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Uno studio per indagare l'efficacia e la sicurezza di tezepelumab rispetto al placebo nei bambini di età compresa tra 5 e < 12 anni affetti da asma grave (HORIZON)

12 ottobre 2026 aggiornato da: AstraZeneca

Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, di fase 3, sull'efficacia e sulla sicurezza di tezepelumab in bambini di età compresa tra 5 e < 12 anni affetti da asma grave non controllato (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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

231

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Reclutamento
        • Research Site
      • Buenos Aires, Argentina, C1121ABE
        • Reclutamento
        • Research Site
      • Buenos Aires, Argentina, C1122
        • Reclutamento
        • Research Site
      • CABA, Argentina, C1028AAP
        • Terminato
        • Research Site
      • Florida, Argentina, B1602DQD
        • Reclutamento
        • Research Site
      • Lanus, Argentina, B1824KAJ
        • Reclutamento
        • Research Site
      • Lobos, Argentina, 7240
        • Reclutamento
        • Research Site
      • Mendoza, Argentina, M5500CCG
        • Reclutamento
        • Research Site
      • Quilmes, Argentina, B1878FNR
        • Terminato
        • Research Site
      • Rosario, Argentina, 2000
        • Reclutamento
        • Research Site
  • Brasile
      • Blumenau, Brasile, 89030-101
        • Reclutamento
        • Research Site
      • Curitiba, Brasile, 80060-240
        • Reclutamento
        • Research Site
      • Salvador, Brasile, 40060-330
        • Ritirato
        • Research Site
      • Sorocaba, Brasile, 18040-425
        • Reclutamento
        • Research Site
      • São Paulo, Brasile, 04024-002
        • Reclutamento
        • Research Site
      • São Paulo, Brasile, 05430-010
        • Reclutamento
        • Research Site
      • São Paulo, Brasile, 01227-200
        • Attivo, non reclutante
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C9
        • Reclutamento
        • Research Site
    • Ontario
      • Burlington, Ontario, Canada, L7L 6W6
        • Reclutamento
        • Research Site
      • Hamilton, Ontario, Canada, L8S 1G5
        • Reclutamento
        • Research Site
      • Windsor, Ontario, Canada, N8X 2G1
        • Reclutamento
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Reclutamento
        • Research Site
  • Cina
      • Beijing, Cina, 100191
        • Reclutamento
        • Research Site
      • Changchun, Cina, 130021
        • Reclutamento
        • Research Site
      • Hohhot, Cina, 010050
        • Reclutamento
        • Research Site
      • Lanzhou, Cina, 730000
        • Reclutamento
        • Research Site
      • Nanjing, Cina, 210008
        • Reclutamento
        • Research Site
      • Shanghai, Cina, 200127
        • Ritirato
        • Research Site
      • Shanghai, Cina, 200062
        • Reclutamento
        • Research Site
      • Shenyang, Cina, 110004
        • Reclutamento
        • Research Site
      • Shenzhen, Cina, 518026
        • Reclutamento
        • Research Site
      • Tianjin, Cina, 300201
        • Non ancora reclutamento
        • Research Site
      • Wuxi, Cina, 214023
        • Reclutamento
        • Research Site
      • Zhanjiang, Cina, 524001
        • Non ancora reclutamento
        • Research Site
      • Zhongshan, Cina, 528400
        • Non ancora reclutamento
        • Research Site
  • Colombia
      • Bogotá, Colombia, 110231
        • Ritirato
        • Research Site
      • Bogotá, Colombia
        • Ritirato
        • Research Site
      • Medellín, Colombia, 050034
        • Ritirato
        • Research Site
  • Corea del Sud
      • Seongnam-si, Corea del Sud, 13620
        • Reclutamento
        • Research Site
      • Seongnam-si, Corea del Sud, 13496
        • Ritirato
        • Research Site
      • Seoul, Corea del Sud, 03722
        • Reclutamento
        • Research Site
      • Seoul, Corea del Sud, 03181
        • Reclutamento
        • Research Site
  • Filippine
      • Iloilo City, Filippine, 5000
        • Reclutamento
        • Research Site
      • Las Piñas, Filippine, 1740
        • Reclutamento
        • Research Site
      • Quezon, Filippine, 1100
        • Reclutamento
        • Research Site
      • Santa Rosa, Filippine, 4026
        • Reclutamento
        • Research Site
  • Francia
      • Brest, Francia, 29609
        • Reclutamento
        • Research Site
      • Bron, Francia, 69500
        • Sospeso
        • Research Site
      • Créteil, Francia, 94010
        • Reclutamento
        • Research Site
      • Marseille, Francia, 13005
        • Reclutamento
        • Research Site
      • Paris, Francia, 75012
        • Reclutamento
        • Research Site
      • Paris, Francia, 75015
        • Reclutamento
        • Research Site
      • Paris, Francia, 75019
        • Reclutamento
        • Research Site
      • Rouen, Francia, 76031
        • Reclutamento
        • Research Site
      • Vandœuvre-lès-Nancy, Francia, 54511
        • Reclutamento
        • Research Site
  • Giappone
      • Fukuoka, Giappone, 811-1394
        • Reclutamento
        • Research Site
      • Fukuoka, Giappone, 813-0017
        • Reclutamento
        • Research Site
      • Fukuyama, Giappone, 720-8520
        • Reclutamento
        • Research Site
      • Funabashi-shi, Giappone, 273-8588
        • Reclutamento
        • Research Site
      • Nara, Giappone, 630-8581
        • Reclutamento
        • Research Site
      • Odawara, Giappone, 250-0055
        • Reclutamento
        • Research Site
      • Saga, Giappone, 840-8571
        • Reclutamento
        • Research Site
      • Shimotsuga-gun, Giappone, 321-0293
        • Reclutamento
        • Research Site
      • Yokohama, Giappone, 223-0059
        • Ritirato
        • Research Site
      • Ōtsu, Giappone, 520-0804
        • Reclutamento
        • Research Site
  • Italia
      • Genova, Italia, 16147
        • Reclutamento
        • Research Site
      • Pavia, Italia, 27100
        • Reclutamento
        • Research Site
      • Roma, Italia, 00165
        • Reclutamento
        • Research Site
  • Messico
      • Chihuahua City, Messico, 31000
        • Reclutamento
        • Research Site
      • Guadalajara, Messico, 44100
        • Reclutamento
        • Research Site
      • Mexico City, Messico, 06100
        • Non ancora reclutamento
        • Research Site
      • Veracruz, Messico, 91910
        • Reclutamento
        • Research Site
  • Olanda
      • Amsterdam, Olanda, 1105 AZ
        • Reclutamento
        • Research Site
      • Rotterdam, Olanda, 3015 GD
        • Reclutamento
        • Research Site
  • Polonia
      • Lodz, Polonia, 90-329
        • Reclutamento
        • Research Site
      • Tarnów, Polonia, 33-100
        • Reclutamento
        • Research Site
  • Regno Unito
      • Birmingham, Regno Unito, B4 6NH
        • Reclutamento
        • Research Site
      • Bradford, Regno Unito, BD9 6RJ
        • Reclutamento
        • Research Site
      • Bristol, Regno Unito, BS2 8BJ
        • Reclutamento
        • Research Site
      • Glasgow, Regno Unito, G3 8SJ
        • Ritirato
        • Research Site
      • Leicester, Regno Unito, LE1 5WW
        • Reclutamento
        • Research Site
      • London, Regno Unito, SE5 9RS
        • Reclutamento
        • Research Site
      • Nottingham, Regno Unito, NG7 2UH
        • Reclutamento
        • Research Site
      • Stoke-on-Trent, Regno Unito, ST4 6QG
        • Reclutamento
        • Research Site
  • Romania
      • Bucharest, Romania, 050159
        • Reclutamento
        • Research Site
      • Bucharest, Romania, 020395
        • Reclutamento
        • Research Site
  • Spagna
      • Badalona, Spagna, 08916
        • Reclutamento
        • Research Site
      • Barcelona, Spagna, 08035
        • Reclutamento
        • Research Site
      • Esplugues de Llobregat (Barc), Spagna, 08950
        • Reclutamento
        • Research Site
      • Madrid, Spagna, 28009
        • Reclutamento
        • Research Site
      • Sabadell, Spagna, 08208
        • Reclutamento
        • Research Site
      • Valencia, Spagna, 46010
        • Reclutamento
        • Research Site
      • Valencia, Spagna, 46026
        • Ritirato
        • Research Site
      • Villarreal, Spagna, 12540
        • Reclutamento
        • Research Site
  • Stati Uniti
    • Alabama
      • Montgomery, Alabama, Stati Uniti, 36106
        • Reclutamento
        • Research Site
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85016
        • Reclutamento
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72202
        • Ritirato
        • Research Site
    • California
      • La Jolla, California, Stati Uniti, 92037
        • Attivo, non reclutante
        • Research Site
      • Long Beach, California, Stati Uniti, 90806
        • Reclutamento
        • Research Site
      • Orange, California, Stati Uniti, 92868
        • Ritirato
        • Research Site
      • San Diego, California, Stati Uniti, 92123
        • Reclutamento
        • Research Site
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Reclutamento
        • Research Site
      • Savannah, Georgia, Stati Uniti, 31406
        • Terminato
        • Research Site
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21287
        • Reclutamento
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
        • Reclutamento
        • Research Site
      • Boston, Massachusetts, Stati Uniti, 02115
        • Reclutamento
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48105
        • Terminato
        • Research Site
      • Detroit, Michigan, Stati Uniti, 48201
        • Reclutamento
        • Research Site
    • New Jersey
      • Northfield, New Jersey, Stati Uniti, 08225
        • Reclutamento
        • Research Site
    • New York
      • Hawthorne, New York, Stati Uniti, 10532
        • Reclutamento
        • Research Site
      • Schenectady, New York, Stati Uniti, 12304
        • Ritirato
        • Research Site
      • Staten Island, New York, Stati Uniti, 10305
        • Reclutamento
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27514
        • Reclutamento
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45229-3039
        • Reclutamento
        • Research Site
      • Cleveland, Ohio, Stati Uniti, 44106
        • Reclutamento
        • Research Site
      • Toledo, Ohio, Stati Uniti, 43617
        • Reclutamento
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73120
        • Reclutamento
        • Research Site
    • South Carolina
      • Columbia, South Carolina, Stati Uniti, 29203
        • Ritirato
        • Research Site
    • Texas
      • Coppell, Texas, Stati Uniti, 75019
        • Terminato
        • Research Site
      • Dallas, Texas, Stati Uniti, 75246
        • Reclutamento
        • Research Site
      • Frisco, Texas, Stati Uniti, 75034
        • Ritirato
        • Research Site
      • Houston, Texas, Stati Uniti, 77030
        • Reclutamento
        • Research Site
      • San Antonio, Texas, Stati Uniti, 78249
        • Reclutamento
        • Research Site
      • Temple, Texas, Stati Uniti, 76508
        • Ritirato
        • Research Site
  • Sud Africa
      • Bellville, Sud Africa, 7531
        • Reclutamento
        • Research Site
      • Cape Town, Sud Africa, 7925
        • Reclutamento
        • Research Site
      • Durban, Sud Africa, 4001
        • Reclutamento
        • Research Site
      • Durban, Sud Africa, 3630
        • Attivo, non reclutante
        • Research Site
      • Middelburg, Sud Africa, 1055
        • Reclutamento
        • Research Site
      • Thabazimbi, Sud Africa, 0380
        • Ritirato
        • Research Site
      • Vereeniging, Sud Africa, 1935
        • Reclutamento
        • Research Site
      • Welkom, Sud Africa, 9460
        • Reclutamento
        • Research Site
  • Tailandia
      • Bangkok, Tailandia, 10330
        • Reclutamento
        • Research Site
      • Bangkoknoi, Tailandia, 10700
        • Reclutamento
        • Research Site
      • Chiang Mai, Tailandia, 50200
        • Reclutamento
        • Research Site
      • Muang, Tailandia, 40002
        • Reclutamento
        • Research Site
  • Turchia (Türkiye)
      • Bursa, Turchia (Türkiye), 16059
        • Reclutamento
        • Research Site
      • Istanbul, Turchia (Türkiye), 34899
        • Reclutamento
        • Research Site
      • Izmir, Turchia (Türkiye), 35210
        • Reclutamento
        • Research Site
      • Yenimahalle, Turchia (Türkiye), 06500
        • Reclutamento
        • Research Site
  • Ucraina
      • Chernivtsi, Ucraina, 58002
        • Reclutamento
        • Research Site
      • Ivano-Frankivsk, Ucraina, 76000
        • Reclutamento
        • Research Site
      • Kyiv, Ucraina, 04050
        • Reclutamento
        • Research Site
      • Kyiv, Ucraina, 03038
        • Reclutamento
        • Research Site
  • Ungheria
      • Debrecen, Ungheria, 4031
        • Completato
        • Research Site
      • Szeged, Ungheria, 6720
        • Reclutamento
        • Research Site
      • Szigetvár, Ungheria, 7900
        • Reclutamento
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 5 anni a 11 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Tezepelumab

Participants will be receiving tezepelumab subcutaneous injection
Biologico: Tezepelumab

Participants will be receiving subcutaneous injection of tezepelumab

Altri nomi:
  • MEDI9929 e AMG157
Comparatore placebo: Placebo

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

Participants will be receiving subcutaneous injection of matching placebo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Annualized severe asthma exacerbation rate (AAER)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) percent predicted normal (PN)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Collaboratori

Amgen

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 agosto 2023

Completamento primario (Stimato)

31 maggio 2028

Completamento dello studio (Stimato)

23 agosto 2030

Date di iscrizione allo studio

Primo inviato

20 luglio 2023

Primo inviato che soddisfa i criteri di controllo qualità

30 agosto 2023

Primo Inserito (Effettivo)

5 settembre 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D5180C00016

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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