Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02948959
Registration number
NCT02948959
Ethics application status
Date submitted
27/10/2016
Date registered
31/10/2016
Date last updated
28/03/2022
Titles & IDs
Public title
Evaluation of Dupilumab in Children With Uncontrolled Asthma
Query!
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Children 6 to <12 Years of Age With Uncontrolled Persistent Asthma
Query!
Secondary ID [1]
0
0
2016-001607-23
Query!
Secondary ID [2]
0
0
EFC14153
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
VOYAGE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Asthma
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Asthma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab
Treatment: Drugs - Placebo
Treatment: Drugs - Asthma Controller Therapies
Treatment: Drugs - Asthma Reliever Therapies
Placebo Comparator: Placebo - Placebo (for Dupilumab), subcutaneous (SC) injection every 2 weeks (q2w) for 52 weeks in combination with stable-dose background therapy of medium-dose inhaled corticosteroids (ICS) with a second controller medication (i.e., long-acting ß2 agonist [LABA], long acting muscarinic antagonist [LAMA], leukotriene receptor antagonist [LTRA] or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
Experimental: Dupilumab - Dupilumab 200 milligrams (mg) (in 1.14 milliliters [mL] for >30 kilograms [kg] bodyweight [BW]) or 100 mg (in 0.67 mL for less than or equal to (<=) 30 kg BW), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA] or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
Treatment: Drugs: Dupilumab
Pharmaceutical form: Solution
Route of administration: Subcutaneous
Treatment: Drugs: Placebo
Pharmaceutical form: Solution
Route of administration: Subcutaneous
Treatment: Drugs: Asthma Controller Therapies
Pharmaceutical form: Aerosol, capsules, tablets, oral solution
Route of administration: Inhaled, oral
Treatment: Drugs: Asthma Reliever Therapies
Pharmaceutical form: Nebulized, aerosol
Route of administration: Inhaled
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Annualized Rate of Severe Exacerbation Events During the 52-Week Treatment Period: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [1]
0
0
A severe asthma exacerbation event was defined as a deterioration of asthma during the 52-week treatment period requiring: use of systemic corticosteroids for >=3 days; and/or hospitalization or emergency room visit because of asthma requiring systemic corticosteroid treatment. Annualized event rate was defined as the total number of severe exacerbation events that occurred during the 52-week treatment period divided by the total number of participant-years followed in the 52-week treatment period.
Query!
Timepoint [1]
0
0
Baseline to Week 52
Query!
Primary outcome [2]
0
0
Annualized Rate of Severe Exacerbation Events During the 52-Week Treatment Period: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [2]
0
0
A severe asthma exacerbation event was defined as a deterioration of asthma during the 52-week treatment period requiring: use of systemic corticosteroids for >=3 days; and/or hospitalization or emergency room visit because of asthma requiring systemic corticosteroid treatment. Annualized event rate was defined as the total number of severe exacerbation events that occurred during the 52-week treatment period divided by the total number of participant-years followed in the 52-week treatment period.
Query!
Timepoint [2]
0
0
Baseline to Week 52
Query!
Secondary outcome [1]
0
0
Change From Baseline in Pre-bronchodilator Percent Predicted Forced Expiratory Volume in 1 (FEV1) Second at Week 12: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [1]
0
0
FEV1 was the volume of air (in liters) exhaled from the lungs in the first second of a forced expiration as measured by spirometer. LS means and SE were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 value up to Week 12 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by-visit interaction as covariates.
Query!
Timepoint [1]
0
0
Baseline, Week 12
Query!
Secondary outcome [2]
0
0
Change From Baseline in Pre-bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 12: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [2]
0
0
FEV1 was the volume of air (in liters) exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Least square (LS) means and standard error (SE) were derived from mixed-effect model with repeated measures (MMRM) model with change from baseline in pre-bronchodilator % predicted FEV1 value up to Week 12 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by-visit interaction as covariates.
Query!
Timepoint [2]
0
0
Baseline, Week 12
Query!
Secondary outcome [3]
0
0
Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-question Version (ACQ-7-IA) at Week 24: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [3]
0
0
ACQ-7-IA had 7 questions, which assessed: frequency of nocturnal awakenings, severity of asthma symptoms in the mornings, limitation of daily activities, shortness of breath due to asthma and wheeze, reliever medication use, and FEV1 (% predicted). Participants recalled their previous week asthma and answered 5 symptom questions on 7-point scale ranging from 0 (no impairment) to 6 (maximum impairment). Total score: mean of scores of all 7 questions; ranging from 0 (totally controlled) to 6 (severely uncontrolled), higher score indicated lower asthma control. LS means and SE were derived from MMRM model with change from baseline in ACQ-7-IA values up to Week 52 as response variable and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA value and baseline-by-visit interaction as covariates.
Query!
Timepoint [3]
0
0
Baseline, Week 24
Query!
Secondary outcome [4]
0
0
Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-question Version at Week 24: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [4]
0
0
ACQ-7-IA had 7 questions, which assessed: frequency of nocturnal awakenings, severity of asthma symptoms in the mornings, limitation of daily activities due to asthma, shortness of breath due to asthma and wheeze, reliever medication use, and FEV1 (% predicted). Participants recalled their previous week asthma and answered 5 symptom questions on 7-point scale ranging from 0 (no impairment) to 6 (maximum impairment). Total score: mean of scores of all 7 questions; ranging from 0 (totally controlled) to 6 (severely uncontrolled), higher score indicated lower asthma control. LS means and SE were derived from MMRM model with change from baseline in ACQ-7-IA values up to Week 52 as response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA value and baseline-by-visit interaction as covariates.
Query!
Timepoint [4]
0
0
Baseline, Week 24
Query!
Secondary outcome [5]
0
0
Change From Baseline in Fractional Exhaled Nitric Oxide Level at Week 12: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [5]
0
0
FeNO is a surrogate marker for airway inflammation. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/second, and reported in ppb. LS means and SE were derived from MMRM model with change from baseline in FeNO up to Week 12 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline ICS level, visit, treatment by-visit interaction, baseline FeNO value and baseline-by-visit interaction as covariates.
Query!
Timepoint [5]
0
0
Baseline, Week 12
Query!
Secondary outcome [6]
0
0
Change From Baseline in Fractional Exhaled Nitric Oxide Level at Week 12: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [6]
0
0
FeNO is a surrogate marker for airway inflammation. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/second, and reported in ppb. LS means and SE were derived from MMRM model with change from baseline in FeNO up to Week 12 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline ICS level, visit, treatment by-visit interaction, baseline FeNO value and baseline-by-visit interaction as covariates.
Query!
Timepoint [6]
0
0
Baseline, Week 12
Query!
Secondary outcome [7]
0
0
Change From Baseline in Pre-bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second at Weeks 2, 4, 8, 24, 36 and 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [7]
0
0
FEV1 was the volume of air (in liters) exhaled from the lungs in the first second of a forced expiration as measured by spirometer. LS means and SE were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 values up to Week 52 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by-visit interaction as covariates.
Query!
Timepoint [7]
0
0
Baseline, Weeks 2, 4, 8, 24, 36, 52
Query!
Secondary outcome [8]
0
0
Change From Baseline in Pre-bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second at Weeks 2, 4, 8, 24, 36 and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [8]
0
0
FEV1 was the volume of air (in liters) exhaled from the lungs in the first second of a forced expiration as measured by spirometer. LS means and SE were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 values up to Week 52 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by-visit interaction as covariates.
Query!
Timepoint [8]
0
0
Baseline, Weeks 2, 4, 8, 24, 36, 52
Query!
Secondary outcome [9]
0
0
Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During 52-week Treatment Period: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [9]
0
0
The time to first severe exacerbation was defined as date of the first severe exacerbation event - randomization date +1. A severe asthma exacerbation event was defined as a deterioration of asthma during the 52-week treatment period requiring: use of systemic corticosteroids for >=3 days; and/or hospitalization related to asthma symptoms or emergency room visit because of asthma requiring systemic corticosteroid treatment. Kaplan-Meier method was used for analysis.
Query!
Timepoint [9]
0
0
Baseline up to Week 52
Query!
Secondary outcome [10]
0
0
Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During 52-week Treatment Period: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [10]
0
0
The time to first severe exacerbation was defined as date of the first severe exacerbation event - randomization date +1. A severe asthma exacerbation event was defined as a deterioration of asthma during the 52-week treatment period requiring: use of systemic corticosteroids for >=3 days; and/or hospitalization related to asthma symptoms or emergency room visit because of asthma requiring systemic corticosteroid treatment. Kaplan-Meier method was used for analysis.
Query!
Timepoint [10]
0
0
Baseline up to Week 52
Query!
Secondary outcome [11]
0
0
Time to First Loss of Asthma Control (LOAC) Event: Kaplan-Meier Estimates During 52-week Treatment Period: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [11]
0
0
Time to first LOAC event was date of first LOAC event - first dose date +1. A LOAC event was defined as deterioration of asthma during 52-week treatment period that resulted in any of the following: >= 6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS dose >=4 times than dose at Visit 2 (Week 0); a decrease in ante meridiem (AM)/post meridiem (PM) peak flow of 30% or more on 2 consecutive days of treatment, based on defined stability limit (defined as respective mean AM/PM peak expiratory flow obtained over last 7 days prior to randomization (Day 1); severe exacerbation event. Kaplan-Meier method was used for analysis.
Query!
Timepoint [11]
0
0
Baseline up to Week 52
Query!
Secondary outcome [12]
0
0
Time to First Loss of Asthma Control Event: Kaplan-Meier Estimates During 52-week Treatment Period: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [12]
0
0
Time to first LOAC event was date of first LOAC event - first dose date +1. A LOAC event was defined as deterioration of asthma during 52-week treatment period that resulted in any of the following: >= 6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS dose >=4 times than dose at Visit 2 (Week 0); a decrease in AM/PM peak flow of 30% or more on 2 consecutive days of treatment, based on defined stability limit (defined as respective mean AM/PM peak expiratory flow obtained over last 7 days prior to randomization (Day 1); severe exacerbation event. Kaplan-Meier method was used for analysis.
Query!
Timepoint [12]
0
0
Baseline up to Week 52
Query!
Secondary outcome [13]
0
0
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [13]
0
0
FEV1 was the volume of air (in liters) exhaled from the lungs in the first second of a forced expiration as measured by spirometer. LS means and SE were derived from MMRM model with change from baseline in pre-bronchodilator FEV1 values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, sex, ethnicity, baseline height, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline pre-bronchodilator FEV1 value and baseline-by-visit interaction as covariates.
Query!
Timepoint [13]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [14]
0
0
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [14]
0
0
FEV1 was the volume of air (in liters) exhaled from the lungs in the first second of a forced expiration as measured by spirometer. LS means and SE were derived from MMRM model with change from baseline in pre-bronchodilator FEV1 values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, sex, ethnicity, baseline height, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline pre-bronchodilator FEV1 value and baseline-by-visit interaction as covariates.
Query!
Timepoint [14]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [15]
0
0
Percent Change From Baseline in Pre-Bronchodilator Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [15]
0
0
FEV1 was the volume of air (in liters) exhaled from the lungs in the first second of a forced expiration as measured by spirometer. LS means and SE were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 values up to Week 52 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by-visit interaction as covariates.
Query!
Timepoint [15]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [16]
0
0
Percent Change From Baseline in Pre-Bronchodilator Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [16]
0
0
FEV1 was the volume of air (in liters) exhaled from the lungs in the first second of a forced expiration as measured by spirometer. LS means and SE were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 values up to Week 52 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by-visit interaction as covariates.
Query!
Timepoint [16]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [17]
0
0
Change From Baseline in Morning (AM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [17]
0
0
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for AM PEF was performed in morning prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol reliever medication. Baseline AM PEF was the mean AM measurement recorded for the 7 days prior to the first dose of investigational product. LS means and SE were derived from MMRM model with change from baseline in AM PEF (liters/minute) values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline AM PEF (liters/minute) value and baseline-by-visit interaction as covariates.
Query!
Timepoint [17]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [18]
0
0
Change From Baseline in Evening (PM) Peak Expiratory Flow at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [18]
0
0
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PM PEF was performed in evening prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol reliever medication. Baseline PM PEF was the mean PM measurement recorded for the 7 days prior to the first dose of investigational product. LS means and SE were derived from MMRM model with change from baseline in PM PEF (liters/minute) values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline PM PEF (liters/minute) value and baseline-by-visit interaction as covariates.
Query!
Timepoint [18]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [19]
0
0
Change From Baseline in Morning (AM) Peak Expiratory Flow at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [19]
0
0
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for AM PEF was performed in morning prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol reliever medication. Baseline AM PEF was the mean AM measurement recorded for the 7 days prior to the first dose of investigational product. LS means and SE were derived from MMRM model with change from baseline in AM PEF (liters/minute) values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline AM PEF (liters/minute) value and baseline-by-visit interaction as covariates.
Query!
Timepoint [19]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [20]
0
0
Change From Baseline in Evening (PM) Peak Expiratory Flow at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [20]
0
0
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PM PEF was performed in evening prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol reliever medication. Baseline PM PEF was the mean PM measurement recorded for the 7 days prior to the first dose of investigational product. LS means and SE were derived from MMRM model with change from baseline in PM PEF (liters/minute) values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline PM PEF (liters/minute) value and baseline-by-visit interaction as covariates.
Query!
Timepoint [20]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [21]
0
0
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [21]
0
0
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position, measured in liters. LS means and SE were derived from MMRM model with change from baseline in FVC values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, sex, ethnicity, baseline height, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FVC value and baseline-by-visit interaction as covariates.
Query!
Timepoint [21]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [22]
0
0
Change From Baseline in Forced Vital Capacity at Weeks 2, 4, 8, 12, 24, 36, 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [22]
0
0
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position, measured in liters. LS means and SE were derived from MMRM model with change from baseline in FVC values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, sex, ethnicity, baseline height, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FVC value and baseline-by-visit interaction as covariates.
Query!
Timepoint [22]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [23]
0
0
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [23]
0
0
FEF is the amount of air (in liters) which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position. LS means and SE were derived from MMRM model with change from baseline in FEF 25-75% values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, sex, ethnicity, baseline height, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEF 25-75% value and baseline-by-visit interaction as covariates.
Query!
Timepoint [23]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [24]
0
0
Change From Baseline in Forced Expiratory Flow 25-75% at Weeks 2, 4, 8, 12, 24, 36, 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [24]
0
0
FEF is the amount of air (in liters) which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position. LS means and SE were derived from MMRM model with change from baseline in FE F25-75% values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, sex, ethnicity, baseline height, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEF 25-75% value and baseline-by-visit interaction as covariates.
Query!
Timepoint [24]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [25]
0
0
Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [25]
0
0
Participants were assessed for post-bronchodilator FEV1 30 minutes after bronchodilator administration (200 to 400 mg [2 to 4 puffs] of albuterol/salbutamol or 45 to 90 micrograms [2 to 4 puffs] of levalbuterol/levosalbutamol). FEV1 was the volume of air (in liters) exhaled in the first second of a forced expiration as measured by spirometer. LS means and SE were derived from MMRM model with change from baseline in post-bronchodilator FEV1 values up to Week 52 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline post-bronchodilator FEV1 value and baseline-by-visit interaction as covariates.
Query!
Timepoint [25]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [26]
0
0
Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [26]
0
0
Participants were assessed for post-bronchodilator FEV1 30 minutes after bronchodilator administration (200 to 400 mg [2 to 4 puffs] of albuterol/salbutamol or 45 to 90 micrograms [2 to 4 puffs] of levalbuterol/levosalbutamol). FEV1 was the volume of air (in liters) exhaled in the first second of a forced expiration as measured by spirometer. LS means and SE were derived from MMRM model with change from baseline in post-bronchodilator FEV1 values up to Week 52 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline post-bronchodilator FEV1 value and baseline-by-visit interaction as covariates.
Query!
Timepoint [26]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [27]
0
0
Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [27]
0
0
The morning asthma symptom score evaluated participant's overall asthma symptoms experienced during the previous night. It ranged from 0 (no asthma symptoms, slept through the night) to 4 (bad night, awake most of the night because of asthma), where lower scores indicate more mild symptoms and higher scores indicate more severe symptoms. LS means and SE were derived from MMRM model with change from baseline in AM asthma symptom score values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline AM asthma symptom score value and baseline-by-visit interaction as covariates.
Query!
Timepoint [27]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [28]
0
0
Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [28]
0
0
The evening asthma symptom score evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 (very well, no asthma symptoms) to 4 (asthma very bad, unable to carry out daily activities as usual), where lower scores indicate more mild symptoms and higher scores indicate more severe symptoms. LS means and SE were derived from MMRM model with change from baseline in PM asthma symptom score values up to Week 52 as response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline PM asthma symptom score value and baseline-by-visit interaction as covariates.
Query!
Timepoint [28]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [29]
0
0
Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [29]
0
0
The morning asthma symptom score evaluated participant's overall asthma symptoms experienced during the previous night. It ranged from 0 (no asthma symptoms, slept through the night) to 4 (bad night, awake most of the night because of asthma), where lower scores indicate more mild symptoms and higher scores indicate more severe symptoms. LS means and SE were derived from MMRM model with change from baseline in AM asthma symptom score values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline AM asthma symptom score value and baseline-by-visit interaction as covariates.
Query!
Timepoint [29]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [30]
0
0
Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [30]
0
0
The evening asthma symptom score evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 (very well, no asthma symptoms) to 4 (asthma very bad, unable to carry out daily activities as usual), where lower scores indicate more mild symptoms and higher scores indicate more severe symptoms. LS means and SE were derived from MMRM model with change from baseline in PM asthma symptom score values up to Week 52 as response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline PM asthma symptom score value and baseline-by-visit interaction as covariates.
Query!
Timepoint [30]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [31]
0
0
Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-question Version (ACQ-5-IA) at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [31]
0
0
ACQ-5-IA has 5 questions, reflecting top-scoring 5 asthma symptoms: frequency of nocturnal awakenings, severity of asthma symptoms in the mornings, limitation of daily activities, shortness of breath due to asthma and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranging from 0 (no impairment) to 6 (maximum impairment). ACQ-5-IA total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control. LS means and SE were derived from MMRM model with change from baseline in ACQ-5-IA values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-5-IA value and baseline-by-visit interaction as covariates.
Query!
Timepoint [31]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [32]
0
0
Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-question Version at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [32]
0
0
ACQ-5-IA has 5 questions, reflecting top-scoring 5 asthma symptoms: frequency of nocturnal awakenings, severity of asthma symptoms in the mornings, limitation of daily activities, shortness of breath due to asthma and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranging from 0 (no impairment) to 6 (maximum impairment). ACQ-5-IA total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control. LS means and SE were derived from MMRM model with change from baseline in ACQ-5-IA values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-5-IA value and baseline-by-visit interaction as covariates.
Query!
Timepoint [32]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [33]
0
0
Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-question Version at Weeks 2, 4, 8, 12, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [33]
0
0
ACQ-7-IA had 7 questions, assessed: frequency of nocturnal awakenings, severity of asthma symptoms in the mornings, limitation of daily activities, shortness of breath due to asthma and wheeze, reliever medication use, and FEV1 (% predicted). Participants recalled their previous week asthma and answered 5 symptom questions on 7-point scale ranging from 0 (no impairment) to 6 (maximum impairment). Total score:mean of scores of all 7 questions; ranging from 0 (totally controlled) to 6 (severely uncontrolled), higher score indicated lower asthma control. LS means and SE were derived from MMRM model with change from baseline in ACQ-7-IA values up to Week 52 as response variable and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA value and baseline-by-visit interaction as covariates.
Query!
Timepoint [33]
0
0
Baseline, Weeks 2, 4, 8,12, 36, 52
Query!
Secondary outcome [34]
0
0
Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-question Version at Weeks 2, 4, 8, 12, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [34]
0
0
ACQ-7-IA had 7 questions, assessed: frequency of nocturnal awakenings, severity of asthma symptoms in the mornings, limitation of daily activities due to asthma, shortness of breath due to asthma and wheeze, reliever medication use, and FEV1 (% predicted). Participants recalled their previous week asthma and answered 5 symptom questions on 7-point scale ranging from 0 (no impairment) to 6 (maximum impairment). Total score: mean of scores of all 7 questions; ranging from 0 (totally controlled) to 6 (severely uncontrolled), higher score indicated lower asthma control. LS means and SE were derived from MMRM model with change from baseline in ACQ-7-IA values up to Week 52 as response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA value and baseline-by-visit interaction as covariates.
Query!
Timepoint [34]
0
0
Baseline, Weeks 2, 4, 8,12, 36, 52
Query!
Secondary outcome [35]
0
0
Change From Baseline in Number of Puffs of Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [35]
0
0
Participants might be administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed. Number of reliever medication inhalations were recorded daily in electronic diary/PEF meter. When Nebulizer solutions were used as alternative delivery method, nebulizer dose was converted to number of puffs as per conversion factor: salbutamol/albuterol nebulizer solution (2.5 mg) and levosalbutamol/levalbuterol (1.25 mg) corresponds to 4 puffs. Change From Baseline in number of puffs of reliever medication used per 24 hours at specified weeks was reported. LS means and SE were derived from MMRM model with change from baseline in number of puffs of reliever medication/24 hours values up to Week 52 as response variable and treatment, age, baseline: weight group, region, eosinophil level, FeNO level, ICS dose level, visit, treatment by-visit interaction, baseline number of puffs of reliever medication/24 hours value and baseline-by-visit interaction as covariates.
Query!
Timepoint [35]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [36]
0
0
Change From Baseline in Number of Puffs of Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [36]
0
0
Participants might be administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed. Number of reliever medication inhalations were recorded daily in electronic diary/PEF meter. When Nebulizer solutions were used as alternative delivery method, nebulizer dose was converted to number of puffs as per conversion factor: salbutamol/albuterol nebulizer solution (2.5 mg) and levosalbutamol/levalbuterol (1.25 mg) corresponds to 4 puffs. Change From Baseline in number of puffs of reliever medication used per 24 hours at specified weeks was reported. LS means and SE were derived from MMRM model with change from baseline in number of puffs of reliever medication/24 hours values up to Week 52 as response variable and treatment, age, baseline: weight group, region, eosinophil level, FeNO level, ICS dose level, visit, treatment by-visit interaction, baseline number of puffs of reliever medication/24 hours value and baseline-by-visit interaction as covariates.
Query!
Timepoint [36]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [37]
0
0
Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [37]
0
0
Participants recorded every morning the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night. Change from baseline in number of nocturnal awakenings per night at specified weeks was reported. LS means and SE were derived from MMRM model with change from baseline in number of nocturnal awakenings values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline number of nocturnal awakenings value and baseline-by-visit interaction as covariates.
Query!
Timepoint [37]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [38]
0
0
Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [38]
0
0
Participants recorded every morning the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night. Change from baseline in number of nocturnal awakenings per night at specified weeks was reported. LS means and SE were derived from MMRM model with change from baseline in number of nocturnal awakenings values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline number of nocturnal awakenings value and baseline-by-visit interaction as covariates.
Query!
Timepoint [38]
0
0
Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
Query!
Secondary outcome [39]
0
0
Change From Baseline in Pediatric Asthma Quality of Life (QoL) Questionnaire With Standardized Activities-Interviewer Administered (PAQLQ[S] IA) Scores at Weeks 12, 24, 36, and 52: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [39]
0
0
PAQLQ(S)-IA, a disease-specific, interviewer-administered QoL questionnaire designed to measure functional impairments that are most important to children >=7 years with asthma. The PAQLQ(S)-IA comprises of 23 items in 3 domains: symptoms (10 items), activity limitation (5 items) and emotional function (8 items). Each item was scored on a 7-point likert scale (1=maximal impairment to 7=no impairment). 23 items of questionnaire were averaged to produce 1 overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all), higher scores indicated better quality of life. LS means and SE were derived from MMRM model with change from baseline in PAQLQ(S)-IA global score values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline PAQLQ(S)-IA global score value and baseline-by-visit interaction as covariates.
Query!
Timepoint [39]
0
0
Baseline, Weeks 12, 24, 36, 52
Query!
Secondary outcome [40]
0
0
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire With Standardized Activities-Interviewer Administered Scores at Weeks 12, 24, 36, and 52: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [40]
0
0
PAQLQ(S)-IA, a disease-specific, interviewer-administered QoL questionnaire designed to measure functional impairments that are most important to children >=7 years with asthma. The PAQLQ(S)-IA comprises of 23 items in 3 domains: symptoms (10 items), activity limitation (5 items) and emotional function (8 items). Each item was scored on a 7-point likert scale (1=maximal impairment to 7=no impairment). 23 items of questionnaire were averaged to produce 1 overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all), higher scores indicated better quality of life. LS means and SE were derived from MMRM model with change from baseline in PAQLQ(S)-IA global score values up to Week 52 as the response variable, and treatment, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline PAQLQ(S)-IA global score value and baseline-by-visit interaction as covariates.
Query!
Timepoint [40]
0
0
Baseline, Weeks 12, 24, 36, 52
Query!
Secondary outcome [41]
0
0
Healthcare Resource Utilization (HCRU): Number of School and Work Days Missed Due to LOAC: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [41]
0
0
The number of days missed from school by the participant and the number of days missed from work by the caregiver of participant due to a LOAC were collected in the electronic-case report form (eCRF). Cumulative number of missed days (school days and work days) up to week 52 were computed and summarized using mean and standard deviation (SD).
Query!
Timepoint [41]
0
0
Baseline to Week 52
Query!
Secondary outcome [42]
0
0
Healthcare Resource Utilization: Number of School and Work Days Missed Due to LOAC: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [42]
0
0
The number of days missed from school by the participant and the number of days missed from work by the caregiver of participant due to a LOAC were collected in the eCRF. Cumulative number of missed days (school days and work days) up to week 52 were computed and summarized using mean and SD.
Query!
Timepoint [42]
0
0
Baseline to Week 52
Query!
Secondary outcome [43]
0
0
Healthcare Resource Utilization: Percentage of Participants Who Had Missed Greater Than or Equal to 5 School/Work Days Due to LOAC: Type 2 Inflammatory Asthma Phenotype Population
Query!
Assessment method [43]
0
0
The number of days missed from school for the participant and the missed number of days from work for the caregiver due to a LOAC were collected in the eCRF. The percentage of participants who had at least 5 days (school days and work days) missed due to LOAC over the study period was reported.
Query!
Timepoint [43]
0
0
Baseline to Week 52
Query!
Secondary outcome [44]
0
0
Healthcare Resource Utilization: Percentage of Participants Who Had Missed Greater Than or Equal to 5 School/Work Days Due to LOAC: Baseline Blood Eosinophils >=300 Cells Per Microliter Population
Query!
Assessment method [44]
0
0
The number of days missed from school for the participant and the missed number of days from work for the caregiver due to a LOAC were collected in the eCRF. The percentage of participants who had at least 5 days (school days and work days) missed due to LOAC over the study period was reported.
Query!
Timepoint [44]
0
0
Baseline to Week 52
Query!
Secondary outcome [45]
0
0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Query!
Assessment method [45]
0
0
Adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and did not necessary have to had a causal relationship with treatment.TEAEs were defined as AEs that developed or worsened in grade or became serious during TEAE period which was defined as the period from the time of first dose of study drug to the end of post-treatment period. A serious adverse events (SAE) was any untoward medical occurrence that at any dose resulted in: death; or life-threatening experience; or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity; or was a congenital anomaly/birth defect or a medically important event. TEAEs included both SAEs and non-SAEs.
Query!
Timepoint [45]
0
0
From Baseline up to Week 64
Query!
Secondary outcome [46]
0
0
Pharmacokinetics (PK) Assessment: Functional Dupilumab Concentration in Serum
Query!
Assessment method [46]
0
0
Data for this outcome measure was planned to be collected and analyzed separately for dupilumab 100 mg and 200 mg dose and not planned to be collected and analyzed for placebo arm.
Query!
Timepoint [46]
0
0
Baseline, Weeks 6, 12, 24, 52, 64
Query!
Secondary outcome [47]
0
0
Percentage of Participants With Treatment Emergent Antidrug Antibodies (ADA) Response
Query!
Assessment method [47]
0
0
ADA response was categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as an ADA positive response in the assay post first dose, when baseline results were negative or missing. 2) Treatment boosted was defined as: an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive. The criteria for positive was defined as "30 to > 10,000", where low titer (< 1,000); moderate (1,000 <= titer <= 10,000) and high titer (> 10,000).
Query!
Timepoint [47]
0
0
From Baseline up to Week 64
Query!
Secondary outcome [48]
0
0
Percentage of Participants With Seroconversion
Query!
Assessment method [48]
0
0
Seroconversion was defined as a post-vaccination titer >=40 (1/dilution) for those with a pre-vaccination titer <10 (1/dilution), or a >= 4-fold increase in post-vaccination titer for those with a pre-vaccination titer >=10 (1/dilution).
Query!
Timepoint [48]
0
0
From Baseline up to Week 64
Query!
Eligibility
Key inclusion criteria
Inclusion criteria :
Children 6 to <12 years of age, with a physician diagnosis of persistent asthma for greater
than or equal to (>=)12 months prior to screening, based on clinical history and
examination, pulmonary function parameters according to Global initiative for asthma (GINA)
2015 Guidelines and the following criteria:
- Existing background therapy of medium-dose ICS with second controller medication
(i.e., long-acting ß2 agonist , leukotriene receptor antagonist, long acting
muscarinic antagonist, or methylxanthines) or high-dose ICS alone or high-dose ICS
with second controller, for at least 3 months with a stable dose >=1 month prior to
Screening Visit 1.
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) <=95 percentage (%) of
predicted normal or pre bronchodilator FEV1/forced vital capacity ratio <0.85 at
Screening and Baseline Visits.
- Reversibility of at least 10% in FEV1 after the administration of 200 to 400
micrograms (mcg; 2 to 4 puff inhalations with metered-dose inhaler [MDI]) of
albuterol/salbutamol or 45 to 90 mcg (2 to 4 puffs with MDI) of
levalbuterol/levosalbutamol reliever medication before randomization (up to 3
opportunities during the same visit were allowed with a maximum of 12 puffs of
reliever medication if tolerated by the participant).
- Must had experienced, within 1 year prior to Screening Visit 1, any of the following
events:
- Treatment with a systemic corticosteroid (oral or parenteral), as prescribed by a
healthcare professional for worsening asthma at least once or,
- Hospitalization or emergency visit for worsening asthma.
- Evidence of uncontrolled asthma, with at least one of the following criteria during
the 4 (±1) weeks Screening Period:
- Asthma Control Questionnaire-Interviewer Administered (ACQ-IA) ACQ-5 score >=1.5
on at least one day of the Screening Period.
- Use of reliever medication (i.e., albuterol/salbutamol or
levalbuterol/levosalbutamol), other than as a preventive for exercise induced
bronchospasm, on 3 or more days per week, in at least one week during the
Screening Period.
- Sleep awakening due to asthma symptoms requiring use of reliever medication at
least once during the Screening Period.
- Asthma symptoms 3 or more days per week in at least one week during the Screening
Period.
Query!
Minimum age
6
Years
Query!
Query!
Maximum age
11
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria:
- Participants <6 or >=12 years of age.
- Participants with <16 kg bodyweight.
- Any other chronic lung disease (cystic fibrosis, bronchopulmonary dysplasia, etc.),
which may impair lung function.
- A participant with any history of life threatening asthma (ie, extreme exacerbation
that requires intubation).
- Co-morbid disease that might interfere with the evaluation of investigational
medicinal product.
The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/04/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
26/08/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
408
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Investigational Site Number 036001 - Campbelltown
Query!
Recruitment hospital [2]
0
0
Investigational Site Number 036005 - North Adelaide
Query!
Recruitment hospital [3]
0
0
Investigational Site Number 036003 - Parkville/Melbourne
Query!
Recruitment hospital [4]
0
0
Investigational Site Number 036002 - South Brisbane
Query!
Recruitment postcode(s) [1]
0
0
2560 - Campbelltown
Query!
Recruitment postcode(s) [2]
0
0
5006 - North Adelaide
Query!
Recruitment postcode(s) [3]
0
0
3052 - Parkville/Melbourne
Query!
Recruitment postcode(s) [4]
0
0
4101 - South Brisbane
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Kentucky
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Michigan
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Missouri
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Nebraska
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
North Carolina
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Ohio
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Oklahoma
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Wisconsin
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Buenos Aires
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Caba
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Mendoza
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Blumenau
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
Porto Alegre
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Sao Paulo
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Sorocaba
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Edmonton
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Hamilton
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Montreal
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Quebec
Query!
Country [25]
0
0
Chile
Query!
State/province [25]
0
0
Santiago
Query!
Country [26]
0
0
Chile
Query!
State/province [26]
0
0
Valdivia
Query!
Country [27]
0
0
Chile
Query!
State/province [27]
0
0
Viña Del Mar
Query!
Country [28]
0
0
Colombia
Query!
State/province [28]
0
0
Antioquia
Query!
Country [29]
0
0
Colombia
Query!
State/province [29]
0
0
Cali
Query!
Country [30]
0
0
Hungary
Query!
State/province [30]
0
0
Budapest
Query!
Country [31]
0
0
Hungary
Query!
State/province [31]
0
0
Gyula
Query!
Country [32]
0
0
Hungary
Query!
State/province [32]
0
0
Mezokövesd
Query!
Country [33]
0
0
Hungary
Query!
State/province [33]
0
0
Szeged
Query!
Country [34]
0
0
Hungary
Query!
State/province [34]
0
0
Szigetvár
Query!
Country [35]
0
0
Hungary
Query!
State/province [35]
0
0
Székesfehérvár
Query!
Country [36]
0
0
Hungary
Query!
State/province [36]
0
0
Töröbálint
Query!
Country [37]
0
0
Hungary
Query!
State/province [37]
0
0
Zalaegerszeg
Query!
Country [38]
0
0
Italy
Query!
State/province [38]
0
0
Catania
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Firenze
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
Padova
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Roma
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Verona
Query!
Country [43]
0
0
Lithuania
Query!
State/province [43]
0
0
Kaunas
Query!
Country [44]
0
0
Lithuania
Query!
State/province [44]
0
0
Siauliai
Query!
Country [45]
0
0
Lithuania
Query!
State/province [45]
0
0
Utena
Query!
Country [46]
0
0
Lithuania
Query!
State/province [46]
0
0
Vilnius
Query!
Country [47]
0
0
Mexico
Query!
State/province [47]
0
0
Chihuahua
Query!
Country [48]
0
0
Mexico
Query!
State/province [48]
0
0
Durango
Query!
Country [49]
0
0
Mexico
Query!
State/province [49]
0
0
Monterrey
Query!
Country [50]
0
0
Mexico
Query!
State/province [50]
0
0
Veracruz
Query!
Country [51]
0
0
Poland
Query!
State/province [51]
0
0
Lodz
Query!
Country [52]
0
0
Poland
Query!
State/province [52]
0
0
Poznan
Query!
Country [53]
0
0
Romania
Query!
State/province [53]
0
0
Bucuresti
Query!
Country [54]
0
0
Russian Federation
Query!
State/province [54]
0
0
Moscow
Query!
Country [55]
0
0
Russian Federation
Query!
State/province [55]
0
0
Perm
Query!
Country [56]
0
0
Russian Federation
Query!
State/province [56]
0
0
Saint Petersburg
Query!
Country [57]
0
0
Russian Federation
Query!
State/province [57]
0
0
Saint-Petersburg
Query!
Country [58]
0
0
South Africa
Query!
State/province [58]
0
0
Cape Town
Query!
Country [59]
0
0
Spain
Query!
State/province [59]
0
0
Barcelona
Query!
Country [60]
0
0
Spain
Query!
State/province [60]
0
0
Esplugues De Llobregat
Query!
Country [61]
0
0
Spain
Query!
State/province [61]
0
0
Pozuelo De Alarcón
Query!
Country [62]
0
0
Spain
Query!
State/province [62]
0
0
Santiago De Compostela
Query!
Country [63]
0
0
Spain
Query!
State/province [63]
0
0
Valencia
Query!
Country [64]
0
0
Turkey
Query!
State/province [64]
0
0
Adana
Query!
Country [65]
0
0
Turkey
Query!
State/province [65]
0
0
Ankara
Query!
Country [66]
0
0
Turkey
Query!
State/province [66]
0
0
Bursa
Query!
Country [67]
0
0
Turkey
Query!
State/province [67]
0
0
Istanbul
Query!
Country [68]
0
0
Ukraine
Query!
State/province [68]
0
0
Chernivtsi
Query!
Country [69]
0
0
Ukraine
Query!
State/province [69]
0
0
Dnipro
Query!
Country [70]
0
0
Ukraine
Query!
State/province [70]
0
0
Ivano-Frankivsk
Query!
Country [71]
0
0
Ukraine
Query!
State/province [71]
0
0
Kharkiv
Query!
Country [72]
0
0
Ukraine
Query!
State/province [72]
0
0
Kryvyi Rig
Query!
Country [73]
0
0
Ukraine
Query!
State/province [73]
0
0
Kyiv
Query!
Country [74]
0
0
Ukraine
Query!
State/province [74]
0
0
Zaporizhzhya
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Sanofi
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Regeneron Pharmaceuticals
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Primary Objective:
To evaluate the efficacy of dupilumab in children 6 to less than (<) 12 years of age with
uncontrolled persistent asthma.
Secondary Objective:
To evaluate in children 6 to <12 years of age with uncontrolled persistent asthma:
- The safety and tolerability of dupilumab.
- The evaluate the effect of dupilumab in improving participant reported outcomes
including health related quality of life.
- The dupilumab systemic exposure and incidence of anti-drug antibodies.
- The evaluate the association between dupilumab treatment and pediatric immune responses
to vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal
trivalent/quadrivalent influenza vaccine.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02948959
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Sciences & Operations
Query!
Address
0
0
Sanofi
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02948959
Download to PDF