Visit 3.

  3. Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1.

  4. Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1.

  5. Documented treatment with at least one additional maintenance asthma controller medication is required according to local guidelines and standard of care; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist) for at least 3 months with stable dose ≥ 1 month prior to Visit 1.

  6. Supportive evidence of asthma as documented by one of the following:

    1. Post-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol with a maximum of 12 puffs of reliever medication only if tolerated by the participant) at either Visit 1 or Visit 2.

      If (a) is not achieved at Visit 1 or Visit 2, historical documentation by any of the below prior to Visit 1:

    2. Post-BD responsiveness of FEV1 ≥ 10%.

    3. Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL.

    4. PEF average daily diurnal variability > 13% over a 2-week period.

    5. Variability of FEV1 ≥ 12% between any two clinical visits.

    6. Positive exercise challenge test (defined as a fall in FEV1 of > 12%).

    7. FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy.

  7. History of at least 2 severe asthma exacerbation events OR 1 severe asthma exacerbation event resulting in hospitalisation within 12 months prior to Visit 1.

  8. Pre-BD FEV1 >50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.85 at either Visit 1 or Visit 2.

  9. Evidence of uncontrolled asthma, with at least 1 of the below criteria:

    1. ACQ-IA score ≥ 1.5 at least once during Screening/Run-in, including Visit 3 (prior to Randomisation) for participants ≥ 6 years old at Screening.
    2. Use of reliever medication, other than as a preventive for exercise induced bronchospasm, on 3 or more days per week for at least 1 week during the Screening/Run-in period.
    3. Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period.
    4. Asthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in period.

  10. Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).

Exclusion Criteria:

  1. History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis.
  2. History of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
  3. History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or increase in the maintenance dose of oral corticosteroids within 30 days prior to Visit 1.
  4. Change in ICS dose within 1 month prior to Visit 1.
  5. History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation.

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Tezepelumab

Participants will be receiving tezepelumab subcutaneous injection
생물학적: Tezepelumab

Participants will be receiving subcutaneous injection of tezepelumab

다른 이름들:
  • MEDI9929 및 AMG157
위약 비교기: Placebo

Participants will be receiving placebo through a subcutaneous injection
다른: Placebo

Participants will be receiving subcutaneous injection of matching placebo

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Annualized severe asthma exacerbation rate (AAER)
기간: From Baseline to Week 52

To assess the effect of tezepelumab on severe asthma exacerbations in children 5 to < 12 years old with severe uncontrolled asthma compared with placebo.
From Baseline to Week 52

2차 결과 측정

결과 측정
측정값 설명
기간
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) percent predicted normal (PN)
기간: From Baseline to Week 52

To assess the effect of tezepelumab on pulmonary function (FEV1) in children with severe uncontrolled asthma compared with placebo. Pre-bronchodilator FEV1% PN will be determined by spirometry at the clinic visit.
From Baseline to Week 52
AAER associated with allergic asthma
기간: From Baseline to Week 52

AAER will be assessed in association with both allergic asthma (defined by a positive perennial allergen using serum specific IgE [FEIA]).
From Baseline to Week 52
Time to first severe asthma exacerbation
기간: From Baseline to Week 52

Time to first severe asthma exacerbation will be assessed.
From Baseline to Week 52
Proportion of participants with ≥ 1 severe asthma exacerbation
기간: From Baseline to Week 52

Proportion of participants with ≥ 1 severe asthma exacerbation will be assessed.
From Baseline to Week 52
AAER associated with ER visit or hospitalisation
기간: From Baseline to Week 52

AAER will be assessed in association with ER visits or hospitalisations.
From Baseline to Week 52
Cumulative exposure to systemic corticosteroids for treatment of severe asthma exacerbations
기간: From Baseline to Week 52

Cumulative exposure to systemic corticosteroids for treatment of severe asthma exacerbations over the 52 week double-blind treatment period
From Baseline to Week 52
Change from baseline in Paediatric Asthma Quality of Life Questionnaire (PAQLQ-(S)-IA) total score
기간: From Baseline to Week 52

Change from baseline of PAQLQ-(S)-IA total score will be assessed. The PAQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with asthma. The PAQLQ-(S)-IA has 23 questions in 3 domains (symptoms, activity limitation, and emotional function). Participants are asked to think about how they have been during the previous week and respond to each question on a 7-point scale (1 = extremely bothered to 7 = not bothered at all or 1 = all of the time to 7 = none of the time). There are 2 coloured cards (green and blue), which list sets of response options appropriate to different questions. The appropriate card should be used by the participant during completion of each question and then taken back when it is no longer required. The overall PAQLQ-(S)-IA score is the mean of all 23 responses, and the individual domain scores are the means of the items in those domains.
From Baseline to Week 52
Change from baseline in weekly mean daily Paediatric Asthma Symptom Observer (PASO) score
기간: From Baseline to Week 52

Change from baseline in PASO score will be assessed. The PASO questionnaire will be completed by the caregiver each day from the evening of Treatment period. Caregivers in this study will complete 4 items from the morning assessment capturing night-time asthma symptoms, rescue medication use, night-time awakenings, and maintenance asthma medication use. The evening assessment will capture daytime asthma symptoms, rescue medication use, activity limitation and change in asthma.
From Baseline to Week 52
Change from baseline in Asthma Control Questionnaire - Interviewer Administered (ACQ-IA) score
기간: From Baseline to Week 52

Change from baseline in ACQ-IA score will be assessed. The ACQ-IA will only be completed for participants ≥ 6 years old at Screening. The ACQ-IA is administered by trained individuals according to standardised instructions to help the child understand concepts like symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, and wheezing) and use of SABA during the past week using a 7-point scale. The ACQ-IA score is calculated by taking the mean of the 6 equally weighted items and ranges from 0 (well controlled) to 6 (extremely poorly controlled). The estimated minimal clinically important difference is 0.5
From Baseline to Week 52
Change from baseline in weekly mean rescue medication use
기간: From Baseline to Week 52

Change from baseline in weekly mean rescue medication use will be assessed.
From Baseline to Week 52
Change from baseline in weekly mean number of night-time awakenings
기간: From Baseline to Week 52

Change from baseline in weekly mean number of night-time awakenings will be assessed.
From Baseline to Week 52
Change from baseline in blood eosinophil count
기간: From Baseline to Week 52

Change from baseline in blood eosinophil count will be assessed.
From Baseline to Week 52
Change from baseline in fractional exhaled nitric oxide (FeNO)
기간: From Baseline to Week 52

Change from baseline in FeNO will be assessed.
From Baseline to Week 52
Change from baseline in total serum IgE
기간: From Baseline to Week 52

Change from baseline in total serum IgE will be assessed.
From Baseline to Week 52
Change from baseline in pre-bronchodilator (pre-BD) peak expiratory flow (PEF)
기간: From Baseline to Week 52

The effect of tezepelumab on pulmonary function compared with placebo will be assessed using spirometry.
From Baseline to Week 52
Number of asthma--related healthcare resource utilization (HRU)
기간: From Baseline to Week 52

Mean number and type of Asthma specific HRU (eg, unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) will be assessed.
From Baseline to Week 52
Number of participant/caregiver health-related absences
기간: From Baseline to Week 52

Mean number of participant/caregiver health-related absences from work/school due to asthma will be assessed.
From Baseline to Week 52
Serum concentrations of tezepelumab
기간: At Baseline, Week 4, Week 24, and Week 52

To evaluate the pharmacokinetics of tezepelumab.
At Baseline, Week 4, Week 24, and Week 52
Incidence of anti-drug antibodies (ADAs)
기간: At Baseline, and from time of first dose at Week 0 to end of study at week 64

To evaluate the immunogenicity of tezepelumab.
At Baseline, and from time of first dose at Week 0 to end of study at week 64
Incidence of neutralising antibodies (nAbs)
기간: At Baseline, and from time of first dose at Week 0 to end of study at week 64

To evaluate the immunogenicity of tezepelumab.
At Baseline, and from time of first dose at Week 0 to end of study at week 64

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

협력자

Amgen

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)

2023년 8월 24일

기본 완료 (추정된)

2028년 5월 31일

연구 완료 (추정된)

2030년 8월 23일

연구 등록 날짜

최초 제출

2023년 7월 20일

QC 기준을 충족하는 최초 제출

2023년 8월 30일

처음 게시됨 (실제)

2023년 9월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 12일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D5180C00016

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

예

미국 FDA 규제 기기 제품 연구

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. .

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