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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06023589
Other study ID # D5180C00016
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 24, 2023
Est. completion date December 31, 2027

Study information

Verified date June 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 24-week open-label Treatment period prior to the 12-week post-treatment Follow-up period.


Recruitment information / eligibility

Status Recruiting
Enrollment 372
Est. completion date December 31, 2027
Est. primary completion date April 23, 2027
Accepts healthy volunteers No
Gender All
Age group 5 Years to 11 Years
Eligibility 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 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. Evidence of asthma as documented by one of the following: 1. Documented historical BD responsiveness of FEV1 = 10% in the previous 12 months prior to Visit 1 OR 2. Documented historical methacholine challenge result of = 16 mg/mL in the previous 12 months prior to Visit 1 OR 3. Post-BD (albuterol/salbutamol) responsiveness of FEV1 = 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol) at either Visit 1 or Visit 2. 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 FEV-1 >50% and = 95%PN OR FEV1/forced vital capacity (FVC) ratio = 0.8 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 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 or mechanical ventilation.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Tezepelumab
Participants will be receiving subcutaneous injection of tezepelumab
Other:
Placebo
Participants will be receiving subcutaneous injection of matching placebo

Locations

Country Name City State
Argentina Research Site Buenos Aires
Argentina Research Site Caba
Argentina Research Site Caba
Argentina Research Site Capital Federal
Argentina Research Site Florida
Argentina Research Site Lanus Este
Argentina Research Site Lobos
Argentina Research Site Mendoza
Argentina Research Site Quilmes
Argentina Research Site Rosario
Brazil Research Site Blumenau
Brazil Research Site Curitiba
Brazil Research Site Sao Paulo
Brazil Research Site Sao Paulo
Brazil Research Site São Paulo
Brazil Research Site Sorocaba
Canada Research Site Burlington Ontario
Canada Research Site Edmonton Alberta
Canada Research Site Hamilton Ontario
Canada Research Site Montreal Quebec
Canada Research Site Windsor Ontario
China Research Site Beijing
China Research Site Changchun
China Research Site Lanzhou
China Research Site Nanjing
China Research Site Shanghai
China Research Site Shanghai
China Research Site Shenyang
China Research Site Wuxi
Colombia Research Site Bogota
Colombia Research Site Bogotá
Colombia Research Site Medellín
France Research Site Brest
France Research Site Bron
France Research Site Creteil
France Research Site Paris
France Research Site Paris
France Research Site Vandoeuvre les Nancy Cedex
Hungary Research Site Debrecen
Hungary Research Site Szeged
Hungary Research Site Szigetvár
Japan Research Site Fukuoka-shi
Japan Research Site Funabashi-shi
Japan Research Site Odawara
Japan Research Site Saga-shi
Japan Research Site Shimotsuga-gun
Japan Research Site Yokohama-shi
Korea, Republic of Research Site SeongNam
Korea, Republic of Research Site Seongnam-Si
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Mexico Research Site Chihuahua
Mexico Research Site Guadalajara
Mexico Research Site Veracruz
Netherlands Research Site Amsterdam
Netherlands Research Site Rotterdam
Philippines Research Site Iloilo
Philippines Research Site Las Piñas
Philippines Research Site Quezon City
Philippines Research Site Santa Rosa
Poland Research Site Lódz
Poland Research Site Tarnow
Poland Research Site Tarnów
South Africa Research Site Bellville
South Africa Research Site Cape Town
South Africa Research Site Durban
South Africa Research Site Durban
Spain Research Site Barcelona
Spain Research Site Barcelona
Spain Research Site Esplugues De Llobregat (Barc)
Spain Research Site Madrid
Spain Research Site Valencia
Spain Research Site Villarreal (Castellón)
United Kingdom Research Site Birmingham
United Kingdom Research Site Bradford
United Kingdom Research Site Bristol
United Kingdom Research Site Glasgow
United Kingdom Research Site Leicester
United Kingdom Research Site London
United Kingdom Research Site Nottingham
United States Research Site Ann Arbor Michigan
United States Research Site Atlanta Georgia
United States Research Site Boston Massachusetts
United States Research Site Chapel Hill North Carolina
United States Research Site Cincinnati Ohio
United States Research Site Cleveland Ohio
United States Research Site Coppell Texas
United States Research Site Dallas Texas
United States Research Site Detroit Michigan
United States Research Site Little Rock Arkansas
United States Research Site Montgomery Alabama
United States Research Site Oklahoma City Oklahoma
United States Research Site Orange California
United States Research Site Phoenix Arizona
United States Research Site San Diego California
United States Research Site Savannah Georgia
United States Research Site Schenectady New York
United States Research Site Staten Island New York
United States Research Site Temple Texas
United States Research Site Toledo Ohio

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  China,  Colombia,  France,  Hungary,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Philippines,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Annualized asthma exacerbation rate (AAER) 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
Secondary Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) percent predicted normal (PN) 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
Secondary AAER associated with allergic asthma 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
Secondary Time to first severe asthma exacerbation Time to first severe asthma exacerbation will be assessed. From Baseline to Week 52
Secondary Proportion of participants with = 1 severe asthma exacerbation Proportion of participants with = 1 severe asthma exacerbation will be assessed. From Baseline to Week 52
Secondary AAER associated with ER visit or hospitalisation AAER will be assessed in association with ER visits or hospitalisations. From Baseline to Week 52
Secondary Cumulative asthma exacerbation days The cumulative asthma exacerbation days from baseline to week 52 will be assessed From Baseline to Week 52
Secondary Change from baseline in Paediatric Asthma Quality of Life Questionnaire (PAQLQ-IA) total score Change from baseline of PAQLQ-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-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-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
Secondary Change from baseline in weekly mean daily Paediatric Asthma Symptom Observer (PASO) score 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
Secondary Change from baseline in Asthma Control Questionnaire - Interviewer Administered (ACQ-IA) score 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
Secondary Change from baseline in weekly mean rescue medication use Change from baseline in weekly mean rescue medication use will be assessed. From Baseline to Week 52
Secondary Change from baseline in weekly mean number of night-time awakenings Change from baseline in weekly mean number of night-time awakenings will be assessed. From Baseline to Week 52
Secondary Change from baseline in blood eosinophil count Change from baseline in blood eosinophil count will be assessed. From Baseline to Week 52
Secondary Change from baseline in fractional exhaled nitric oxide (FeNO) Change from baseline in FeNO will be assessed. From Baseline to Week 52
Secondary Change from baseline in total serum IgE Change from baseline in total serum IgE will be assessed. From Baseline to Week 52
Secondary Change from baseline in pre-bronchodilator (pre-BD) peak expiratory flow (PEF) The effect of tezepelumab on pulmonary function compared with placebo will be assessed using spirometry. From Baseline to Week 52
Secondary Number of asthma--related healthcare resource utilization (HRU) 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
Secondary Number of participant/caregiver health-related absences Mean number of participant/caregiver health-related absences from work/school due to asthma will be assessed. From Baseline to Week 52
Secondary Serum concentrations of tezepelumab To evaluate the pharmacokinetics of tezepelumab. At Baseline, Week 4, Week 24, and Week 52
Secondary Incidence of anti-drug antibodies (ADAs) To evaluate the immunogenicity of tezepelumab. At Baseline, and from time of first dose at Week 0 to end of study at week 64
Secondary Incidence of neutralising antibodies (nAbs) To evaluate the immunogenicity of tezepelumab. At Baseline, and from time of first dose at Week 0 to end of study at week 64
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