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Un estudio para investigar la eficacia y seguridad de tezepelumab en comparación con placebo en niños de 5 a <12 años con asma grave (HORIZON)

12 de octubre de 2026 actualizado por: AstraZeneca

Un estudio de fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de eficacia y seguridad de tezepelumab en niños de 5 a <12 años con asma grave no controlada (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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

231

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

5 años a 11 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Tezepelumab

Participants will be receiving tezepelumab subcutaneous injection
Biológico: Tezepelumab

Participants will be receiving subcutaneous injection of tezepelumab

Otros nombres:
  • MEDI9929 y AMG157
Comparador de placebos: Placebo

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

Participants will be receiving subcutaneous injection of matching placebo

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Annualized severe asthma exacerbation rate (AAER)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) percent predicted normal (PN)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AstraZeneca

Colaboradores

Amgen

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de agosto de 2023

Finalización primaria (Estimado)

31 de mayo de 2028

Finalización del estudio (Estimado)

23 de agosto de 2030

Fechas de registro del estudio

Enviado por primera vez

20 de julio de 2023

Primero enviado que cumplió con los criterios de control de calidad

30 de agosto de 2023

Publicado por primera vez (Actual)

5 de septiembre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D5180C00016

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir 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.

Criterios de acceso compartido de 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 de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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