Trial Outcomes & Findings for Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion) (NCT NCT03560466)

Last Updated: 2025-11-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

378 participants

Primary outcome timeframe

From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks

Results posted on

2025-11-21

Participant Flow

The main study was conducted at 70 centers in 17 countries, and the sub-study was conducted at 11 centers in Japan. 365 participants who rolled over from parent study EFC14153 (NCT02948959) were enrolled in the main study and 13 participants (not included in parent study EFC14153) were enrolled in Japan sub-study.

All participants received dupilumab dose based on body weight in the main study and Japan sub-study. As pre-specified in the protocol and statistical analysis plan (SAP), the results are presented by study and treatment group, regardless of the dose regimen.

Participant milestones

Participant milestones
Measure	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 milligrams (mg) once every 2 weeks (q2w) as a subcutaneous (SC) injection or 300 mg once every 4 weeks (q4w) as an SC injection for participants with body weight ≤30 kilograms (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 inhaled corticosteroids (ICS) with a second controller medication (i.e., long-acting beta-2 agonists \[LABA\], long-acting muscarinic antagonists \[LAMA\], leukotriene receptor antagonists \[LTRA\] 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.	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.	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.
Overall Study STARTED	125	240	13
Overall Study COMPLETED	118	228	12
Overall Study NOT COMPLETED	7	12	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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 milligrams (mg) once every 2 weeks (q2w) as a subcutaneous (SC) injection or 300 mg once every 4 weeks (q4w) as an SC injection for participants with body weight ≤30 kilograms (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 inhaled corticosteroids (ICS) with a second controller medication (i.e., long-acting beta-2 agonists \[LABA\], long-acting muscarinic antagonists \[LAMA\], leukotriene receptor antagonists \[LTRA\] 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.	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.	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.
Overall Study Adverse Event	1	2	0
Overall Study Poor Compliance to Protocol	0	2	0
Overall Study Other	6	8	1

Baseline Characteristics

Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Main Study: Placebo-Dupilumab n=125 Participants 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.	Main Study: Dupilumab-Dupilumab n=240 Participants 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.	Japan Sub-study: Dupilumab n=13 Participants 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.	Total n=378 Participants Total of all reporting groups
Age, Continuous	9.9 years STANDARD_DEVIATION 1.6 • n=68 Participants	9.9 years STANDARD_DEVIATION 1.7 • n=76 Participants	9.69 years STANDARD_DEVIATION 1.11 • n=48 Participants	9.89 years STANDARD_DEVIATION 1.62 • n=33 Participants
Sex: Female, Male Female	46 Participants n=68 Participants	85 Participants n=76 Participants	4 Participants n=48 Participants	135 Participants n=33 Participants
Sex: Female, Male Male	79 Participants n=68 Participants	155 Participants n=76 Participants	9 Participants n=48 Participants	243 Participants n=33 Participants
Race/Ethnicity, Customized Caucasian/White	111 Participants n=68 Participants	215 Participants n=76 Participants	0 Participants n=48 Participants	326 Participants n=33 Participants
Race/Ethnicity, Customized Black/of African Descent	6 Participants n=68 Participants	9 Participants n=76 Participants	0 Participants n=48 Participants	15 Participants n=33 Participants
Race/Ethnicity, Customized Asian	0 Participants n=68 Participants	1 Participants n=76 Participants	13 Participants n=48 Participants	14 Participants n=33 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=68 Participants	1 Participants n=76 Participants	0 Participants n=48 Participants	1 Participants n=33 Participants
Race/Ethnicity, Customized Other	8 Participants n=68 Participants	14 Participants n=76 Participants	0 Participants n=48 Participants	22 Participants n=33 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=125 Participants 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.	Main Study: Dupilumab-Dupilumab n=240 Participants 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.	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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)	85 Participants	147 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to Week 12

Population: Intent-to-treat (ITT) population included all participants in the enrolled population in the current study.

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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=13 Participants 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.	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.	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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Japan Sub-study: Change From Baseline to Week 12 in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)	7.08 percent predicted FEV1 Standard Deviation 6.78 • Interval 6.78 to	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=13 Participants 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.	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.	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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Japan Sub-study: Number of Participants With Any Treatment-Emergent Adverse Events	13 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=125 Participants 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.	Main Study: Dupilumab-Dupilumab n=240 Participants 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.	Japan Sub-study: Dupilumab n=13 Participants 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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Annualized Rate of Severe Asthma Exacerbation Events During the 52-Week Treatment Period	0.114 exacerbations per participant-years	0.120 exacerbations per participant-years	0.462 exacerbations per participant-years	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64

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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=122 Participants 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.	Main Study: Dupilumab-Dupilumab n=231 Participants 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.	Japan Sub-study: Dupilumab n=13 Participants 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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time Week 8	7.93 percent predicted FEV1 Standard Deviation 14.88	12.47 percent predicted FEV1 Standard Deviation 18.60	6.31 percent predicted FEV1 Standard Deviation 8.97	—	—	—
Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time Week 2	8.06 percent predicted FEV1 Standard Deviation 15.71	11.03 percent predicted FEV1 Standard Deviation 18.74	7.50 percent predicted FEV1 Standard Deviation 9.29	—	—	—
Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time Week 4	—	—	7.00 percent predicted FEV1 Standard Deviation 7.12	—	—	—
Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time Week 12	8.31 percent predicted FEV1 Standard Deviation 14.70	10.95 percent predicted FEV1 Standard Deviation 17.33	7.08 percent predicted FEV1 Standard Deviation 6.78	—	—	—
Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time Week 24	8.37 percent predicted FEV1 Standard Deviation 15.48	11.23 percent predicted FEV1 Standard Deviation 18.24	4.08 percent predicted FEV1 Standard Deviation 8.75	—	—	—
Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time Week 52	8.81 percent predicted FEV1 Standard Deviation 16.18	12.19 percent predicted FEV1 Standard Deviation 17.88	6.73 percent predicted FEV1 Standard Deviation 8.09	—	—	—
Change From Baseline in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second Over Time Week 64	7.98 percent predicted FEV1 Standard Deviation 17.14	10.67 percent predicted FEV1 Standard Deviation 17.19	1.17 percent predicted FEV1 Standard Deviation 8.03	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=122 Participants 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.	Main Study: Dupilumab-Dupilumab n=231 Participants 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.	Japan Sub-study: Dupilumab n=13 Participants 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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Change From Baseline in Absolute Forced Expiratory Volume in 1 Second Over Time Week 2	0.36 liter Standard Deviation 0.32	0.42 liter Standard Deviation 0.38	0.13 liter Standard Deviation 0.15	—	—	—
Change From Baseline in Absolute Forced Expiratory Volume in 1 Second Over Time Week 4	—	—	0.13 liter Standard Deviation 0.13	—	—	—
Change From Baseline in Absolute Forced Expiratory Volume in 1 Second Over Time Week 8	0.38 liter Standard Deviation 0.32	0.47 liter Standard Deviation 0.39	0.12 liter Standard Deviation 0.15	—	—	—
Change From Baseline in Absolute Forced Expiratory Volume in 1 Second Over Time Week 12	0.41 liter Standard Deviation 0.31	0.45 liter Standard Deviation 0.36	0.17 liter Standard Deviation 0.13	—	—	—
Change From Baseline in Absolute Forced Expiratory Volume in 1 Second Over Time Week 24	0.46 liter Standard Deviation 0.35	0.51 liter Standard Deviation 0.39	0.15 liter Standard Deviation 0.15	—	—	—
Change From Baseline in Absolute Forced Expiratory Volume in 1 Second Over Time Week 52	0.62 liter Standard Deviation 0.41	0.66 liter Standard Deviation 0.41	0.34 liter Standard Deviation 0.21	—	—	—
Change From Baseline in Absolute Forced Expiratory Volume in 1 Second Over Time Week 64	0.66 liter Standard Deviation 0.45	0.70 liter Standard Deviation 0.44	0.25 liter Standard Deviation 0.14	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64

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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=122 Participants 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.	Main Study: Dupilumab-Dupilumab n=231 Participants 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.	Japan Sub-study: Dupilumab n=13 Participants 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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Change From Baseline in Forced Vital Capacity (FVC) Over Time Week 4	—	—	0.09 liter Standard Deviation 0.12	—	—	—
Change From Baseline in Forced Vital Capacity (FVC) Over Time Week 24	0.47 liter Standard Deviation 0.36	0.50 liter Standard Deviation 0.40	0.17 liter Standard Deviation 0.15	—	—	—
Change From Baseline in Forced Vital Capacity (FVC) Over Time Week 2	0.35 liter Standard Deviation 0.29	0.38 liter Standard Deviation 0.38	0.11 liter Standard Deviation 0.15	—	—	—
Change From Baseline in Forced Vital Capacity (FVC) Over Time Week 8	0.37 liter Standard Deviation 0.30	0.45 liter Standard Deviation 0.42	0.11 liter Standard Deviation 0.14	—	—	—
Change From Baseline in Forced Vital Capacity (FVC) Over Time Week 12	0.40 liter Standard Deviation 0.30	0.43 liter Standard Deviation 0.39	0.12 liter Standard Deviation 0.11	—	—	—
Change From Baseline in Forced Vital Capacity (FVC) Over Time Week 52	0.68 liter Standard Deviation 0.42	0.70 liter Standard Deviation 0.45	0.36 liter Standard Deviation 0.22	—	—	—
Change From Baseline in Forced Vital Capacity (FVC) Over Time Week 64	0.74 liter Standard Deviation 0.49	0.75 liter Standard Deviation 0.48	0.41 liter Standard Deviation 0.24	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4 (Japan sub-study), 8, 12, 24, 52 and 64

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=122 Participants 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.	Main Study: Dupilumab-Dupilumab n=231 Participants 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.	Japan Sub-study: Dupilumab n=13 Participants 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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Change From Baseline in Forced Expiratory Flow [FEF] 25% to 75% Over Time Week 52	0.73 liter per second Standard Deviation 0.75	0.77 liter per second Standard Deviation 0.67	0.40 liter per second Standard Deviation 0.46	—	—	—
Change From Baseline in Forced Expiratory Flow [FEF] 25% to 75% Over Time Week 2	0.49 liter per second Standard Deviation 0.63	0.58 liter per second Standard Deviation 0.66	0.21 liter per second Standard Deviation 0.26	—	—	—
Change From Baseline in Forced Expiratory Flow [FEF] 25% to 75% Over Time Week 4	—	—	0.25 liter per second Standard Deviation 0.23	—	—	—
Change From Baseline in Forced Expiratory Flow [FEF] 25% to 75% Over Time Week 8	0.48 liter per second Standard Deviation 0.60	0.62 liter per second Standard Deviation 0.63	0.15 liter per second Standard Deviation 0.30	—	—	—
Change From Baseline in Forced Expiratory Flow [FEF] 25% to 75% Over Time Week 12	0.54 liter per second Standard Deviation 0.60	0.59 liter per second Standard Deviation 0.61	0.29 liter per second Standard Deviation 0.31	—	—	—
Change From Baseline in Forced Expiratory Flow [FEF] 25% to 75% Over Time Week 24	0.58 liter per second Standard Deviation 0.68	0.66 liter per second Standard Deviation 0.65	0.15 liter per second Standard Deviation 0.37	—	—	—
Change From Baseline in Forced Expiratory Flow [FEF] 25% to 75% Over Time Week 64	0.77 liter per second Standard Deviation 0.78	0.79 liter per second Standard Deviation 0.70	0.11 liter per second Standard Deviation 0.34	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 8, 12, 24, 52 and 64

Population: 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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=122 Participants 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.	Main Study: Dupilumab-Dupilumab n=231 Participants 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.	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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity Over Time Week 64	3.13 percent predicted FVC Standard Deviation 15.14	4.83 percent predicted FVC Standard Deviation 16.09	—	—	—	—
Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity Over Time Week 2	2.98 percent predicted FVC Standard Deviation 12.91	5.02 percent predicted FVC Standard Deviation 16.33	—	—	—	—
Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity Over Time Week 8	2.88 percent predicted FVC Standard Deviation 12.17	6.64 percent predicted FVC Standard Deviation 17.42	—	—	—	—
Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity Over Time Week 12	3.23 percent predicted FVC Standard Deviation 12.49	5.03 percent predicted FVC Standard Deviation 16.45	—	—	—	—
Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity Over Time Week 24	3.19 percent predicted FVC Standard Deviation 13.35	5.28 percent predicted FVC Standard Deviation 16.20	—	—	—	—
Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity Over Time Week 52	3.74 percent predicted FVC Standard Deviation 13.10	6.43 percent predicted FVC Standard Deviation 16.40	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64

Population: ITT population included all participants in enrolled population in current study. Only participants with data collected at specified timepoints are reported

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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=13 Participants 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.	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.	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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time Week 2	-0.65 score on a scale Standard Deviation 0.64	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time Week 4	-0.68 score on a scale Standard Deviation 0.75	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time Week 8	-0.84 score on a scale Standard Deviation 0.59	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time Week 12	-1.03 score on a scale Standard Deviation 0.66	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time Week 24	-0.96 score on a scale Standard Deviation 0.61	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time Week 36	-1.01 score on a scale Standard Deviation 0.47	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time Week 52	-1.21 score on a scale Standard Deviation 0.37	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 7-Question Version (ACQ-7-IA) Over Time Week 64	-0.99 score on a scale Standard Deviation 0.52	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 52 and 64

Population: ITT population included all participants in enrolled population in current study. Only participants with data collected at specified timepoints are reported

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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=13 Participants 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.	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.	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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time Week 2	-0.68 score on a scale Standard Deviation 0.87	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time Week 4	-0.75 score on a scale Standard Deviation 1.06	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time Week 8	-0.92 score on a scale Standard Deviation 0.82	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time Week 12	-1.20 score on a scale Standard Deviation 0.84	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time Week 24	-1.15 score on a scale Standard Deviation 0.68	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time Week 36	-1.25 score on a scale Standard Deviation 0.54	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time Week 52	-1.49 score on a scale Standard Deviation 0.54	—	—	—	—	—
Japan Sub-study: Change From Baseline in Asthma Control Questionnaire-Interviewer Administered, 5-Question Version (ACQ-5-IA) Over Time Week 64	-1.28 score on a scale Standard Deviation 0.59	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52 and 64

Population: 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.

Blood samples were collected at the specified timepoints for determination of functional dupilumab concentration in serum.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=52 Participants 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.	Main Study: Dupilumab-Dupilumab n=299 Participants 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.	Japan Sub-study: Dupilumab n=16 Participants 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.	Japan Sub-study: Dupilumab 100 mg q2w n=3 Participants All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w n=7 Participants All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w n=3 Participants All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Serum Concentrations of Dupilumab Week 64	1884.04 nanogram per milliliter Standard Deviation 9763.01	3391.86 nanogram per milliliter Standard Deviation 16196.36	184.69 nanogram per milliliter Standard Deviation 582.75	39.00 nanogram per milliliter Standard Deviation 0.00	39.00 nanogram per milliliter Standard Deviation 0.00	39.00 nanogram per milliliter Standard Deviation 0.00
Serum Concentrations of Dupilumab Week 52	52808.85 nanogram per milliliter Standard Deviation 21526.05	71910.74 nanogram per milliliter Standard Deviation 42290.54	81289.94 nanogram per milliliter Standard Deviation 31957.07	41000.00 nanogram per milliliter Standard Deviation 23157.94	91128.57 nanogram per milliliter Standard Deviation 28739.33	59300.00 nanogram per milliliter Standard Deviation 18107.46
Serum Concentrations of Dupilumab Week 12	60740.38 nanogram per milliliter Standard Deviation 23885.77	80450.15 nanogram per milliliter Standard Deviation 39865.24	79600.00 nanogram per milliliter Standard Deviation 25509.84	38600.00 nanogram per milliliter Standard Deviation 20850.18	79128.57 nanogram per milliliter Standard Deviation 24513.31	53066.67 nanogram per milliliter Standard Deviation 18569.96
Serum Concentrations of Dupilumab Week 24	64201.03 nanogram per milliliter Standard Deviation 22890.02	81849.66 nanogram per milliliter Standard Deviation 42824.93	80675.00 nanogram per milliliter Standard Deviation 26921.27	41300.00 nanogram per milliliter Standard Deviation 22138.65	98316.67 nanogram per milliliter Standard Deviation 18066.81	55166.67 nanogram per milliliter Standard Deviation 14558.96

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) to Week 64

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=124 Participants 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.	Main Study: Dupilumab-Dupilumab n=239 Participants 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.	Japan Sub-study: Dupilumab n=13 Participants 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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Number of Participants With Anti-Drug Antibodies (ADAs) Against Dupilumab Treatment-boosted ADA Response	1 Participants	0 Participants	—	—	—	—
Number of Participants With Anti-Drug Antibodies (ADAs) Against Dupilumab Treatment-emergent ADA Response	10 Participants	7 Participants	2 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 64

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=103 Participants 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.	Main Study: Dupilumab-Dupilumab n=186 Participants 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.	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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Main Study: Percent Change From Baseline in Blood Eosinophil Count at Week 64	34.528 percent change Standard Deviation 207.067 • Interval 207.067 to	29.769 percent change Standard Deviation 323.837 • Interval 323.837 to	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 64

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=113 Participants 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.	Main Study: Dupilumab-Dupilumab n=219 Participants 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.	Japan Sub-study: Dupilumab n=12 Participants 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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Percent Change From Baseline in Total Immunoglobulin (Ig) E in Serum at Week 64	-76.9 percent change Inter-Quartile Range -85.2 • Interval -85.2 to -63.4	-86.8 percent change Inter-Quartile Range -91.4 • Interval -91.4 to -77.3	-75.0 percent change Inter-Quartile Range -81.1 • Interval -81.1 to -70.0	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 64

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Main Study: Placebo-Dupilumab n=12 Participants 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.	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.	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.	Japan Sub-study: Dupilumab 100 mg q2w All participants from the Japan sub-study who received dupilumab 100 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 200 mg q2w All participants from the Japan sub-study who received dupilumab 200 mg q2w were included in this arm.	Japan Sub-study: Dupilumab 300 mg q4w All participants from the Japan sub-study who received dupilumab 300 mg q4w were included in this arm.
Japan Sub-study: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 64	-8.3 parts per billion Standard Deviation 27.5 • Interval 27.5 to	—	—	—	—	—

Adverse Events

Main Study: Placebo-Dupilumab

Serious events: 1 serious events

Other events: 63 other events

Deaths: 0 deaths

Main Study: Dupilumab-Dupilumab

Serious events: 6 serious events

Other events: 108 other events

Deaths: 0 deaths

Japan Sub-study: Dupilumab

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Main Study: Placebo-Dupilumab n=125 participants at risk 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.	Main Study: Dupilumab-Dupilumab n=240 participants at risk 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.	Japan Sub-study: Dupilumab n=13 participants at risk 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.
Gastrointestinal disorders Constipation	0.00% 0/125 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.42% 1/240 • Number of events 1 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.00% 0/13 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.
Infections and infestations Bronchitis	0.00% 0/125 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.00% 0/240 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	7.7% 1/13 • Number of events 1 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.
Infections and infestations Complicated Appendicitis	0.00% 0/125 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.42% 1/240 • Number of events 1 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.00% 0/13 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.
Infections and infestations Influenza	0.00% 0/125 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.00% 0/240 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	7.7% 1/13 • Number of events 2 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.
Infections and infestations Pneumonia	0.80% 1/125 • Number of events 1 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.00% 0/240 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.00% 0/13 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.
Infections and infestations Pulmonary Tuberculosis	0.00% 0/125 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.42% 1/240 • Number of events 1 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.00% 0/13 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/125 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.42% 1/240 • Number of events 1 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.00% 0/13 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/125 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.42% 1/240 • Number of events 1 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.00% 0/13 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/125 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.00% 0/240 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	15.4% 2/13 • Number of events 5 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/125 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.42% 1/240 • Number of events 1 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.	0.00% 0/13 • AEs: From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks for main study and sub-study each. Deaths: From first dose of study treatment (Day 1) up to end of follow-up, approximately 353 weeks. Analysis was performed on safety population. As pre-specified in the protocol and SAP, the results are presented by study and treatment group, regardless of the dose regimen.

Other adverse events

Additional Information

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