| Primary | Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. TEAEs were AEs that developed or worsened or became serious during the TEAE period. | Safety population included all participants exposed to at least 1 dose or part of a dose of the study treatment during current study regardless of the amount of treatment administered. | Posted | | Count of Participants | | Participants | | From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks | | | | ID | Title | Description |
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| OG000 | Main Study: Placebo-Dupilumab | Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
| | OG001 | Main Study: Dupilumab-Dupilumab | Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
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| Primary | Japan Sub-study: Change From Baseline to Week 12 in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) | FEV1 was the volume of air (in liters) exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available measurement prior to the first study treatment dose if the participant was treated, or the last available value up to enrollment if the participant was not exposed to study treatment in the current study. | Intent-to-treat (ITT) population included all participants in the enrolled population in the current study. | Posted | | Mean | Standard Deviation | percent predicted FEV1 | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
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| OG000 | Japan Sub-study: Dupilumab | Participants received dupilumab for 52 weeks in the Japan sub-study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
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| Secondary | Japan Sub-study: Number of Participants With Any Treatment-Emergent Adverse Events | An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. TEAEs were AEs that developed or worsened or became serious during the TEAE period. | Safety population included all enrolled participants who took at least 1 dose of study treatment in the current study, regardless of the amount of treatment administered. | Posted | | Count of Participants | | Participants | | From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks | | | | ID | Title | Description |
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| OG000 | Japan Sub-study: Dupilumab | Participants received dupilumab for 52 weeks in the Japan sub-study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
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| Secondary | Annualized Rate of Severe Asthma Exacerbation Events During the 52-Week Treatment Period | A severe exacerbation event during study was defined as a deterioration of asthma requiring use of systemic corticosteroid (SCS) for ≥3 days or hospitalization/emergency room visit because of asthma, requiring SCS. Annualized severe exacerbation event rate was defined as total number of events that occurred during 52-week treatment period divided by total number of participant-years followed in 52-week treatment period. | Main study: safety population included all participants exposed to at least 1 dose or part of a dose of study treatment during current study regardless of amount of treatment administered. Sub-study: ITT population included all participants in enrolled population in the current study. | Posted | | Number | | exacerbations per participant-years | | Up to Week 52 | | | | ID | Title | Description |
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| OG000 | Main Study: Placebo-Dupilumab | Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
| | OG001 |
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| Secondary | Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time | FEV1 was volume of air (in liters) exhaled from the lungs in first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study. | Main study: safety population included all participants exposed to at least 1 dose or part of a dose of study treatment during current study regardless of amount of treatment administered. Sub-study: ITT population included all participants in enrolled population in current study. Only participants with data collected at the specified timepoints are reported. | Posted | | Mean | Standard Deviation | percent predicted FEV1 | | Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64 | | | | ID | Title | Description |
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| OG000 | Main Study: Placebo-Dupilumab | Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
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| Secondary | Change From Baseline in Absolute Forced Expiratory Volume in 1 Second Over Time | FEV1 was volume of air (in liters) exhaled from the lungs in first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study. | Main study: safety population included all participants exposed to at least 1 dose or part of a dose of study treatment during current study regardless of amount of treatment administered. Sub-study: ITT population included all participants in enrolled population in current study. Only participants with data collected at the specified timepoints are reported. | Posted | | Mean | Standard Deviation | liter | | Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64 | | | | ID | Title | Description |
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| OG000 | Main Study: Placebo-Dupilumab | Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
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| Secondary | Change From Baseline in Forced Vital Capacity (FVC) Over Time | FVC was defined as volume of air (in liters) that could be forcibly blown out after full inspiration in upright position as measured by spirometer. Spirometry was performed after wash out period of bronchodilators according to their action duration. Baseline (main study):original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated or last available value up to enrollment if participant was not exposed to study treatment in current study. | Main study: safety population included all participants exposed to at least 1 dose or part of a dose of study treatment during current study regardless of amount of treatment administered. Sub-study: ITT population included all participants in enrolled population in current study. Only participants with data collected at the specified timepoints are reported. | Posted | | Mean | Standard Deviation | liter | | Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64 | | | | ID | Title | Description |
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| OG000 | Main Study: Placebo-Dupilumab | Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
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| Secondary | Change From Baseline in Forced Expiratory Flow [FEF] 25% to 75% Over Time | FEF was defined as amount of air which can be forcibly exhaled from lungs in first second of forced exhalation. FEF 25-75% was the mean FEF between 25% and 75% of FVC. FVC was defined as volume of air that could be forcibly blown out after full inspiration in upright position. Spirometry was performed after wash out period of bronchodilators. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated or last available value up to enrollment if participant was not exposed to study treatment in current study. | Main study: safety population included all participants exposed to at least 1 dose or part of dose of study treatment during current regardless of amount of treatment administered. Sub-study: ITT population included all participants in enrolled population in current study. Only participants with data collected at specified timepoints are reported. | Posted | | Mean | Standard Deviation | liter per second | | Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64 | | | | ID | Title | Description |
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| OG000 | Main Study: Placebo-Dupilumab | Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
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| Secondary | Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity Over Time | FVC was defined as volume of air (in liters) that could be forcibly blown out after full inspiration in upright position as measured by spirometer. Spirometry was performed after wash out period of bronchodilators according to their action duration. Baseline was defined as the original baseline of parent study EFC14153. | Safety population included all participants exposed to at least 1 dose or part of a dose of study treatment during current study regardless of amount of treatment administered. Only participants with data collected at the specified timepoints are reported. | Posted | | Mean | Standard Deviation | percent predicted FVC | | Baseline (Day 1) and Weeks 2, 8, 12, 24, 52 and 64 | | | | ID | Title | Description |
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| OG000 | Main Study: Placebo-Dupilumab | Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
| | OG001 | Main Study: Dupilumab-Dupilumab |
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| Secondary | Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time | ACQ-7-IA had 7 questions with first 5 items of ACQ-7 addressing most common asthma symptoms: frequency in past week awoken by asthma during night, severity of asthma symptoms in morning, limitation of daily activities due to asthma, shortness of breath due to asthma, wheeze; 2 questions on short-acting bronchodilator use and predicted bronchodilator use of FEV1. Participants/parents/guardians recalled child's previous week asthma and responded to questions on 7-point scale: 0=no impairment, 6=maximum impairment. Global ACQ-7-IA score was the mean of 7 questions, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated lower asthma control. Baseline: last available measurement prior to first study treatment dose if participant was treated or last available value up to enrollment if participant was not exposed to study treatment in current study. | ITT population included all participants in enrolled population in current study. Only participants with data collected at specified timepoints are reported | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64 | | | | ID | Title | Description |
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| OG000 | Japan Sub-study: Dupilumab | Participants received dupilumab for 52 weeks in the Japan sub-study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
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| Secondary | Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time | The ACQ-5-IA had 5 questions addressing most common asthma symptoms: frequency in past week awoken by asthma during night, severity of asthma symptoms in morning, limitation of daily activities due to asthma, shortness of breath due to asthma and wheeze. Participants/parents/guardians recalled the child's previous week asthma and responded to symptom and bronchodilator use questions on a 7-point scale: 0=no impairment, 6=maximum impairment. Global ACQ-5-IA score was the mean of 5 questions, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. Baseline: last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study. | ITT population included all participants in enrolled population in current study. Only participants with data collected at specified timepoints are reported | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64 | | | | ID | Title | Description |
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| OG000 | Japan Sub-study: Dupilumab | Participants received dupilumab for 52 weeks in the Japan sub-study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
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| Secondary | Serum Concentrations of Dupilumab | Blood samples were collected at the specified timepoints for determination of functional dupilumab concentration in serum. | Pharmacokinetic population:participants in safety population with atleast 1 nonmissing;evaluable predose serum concentration post 1st dose of dupilumab in current study.Only participants with data collected at specified timepoints are reported.As prespecified in SAP,serum concentration is presented by dose regimen.Main study:dose regimen was adjusted per participant's weight during study,hence some participants may be counted in more than 1 dose regimen across different weeks based on weight. | Posted | | Mean | Standard Deviation | nanogram per milliliter | | Weeks 12, 24, 52 and 64 | | | | ID | Title | Description |
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| OG000 | Main Study: Dupilumab 100 mg q2w | All participants from the main study who received dupilumab 100 mg q2w were included in this arm. | | OG001 | Main Study: Dupilumab 200 mg q2w | All participants from the main study who received dupilumab 200 mg q2w were included in this arm. | | OG002 | Main Study: Dupilumab 300 mg q4w | All participants from the main study who received dupilumab 300 mg q4w were included in this arm. |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADAs) Against Dupilumab | ADA positive was defined as either treatment-boosted or treatment-emergent response in the ADA assay. Treatment-boosted response was defined as a positive response in the ADA assay post first dose in the current study that was greater than or equal to 4-fold of the baseline titer levels, when baseline results were positive. Treatment-emergent response was defined as a positive response in the ADA assay post first dose in the current study, when baseline results were negative or missing. Baseline (main study): original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study. | ADA population (main and sub-study) included all the participants in the safety population with at least 1 non-missing ADA result following the first dose of dupilumab in the current study. Only participants with data collected for the specified categories are reported. | Posted | | Count of Participants | | Participants | | From first dose of study treatment (Day 1) to Week 64 | | | | ID | Title | Description |
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| OG000 | Main Study: Placebo-Dupilumab | Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
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| Secondary | Main Study: Percent Change From Baseline in Blood Eosinophil Count at Week 64 | Blood samples were collected at specified timepoints to assess percent change from baseline in eosinophil count. Baseline was defined as the original baseline of parent study EFC14153. | Safety population included all participants exposed to at least 1 dose or part of a dose of the study treatment during current study regardless of the amount of treatment administered. Only participants with data collected are reported. | Posted | | Mean | Standard Deviation | percent change | | Baseline (Day 1) to Week 64 | | | | ID | Title | Description |
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| OG000 | Main Study: Placebo-Dupilumab | Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
| | OG001 | Main Study: Dupilumab-Dupilumab | Participants who received dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
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| Secondary | Percent Change From Baseline in Total Immunoglobulin (Ig) E in Serum at Week 64 | Blood samples were collected at specified timepoints to assess percent change from baseline in total IgE in serum. Baseline (main study): the original baseline of parent study EFC14153. Baseline (sub-study): last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in current study. | Main study: safety population included all participants exposed to at least 1 dose or part of a dose of the study treatment during current study regardless of the amount of treatment administered. Sub-study: safety population included all enrolled participants who took at least 1 dose of study treatment in the current study, regardless of the amount of treatment administered. Only participants with data collected are reported. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline (Day 1) to Week 64 | | | | ID | Title | Description |
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| OG000 | Main Study: Placebo-Dupilumab | Participants who received placebo matched to dupilumab in the parent study EFC14153 received dupilumab for 52 weeks in the main study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
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| Secondary | Japan Sub-study: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 64 | FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 milliliter per second. FeNO assessment was conducted prior to spirometry and following a fast of ≥1 hour. Baseline was defined as the last available measurement prior to first study treatment dose if participant was treated, or last available value up to enrollment if participant was not exposed to study treatment in the current study. | Safety population included all enrolled participants who took at least 1 dose of study treatment in the current study, regardless of the amount of treatment administered. Only participants with data collected are reported. | Posted | | Mean | Standard Deviation | parts per billion | | Baseline (Day 1) to Week 64 | | | | ID | Title | Description |
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| OG000 | Japan Sub-study: Dupilumab | Participants received dupilumab for 52 weeks in the Japan sub-study as follows:
- 100 mg q2w as an SC injection or 300 mg q4w as an SC injection for participants with body weight ≥15 kg and ≤30 kg.
- 200 mg q2w as an SC injection for participants with body weight >30 kg. Participants also received a 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 as instructed by Investigator.
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