Trial Outcomes & Findings for Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE) (NCT NCT04394351)

Last Updated: 2025-10-27

Results Overview

Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quantities of eosinophils from the region(s) where eosinophil quantities were available.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

102 participants

Primary outcome timeframe

At Week 16

Results posted on

2025-10-27

Participant Flow

This study consisted of 3 parts: Part A (double-blind 16-week treatment period), Part B (36-week extended active treatment period) and Part C (open-label extension period of up to 108 weeks).

Participant milestones

Participant milestones
Measure	Part A: Pooled Placebo (Placebo) Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part B: Placebo to Dupilumab Low Dose Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W	Part B: Placebo to Dupilumab High Dose Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part B: Dupilumab Low Dose to Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part C: Dupilumab Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment
Part A (16 Weeks) STARTED	34	31	37	0	0	0	0	0
Part A (16 Weeks) COMPLETED	33	29	37	0	0	0	0	0
Part A (16 Weeks) NOT COMPLETED	1	2	0	0	0	0	0	0
Part B (36 Weeks) STARTED	0	0	0	14	18	29	37	0
Part B (36 Weeks) COMPLETED	0	0	0	14	18	29	36	0
Part B (36 Weeks) NOT COMPLETED	0	0	0	0	0	0	1	0
Part C: (Up to Wk108+12Wk Follow-up) STARTED	0	0	0	0	0	0	0	61
Part C: (Up to Wk108+12Wk Follow-up) COMPLETED	0	0	0	0	0	0	0	8
Part C: (Up to Wk108+12Wk Follow-up) NOT COMPLETED	0	0	0	0	0	0	0	53

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Pooled Placebo (Placebo) Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part C: Dupilumab Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment
Part A (16 Weeks) Adverse Event	1	0	0	0
Part A (16 Weeks) Physician Decision	0	1	0	0
Part A (16 Weeks) Withdrawal by Subject	0	1	0	0
Part B (36 Weeks) Adverse Event	0	0	1	0
Part C: (Up to Wk108+12Wk Follow-up) Physician Decision	0	0	0	3
Part C: (Up to Wk108+12Wk Follow-up) Withdrawal by Subject	0	0	0	16
Part C: (Up to Wk108+12Wk Follow-up) Protocol Violation	0	0	0	2
Part C: (Up to Wk108+12Wk Follow-up) Other	0	0	0	32

Baseline Characteristics

Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Pooled Placebo n=34 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab Low Dose n=31 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W	Part A: Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Total n=102 Participants Total of all reporting groups
Age, Continuous	7.2 years STANDARD_DEVIATION 3.03 • n=5 Participants	7.2 years STANDARD_DEVIATION 3.07 • n=7 Participants	6.8 years STANDARD_DEVIATION 3.11 • n=5 Participants	7.1 years STANDARD_DEVIATION 3.05 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	28 Participants n=5 Participants	78 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	29 Participants n=7 Participants	33 Participants n=5 Participants	92 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized White	30 Participants n=5 Participants	22 Participants n=7 Participants	32 Participants n=5 Participants	84 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Week 16

Population: Analysis was performed on Part A FAS which included all randomized participants in Part A.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=34 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=31 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of Less Than or Equal to (≤) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16	2.9 percentage of participants Interval 0.07 to 15.33	67.6 percentage of participants Interval 50.21 to 81.99	58.1 percentage of participants Interval 39.08 to 75.45	—

SECONDARY outcome

Timeframe: At Week 16

Population: Analysis was performed on Part A FAS which included all randomized participants in Part A.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=34 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=31 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eosinophils/High Power Field at Week 16	2.9 percentage of participants Interval 0.07 to 15.33	83.8 percentage of participants Interval 67.99 to 93.81	67.7 percentage of participants Interval 48.63 to 83.32	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on Part A FAS which included all randomized participants in Part A.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=34 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=31 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count at Week 16	20.98 percent change Standard Error 12.23	-86.09 percent change Standard Error 11.84	-77.93 percent change Standard Error 12.89	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on Part A FAS which included all randomized participants in Part A.

EoE-HSS is a validated histologic scoring system that measures other histological abnormalities in addition to density of eosinophilic infiltration. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change). Higher total score indicated greater severity \& extent of histological abnormalities. For each of 3 esophageal regions (proximal, mid, and distal), the ratio of the sum of assigned score for each evaluated feature divided by maximum possible score (maximum value is 24) was calculated. The mean grade scores summed over the 3 regions was the final score used in primary analysis, the mean grade score ranged from 0 to 3, with higher score indicating more severe.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=34 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=31 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) Grade Score at Week 16	0.023 Score on a scale Standard Error 0.0498	-0.879 Score on a scale Standard Error 0.0481	-0.757 Score on a scale Standard Error 0.0524	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on Part A FAS which included all randomized participants in Part A.

EoE-HSS is a validated histologic scoring system that measures other histological abnormalities in addition to density of eosinophilic infiltration. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change). Higher total score indicated greater severity \& extent of histological abnormalities. For each of 3 esophageal regions (proximal, mid, and distal), the ratio of the sum of assigned score for each evaluated feature divided by maximum possible score (maximum value is 24) was calculated. The mean stage scores summed over the 3 regions was the final score used in primary analysis, the mean stage score ranged from 0 to 3, with higher score indicating more severe.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=34 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=31 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) Stage Score at Week 16	0.048 Score on a scale Standard Error 0.0482	-0.835 Score on a scale Standard Error 0.0466	-0.721 Score on a scale Standard Error 0.0507	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on Part A FAS which included all randomized participants in Part A. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for T2INF reflect the expression at Week 16 relative to Baseline of the pre-specified gene set as a way to evaluate normalization of type 2 inflammation with treatment. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have a minimum/maximum score.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=21 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=24 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=15 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Normalized Enrichment Score (NES) for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 16	0.34 Score on a scale Interval -1.84 to 1.65	-1.895 Score on a scale Interval -2.03 to -1.61	-1.930 Score on a scale Interval -2.0 to -1.39	—

SECONDARY outcome

Timeframe: Baseline, Week 16

A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for the EDP reflect the expression at Week 16 relative to Baseline of a gene set that is differentially expressed between esophageal biopsies from EoE participants compared to healthy controls as a way to evaluate normalization of the molecular pathology. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=21 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=24 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=15 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Normalized Enrichment Score (NES) for the Relative Change From Baseline in the Eosinophilic Esophagitis (EoE) Diagnostic Panel (EDP) at Week 16	0.180 Score on a scale Interval -2.53 to 2.39	-2.630 Score on a scale Interval -2.85 to -2.25	-2.710 Score on a scale Interval -2.84 to -0.8	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on Part A FAS which included all randomized participants in Part A.

The EoE-EREFS is a validated endoscopic scoring system for inflammatory and remodeling features of EoE including edema, rings, exudates, furrows, and stricture. The score was assessed in the proximal and distal esophageal regions with each region scored from 0 to 9 with total scores ranging from 0 to 18. Higher scores indicate worse endoscopic inflammatory and remodeling findings.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=34 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=31 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 16	0.3 score on a scale Standard Error 0.45	-3.5 score on a scale Standard Error 0.42	-3.0 score on a scale Standard Error 0.48	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on Part A FAS which included all randomized participants in Part A.

PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study. PESQ-C measures the signs of EoE observed by the caregiver, including stomach pain, heartburn, acid reflux, regurgitation, vomiting, food refusal, and trouble swallowing food. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the proportion of days with 1 or more EoE symptoms.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=34 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=31 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Change From Baseline in the Proportion of Days With 1 or More EoE Signs as Measured by Pediatric EoE Sign/Symptom Questionnaire - Caregiver Version (PESQ-C) at Week 16 (for Participants Aged ≥1 to <12 Years)	-0.17 proportion of days Standard Error 0.054	-0.28 proportion of days Standard Error 0.052	-0.18 proportion of days Standard Error 0.060	—

SECONDARY outcome

Timeframe: Week 16

Population: Analysis was performed on Part A FAS which included all randomized participants in Part A.

PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study. The PESQ-C measures the signs of EoE observed by the caregiver, including stomach pain, heartburn, acid reflux, regurgitation, vomiting, food refusal, and trouble swallowing food. WOCF approach was used for imputing the missing data due to rescue treatment/AE/lack of efficacy, and the multiple imputations approach was used for the missing data due to other reasons. LS mean SE derived from ANCOVA model.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=34 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=31 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Number of Sign-free Days During the 14-day Period Preceding Week 16 as Measured by the PESQ-C (for Participants Aged ≥1 to <12 Years)	8.93 sign-free days Standard Error 0.756	10.38 sign-free days Standard Error 0.735	8.93 sign-free days Standard Error 0.840	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on Part A FAS which included all randomized participants in Part A.

PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study. The PESQ-C measured the occurrence of signs of EoE and was completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the total time segments within a day (night, morning, afternoon, evening) with 1 or more EoE symptoms.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=34 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=31 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Change From Baseline in the Proportion of Total Segments Within a Day (Night, Morning, Afternoon, Evening) With 1 or More EoE Signs as Measured by the PESQ-C at Week 16	-0.11 proportion of segments Standard Error 0.032	-0.16 proportion of segments Standard Error 0.031	-0.09 proportion of segments Standard Error 0.036	—

SECONDARY outcome

Timeframe: Baseline, Week 16

The PESQ-P was a participant-reported outcome measure intended to be completed independently by participants ≥8 to \<12 years of age. The PESQ-P measured occurrence of signs of EoE and was completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the proportion of days with 1 or more EoE symptoms.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=17 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=17 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=19 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Change From Baseline in the Proportion of Days With 1 or More EoE Signs by Pediatric EoE Sign/Symptom Questionnaire - Participant Version (PESQ-P) (for Participants Aged ≥8 to <12 Years) at Week 16	-0.26 proportion of days Standard Error 0.068	-0.13 proportion of days Standard Error 0.077	-0.16 proportion of days Standard Error 0.067	—

SECONDARY outcome

Timeframe: Week 16

The PESQ-P was a participant-reported outcome measure intended to be completed independently by EoE participants ≥8 to \<12 years of age. The PESQ-P measures the signs of EoE, including stomach pain, heartburn, acid reflux, regurgitation, vomiting, food refusal, and trouble swallowing food. The PESQ-P score was calculated based on the daily responses over a 14-day period (i.e., the 14 days prior to the baseline visit and the week 16 visit). The score ranges from 0 to 1. WOCF approach was used for imputing the missing data due to rescue treatment/AE/lack of efficacy, and the multiple imputations approach was used for the missing data due to other reasons. LS Mean SE from ANCOVA.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=17 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=17 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=19 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Number of Symptom-free Days During the 14-day Period Preceding Week 16 as Measured by the PESQ-P (for Participants Aged ≥8 to <12 Years)	10.49 sign-free days Standard Error 0.953	8.69 sign-free days Standard Error 1.081	9.13 sign-free days Standard Error 0.936	—

SECONDARY outcome

Timeframe: Baseline, Week 16

The PESQ-P was a participant-reported outcome measure intended to be completed independently by EoE participants ≥8 to \<12 years of age. The PESQ-P measured the occurrence of signs of EoE and was completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding week 16 will be used to calculate the total time segments within a day (night, morning, afternoon, evening) with 1 or more EoE symptoms.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=17 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=17 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=19 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Change From Baseline in the Proportion of Total Segments Within a Day (Night, Morning, Afternoon, Evening) With 1 or More EoE Signs as Measured by the PESQ-P (for Participants Aged ≥8 to <12 Years) at Week 16	-0.15 proportion of segments Standard Error 0.040	-0.08 proportion of segments Standard Error 0.045	-0.08 proportion of segments Standard Error 0.039	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on Part A FAS which included all randomized participants in Part A.

The PEESSv2.0-C is a caregiver-reported outcome measure that assesses the frequency and severity of EoE symptoms among pediatric participants. The PEESSv2.0-C consists of 20 items and has a one-month recall period. Each item had a 0-4 scale, which was transformed to 0-100 as follows: 0 = 0, 1 = 25, 2 = 50, 3 = 75, 4 = 100. The mean total PEESSv2.0 score was computed as the sum of all the item scores over the number of items answered. The total PEESSv2.0-C score ranges from 0 to 100 where higher scores indicate greater symptom burden among pediatric EoE participants. Values after first rescue treatment use were set to missing (censoring). WOCF approach was used for imputing the missing data due to rescue treatment/AE/lack of efficacy, and the MI approach was used for the missing data due to other reasons. LS mean SE from ANCOVA model.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=34 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=31 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Change From Baseline in Total Score as Measured by the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS) Version 2.0 Caregiver Version (PEESSv2.0-C) at Week 16	-11.83 score on a scale Standard Error 2.909	-19.86 score on a scale Standard Error 2.577	-10.10 score on a scale Standard Error 2.785	—

SECONDARY outcome

Timeframe: Baseline, Week 4 and 16

Population: Analysis was performed on pharmacokinetic analysis set (PKAS) that includes all participants who received any study drug and had at least 1 non-missing result following the first dose of study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.

Concentration of functional dupilumab in serum at Baseline, Week 4 and 16 was reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=36 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=28 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Concentration of Functional Dupilumab in Serum at Baseline, Week 4 and 16 Week 16	163 milligrams per liter (mg/L) Standard Deviation 60.8	86.0 milligrams per liter (mg/L) Standard Deviation 29.2	—	—
Part A: Concentration of Functional Dupilumab in Serum at Baseline, Week 4 and 16 Baseline	0 milligrams per liter (mg/L) Standard Deviation 0	0 milligrams per liter (mg/L) Standard Deviation 0	—	—
Part A: Concentration of Functional Dupilumab in Serum at Baseline, Week 4 and 16 Week 4	75.7 milligrams per liter (mg/L) Standard Deviation 25.7	40.6 milligrams per liter (mg/L) Standard Deviation 11.2	—	—

SECONDARY outcome

Timeframe: At Week 52

Population: Analysis was performed on Part B safety analysis set (SAF) which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=14 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=17 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=29 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=35 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils/High Power Field at Week 52	92.9 percentage of participants	52.9 percentage of participants	65.5 percentage of participants	62.9 percentage of participants

SECONDARY outcome

Timeframe: At Week 52

Population: Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=14 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=17 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=29 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=35 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eosinophils/High Power Field at Week 52	92.9 percentage of participants	64.7 percentage of participants	69.0 percentage of participants	85.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 52

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=14 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=17 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=29 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=35 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count at Week 52	-92.72 percent change Standard Deviation 19.229	-76.83 percent change Standard Deviation 41.228	-85.41 percent change Standard Deviation 22.851	-90.97 percent change Standard Deviation 14.482

SECONDARY outcome

Timeframe: Baseline, Week 52

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=14 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=17 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=29 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=35 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) Grade Score at Week 52	-0.804 Score on a scale Standard Deviation 0.3099	-0.885 Score on a scale Standard Deviation 0.2962	-0.773 Score on a scale Standard Deviation 0.3374	-0.967 Score on a scale Standard Deviation 0.3920

SECONDARY outcome

Timeframe: Baseline, Week 52

EoE-HSS is a validated histologic scoring system that measures other histological abnormalities in addition to density of eosinophilic infiltration. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change). Higher total score indicated greater severity \& extent of histological abnormalities. For each of 3 esophageal regions (proximal, mid, and distal), the ratio of the sum of assigned score for each evaluated feature divided by maximum possible score (maximum value is 24) was calculated. The mean stage scores summed over the 3 regions was the final score used in primary analysis, the mean stage score ranged from 0 to 3, with higher score indicating more severe.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=14 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=17 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=29 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=35 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Change From Baseline in Mean Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) Stage Score at Week 52	-0.767 Score on a scale Standard Deviation 0.3114	-0.855 Score on a scale Standard Deviation 0.3485	-0.784 Score on a scale Standard Deviation 0.3183	-0.892 Score on a scale Standard Deviation 0.3181

SECONDARY outcome

Timeframe: Baseline, Week 52

The EoE-EREFS is a validated endoscopic scoring system for inflammatory and remodeling features of EoE including edema, rings, exudates, furrows, and stricture. The score was assessed in the proximal and distal esophageal regions with each region scored from 0 to 9 with total scores possibly ranging from 0 to 18. Higher scores indicate worse endoscopic inflammatory and remodeling findings.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=11 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=14 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=22 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=30 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 52	-5.82 score on a scale Standard Deviation 1.722	-3.64 score on a scale Standard Deviation 3.342	-4.50 score on a scale Standard Deviation 3.203	-4.77 score on a scale Standard Deviation 3.081

SECONDARY outcome

Timeframe: Baseline, Week 52

PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=6 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=9 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=18 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=27 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Change From Baseline in the Proportion of Days With 1 or More EoE Signs Measured by Pediatric EoE Sign/Symptom Questionnaire - Caregiver Version (PESQ-C) at Week 52	-0.20 proportion of days Standard Deviation 0.373	-0.47 proportion of days Standard Deviation 0.395	-0.49 proportion of days Standard Deviation 0.339	-0.30 proportion of days Standard Deviation 0.299

SECONDARY outcome

Timeframe: Week 52

PESQ-C is a novel, observer-reported outcome measure intended to be completed independently by caregivers of all pediatric EoE participants in the study.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=6 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=9 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=18 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=27 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Number of Sign-free Days During the 14-day Period Preceding Week 52 as Measured by the PESQ-C (for Participants Aged ≥1 to <12 Years)	11.58 sign-free days Standard Deviation 3.968	12.10 sign-free days Standard Deviation 4.652	11.35 sign-free days Standard Deviation 3.947	12.13 sign-free days Standard Deviation 4.053

SECONDARY outcome

Timeframe: Baseline, Week 52

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=6 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=9 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=18 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=27 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Change From Baseline in the Proportion of Total Segments Within a Day (Night, Morning, Afternoon, Evening) With 1 or More EoE Signs as Measured by the PESQ-C at Week 52	-0.03 proportion of segments Standard Deviation 0.249	-0.24 proportion of segments Standard Deviation 0.221	-0.26 proportion of segments Standard Deviation 0.250	-0.17 proportion of segments Standard Deviation 0.187

SECONDARY outcome

Timeframe: Baseline, Week 52

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=3 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=6 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=11 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=12 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Change From Baseline in the Proportion of Days With 1 or More EoE Signs by Pediatric EoE Sign/Symptom Questionnaire - Participant Version (PESQ-P) (for Participants Aged ≥8 to <12 Years) at Week 52	-0.33 proportion of days Standard Deviation 0.322	-0.43 proportion of days Standard Deviation 0.369	-0.42 proportion of days Standard Deviation 0.400	-0.26 proportion of days Standard Deviation 0.396

SECONDARY outcome

Timeframe: Week 52

The PESQ-P was a participant-reported outcome measure intended to be completed independently by participants ≥8 to \<12 years of age. The PESQ-P measures the signs of EoE, including stomach pain, heartburn, acid reflux, regurgitation, vomiting, food refusal, and trouble swallowing food.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=3 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=6 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=11 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=12 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Number of Symptom-free Days During the 14-day Period Preceding Week 52 as Measured by the PESQ-P (for Participants Aged ≥8 to <12 Years)	9.33 sign-free days Standard Deviation 8.083	11.67 sign-free days Standard Deviation 5.715	10.64 sign-free days Standard Deviation 4.943	13.63 sign-free days Standard Deviation 0.874

SECONDARY outcome

Timeframe: Baseline, Week 52

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=3 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=6 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=11 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=12 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Change From Baseline in the Proportion of Total Segments Within a Day (Night, Morning, Afternoon, Evening) With 1 or More EoE Signs as Measured by the PESQ-P (for Participants Aged ≥8 to <12 Years) at Week 52	-0.17 proportion of segments Standard Deviation 0.164	-0.26 proportion of segments Standard Deviation 0.269	-0.21 proportion of segments Standard Deviation 0.293	-0.16 proportion of segments Standard Deviation 0.284

SECONDARY outcome

Timeframe: Baseline, Week 52

A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for the EDP reflect the expression at post-baseline relative to Baseline of a gene set that is differentially expressed between esophageal biopsies from EoE participants compared to healthy controls as a way to evaluate normalization of the molecular pathology. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=8 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=12 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=16 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=21 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Normalized Enrichment Score (NES) for the Relative Change From Baseline in the EoE Diagnostic Panel (EDP) at Week 52	-2.715 Score on a scale Interval -2.755 to -2.505	-2.615 Score on a scale Interval -2.81 to -2.43	-2.625 Score on a scale Interval -2.775 to -2.55	-2.670 Score on a scale Interval -2.71 to -2.53

SECONDARY outcome

Timeframe: Baseline, Week 52

A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for T2INF reflect the expression at post-baseline relative to Baseline of the pre-specified gene set as a way to evaluate normalization of type 2 inflammation with treatment. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=8 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=12 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=16 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=21 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Normalized Enrichment Score (NES) for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 52	-1.960 Score on a scale Interval -2.0 to -1.895	-1.965 Score on a scale Interval -1.995 to -1.765	-1.920 Score on a scale Interval -1.965 to -1.865	-1.920 Score on a scale Interval -1.93 to -1.85

SECONDARY outcome

Timeframe: Baseline, Week 52

Body weight for age percentile was calculated based on the growth charts from the Centers for Disease Control and Prevention (CDC) for ages 0 to 20 years (for ages 2 to \<12 years) and World Health Organization (WHO) growth charts for ages 0 to \<2 years (for ages 1 to \<2 years). These charts included a set of smoothed percentiles along with CDC LMS (Lambda-Mu-Sigma) parameters to allow the calculation of percentiles.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=14 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=16 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=29 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=35 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Change From Baseline in Body Weight for Age Percentile at Week 52	-0.02 Percentile Standard Deviation 13.893	5.48 Percentile Standard Deviation 12.644	4.75 Percentile Standard Deviation 11.968	5.96 Percentile Standard Deviation 11.519

SECONDARY outcome

Timeframe: Baseline, Week 52

BMI for age z-score indicates how much higher or lower a participant's BMI for age is relative to a reference growth chart (based on the growth charts from Centers for Disease Control and Prevention \[CDC\] for ages 0 to 20 years \[for ages 2 to \<12 years\]). A z-score of "0" represents the population mean. An increase in the mean change in BMI for age z-score (ie, increase in the standard deviation \[SD\] from the reference growth chart) indicates an increase in BMI for age relative to the reference.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=14 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=15 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=27 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=32 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Change From Baseline in Body Mass Index (BMI) for Age Z-score for Participants ≥2 Years of Age at Week 52	-0.0206 z-score Standard Deviation 0.54625	0.0687 z-score Standard Deviation 0.47605	-0.0549 z-score Standard Deviation 0.88582	0.0987 z-score Standard Deviation 0.72329

SECONDARY outcome

Timeframe: Baseline, Week 52

Weight for age z-score indicates how much higher or lower a participant's weight for age is relative to a reference growth chart (based on the growth charts from CDC for ages 0 to 20 years \[for ages 2 to \<12 years\] and World Health Organization (WHO) growth charts for ages 0 to \<2 years \[for ages 1 to \<2 years\]). A z-score of "0" represents the population mean. An increase in the mean change in weight for age z-score (increase in the SD from the reference growth chart) indicates an increase in weight for age relative to the reference.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=14 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=16 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=29 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=35 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Change From Baseline in Weight for Age Z-score at Week 52	0.0640 z-score Standard Deviation 0.46264	0.2016 z-score Standard Deviation 0.39446	0.1445 z-score Standard Deviation 0.40310	0.2049 z-score Standard Deviation 0.40305

SECONDARY outcome

Timeframe: Baseline, Week 52

Weight for height z-score indicates how much higher or lower a participant's weight for height is relative to a reference growth chart (based on the growth charts from CDC for ages 0 to 20 years \[for ages 2 to \<12 years\] and WHO growth charts for ages 0 to \<2 years \[for ages 1 to \<2 years\]). A z-score of "0" represents the population mean. An increase in the mean change in weight for height z-score (increase in the SD from the reference growth chart) indicates an increase in weight for height relative to the reference.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=2 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=3 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=9 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=12 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Change From Baseline in Body Weight From Height Z-score at Week 52	0.0962 z-score Standard Deviation 0.48902	-0.0100 z-score Standard Deviation 0.51706	-0.2700 z-score Standard Deviation 1.04895	-0.0151 z-score Standard Deviation 0.67968

SECONDARY outcome

Timeframe: Week 32 and 52

Population: Analysis was performed on PKAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.

Concentration of functional dupilumab in serum at Week 32 and 52 was reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=14 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=18 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=29 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Concentration of Functional Dupilumab in Serum at Week 32 and 52 Week 32	105 mg/L Standard Deviation 49.8	142 mg/L Standard Deviation 48.5	99.0 mg/L Standard Deviation 42.8	186 mg/L Standard Deviation 59.5
Part B: Concentration of Functional Dupilumab in Serum at Week 32 and 52 Week 52	101 mg/L Standard Deviation 44.3	149 mg/L Standard Deviation 59.1	83.0 mg/L Standard Deviation 33.2	179 mg/L Standard Deviation 75.3

SECONDARY outcome

Timeframe: From Baseline up to Week 16 in Part A

Population: Analysis was performed on Part A SAF which included all randomized patients who received any Part A study drug.

An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious AE was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or a medically important event. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs include both Serious TEAEs and non-serious TEAEs. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=34 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=30 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events of Special Interest (AESIs) and TEAEs Leading to Permanent Discontinuation of Study Drug Participants with any TEAE	31 Participants	27 Participants	26 Participants	—
Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events of Special Interest (AESIs) and TEAEs Leading to Permanent Discontinuation of Study Drug Participants with any Serious TEAE	0 Participants	2 Participants	1 Participants	—
Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events of Special Interest (AESIs) and TEAEs Leading to Permanent Discontinuation of Study Drug Participants with any AESI	1 Participants	2 Participants	1 Participants	—
Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events of Special Interest (AESIs) and TEAEs Leading to Permanent Discontinuation of Study Drug Participants with any TEAE leading to permanent discontinuation of study drug	2 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: From Week 16 up to Week 52 in Part B

Population: Analysis was performed on Part B SAF which included all participants who received at least 1 dose of Part B study drug.

An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious AE was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or a medically important event. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs include both Serious TEAEs and non-serious TEAEs. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=14 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=18 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=29 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events of Special Interest (AESIs) and TEAEs Leading to Permanent Discontinuation of Study Drug Participants with any TEAE	14 Participants	15 Participants	28 Participants	34 Participants
Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events of Special Interest (AESIs) and TEAEs Leading to Permanent Discontinuation of Study Drug Participants with any Serious TEAE	1 Participants	0 Participants	3 Participants	2 Participants
Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events of Special Interest (AESIs) and TEAEs Leading to Permanent Discontinuation of Study Drug Participants with any AESI	0 Participants	1 Participants	3 Participants	4 Participants
Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events of Special Interest (AESIs) and TEAEs Leading to Permanent Discontinuation of Study Drug Participants with any TEAE leading to permanent discontinuation of study drug	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From Baseline up to Week 16 in Part A

Population: Analysis was performed on ADA analysis set (AAS) which included all participants who received any amount of study drug (active or placebo) and had at least one non-missing anti-drug antibody result following the first dose of study drug or placebo. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

Treatment-emergent ADA was defined as a negative result or missing result at baseline with at least one positive post baseline result in the ADA assay. Samples positive in the dupilumab ADA assay were characterized for ADA titers (low, moderate and high). The low treatment-emergent ADA titer as defined as titer level \<1000, moderate as 1000 to 10000 and high as \>10000.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=25 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=31 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=26 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Number of Participants With Positive Treatment-emergent Antidrug Antibodies (ADA) Response	1 Participants	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: From Baseline up to Week 16 in Part A

Population: Analysis was performed on AAS which included all participants who received any amount of study drug (active or placebo) and had at least one non-missing anti-drug antibody result following the first dose of study drug or placebo. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and overall number of participants analyzed = 0 denotes that no participant had positive treatment-emergent ADA response to measure titer level.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=1 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=1 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part A: Number of Participants With Positive Treatment-emergent Antidrug Antibodies (ADA) by Maximum Titer Category Treatment-emergent ADA Titer: Low	1 Participants	1 Participants	0 Participants	—
Part A: Number of Participants With Positive Treatment-emergent Antidrug Antibodies (ADA) by Maximum Titer Category Treatment-emergent ADA Titer: Moderate	0 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Positive Treatment-emergent Antidrug Antibodies (ADA) by Maximum Titer Category Treatment-emergent ADA Titer: High	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: From Week 16 up to Week 52 in Part B

Population: Analysis was performed on AAS which included all participants who received any amount of study drug and had at least one non-missing anti-drug antibody result following the first dose.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=14 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose n=18 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose n=29 Participants Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=37 Participants Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part B: Number of Participants With Positive Treatment-emergent Antidrug Antibodies (ADA) Response and Titer	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Week 100

Population: Here 'n' = number of evaluable participants at the specified timepoint

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=41 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf At Week 100	92.7 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: At Week 160

Population: No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: Here 'n' = number of evaluable participants at the specified timepoint

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=41 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) From Baseline to Week 100	-91.50 Percentage of change Standard Deviation 13.348	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 160

Population: No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: Here 'n' = number of evaluable participants at the specified timepoint

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=41 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Absolute Change in Mean EoE-HSS From Baseline to Week 100 EoE-HSS Grade Score	-0.851 Score on a scale Standard Deviation 0.3909	—	—	—
Part C: Absolute Change in Mean EoE-HSS From Baseline to Week 100 EoE-HSS Stage Score	-0.850 Score on a scale Standard Deviation 0.3648	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 160

Population: No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: Here 'n' = number of evaluable participants at the specified timepoint

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=32 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Absolute Change in EoE-EREFS From Baseline to Week 100	-5.34 Score on a scale Standard Deviation 2.535	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 160

Population: No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: Here 'n' = number of evaluable participants at the specified timepoint

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=43 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Change in Total Score as Measured by the PEESSv2.0- Caregiver Version Questionnaire From Baseline to Week 100	-25.03 Score on a scale Standard Deviation 21.867	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: Here 'n' = number of evaluable participants at the specified timepoint

A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for the EDP reflect the expression at post-baseline relative to Baseline of a gene set that is differentially expressed between esophageal biopsies from EoE participants compared to healthy controls as a way to evaluate normalization of the molecular pathology. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=39 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: NES for the Relative Change in the EDP Transcriptome Signature From Baseline to Week 100	-2.720 Score on a scale Interval -2.8 to -2.51	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 160

Population: No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).

A Normalized Enrichment Score (NES) is a way to generate a single numerical value to represent a complex gene expression signature. Changes in NES score represented the overall changes in the expression of that molecular phenotype. The NESs calculated for the EDP reflect the expression at post-baseline relative to Baseline of a gene set that is differentially expressed between esophageal biopsies from EoE participants compared to healthy controls as a way to evaluate normalization of the molecular pathology. For each subject, an NES of 0 indicates no change from baseline, a negative score shows a reduction in disease score (more like normal) and positive score shows worsening (more active disease). NES does not have minimum/maximum score.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Week 100

Population: Here 'n' = number of evaluable participants at the specified timepoint

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=39 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: NES for the Relative Change in the Type 2 Inflammation Transcriptome Signature Baseline to Week 100	-1.970 Score on a scale Interval -2.0 to -1.9	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 160

Population: No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Week 100

Population: Here 'n' = number of evaluable participants at the specified timepoint

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=46 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Change in Body Weight for Age Percentile From Baseline up to Week 100	10.63 Percentile Standard Deviation 18.227	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 100

Population: Here 'n' = number of evaluable participants at the specified timepoint

Difference in the 100-week change from baseline in BMI-for-age Z-score. BMI-for-age Z-scores are based on a reference growth chart (based on the growth charts from Centers for Disease Control and Prevention \[CDC\] for ages 0 to 20 years \[for ages 2 to \<12 years\]. A z-score of "0" represents the population mean. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the population mean while a positive Z-score indicates values higher than the population mean.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=45 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Change in Body Mass Index for Age Z-score From Baseline up to Week 100	0.2009 z-score Standard Deviation 0.67389	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 100

Population: Here 'n' = number of evaluable participants at the specified timepoint.

Difference in the 100-week change from baseline in weight-for-age Z-score. Weight-for-age Z-scores are based on a reference growth chart (based on the growth charts from Centers for Disease Control and Prevention \[CDC\] for ages 0 to 20 years \[for ages 2 to \<12 years\]. A z-score of "0" represents the population mean. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the population mean while a positive Z-score indicates values higher than the population mean.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=46 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Change in Weight for Age Z-score From Baseline up to Week 100	0.3376 z-score Standard Deviation 0.59272	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 160

Population: No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).

Weight for age z-score indicates how much higher or lower a participant's weight for age is relative to a reference growth chart (based on the growth charts from CDC for ages 0 to 20 years \[for ages 2 to \<12 years\] and World Health Organization (WHO) growth charts for ages 0 to \<2 years \[for ages 1 to \<2 years\]). An increase in the mean change in weight for age z-score (increase in the SD from the reference growth chart) indicates an increase in weight for age relative to the reference.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Week 100

Population: Here 'n' = number of evaluable participants at the specified timepoint

Difference in the 100-week change from baseline in Weight for height Z-score. Weight for height Z-scores are based on a reference growth chart (based on the growth charts from Centers for Disease Control and Prevention \[CDC\] for ages 0 to 20 years \[for ages 2 to \<12 years\]. A z-score of "0" represents the population mean. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the population mean while a positive Z-score indicates values higher than the population mean.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=15 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Change in Weight for Height Z-score From Baseline up to Week 100	0.3301 z-score Standard Deviation 0.84791	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 160

Population: No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).

Weight for height z-score indicates how much higher or lower a participant's weight for height is relative to a reference growth chart (based on the growth charts from CDC for ages 0 to 20 years \[for ages 2 to \<12 years\] and WHO growth charts for ages 0 to \<2 years \[for ages 1 to \<2 years\]). An increase in the mean change in weight for height z-score (increase in the SD from the reference growth chart) indicates an increase in weight for height relative to the reference.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Week 100

Population: Here 'n' = number of evaluable participants at the specified timepoint

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=41 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eos/Hpf (400×) at Week 100	70.7 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: At Week 160

Population: No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Week 100

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=61 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Percentage of Participants (With Food Elimination Diet Regimens at Baseline) That Have a Re-introduction of a Previously Eliminated Food Group From Baseline up to Week 100	14.8 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 160

Population: No data was collected for this endpoint. No participants reached end of part C treatment period (week 160).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 152

Population: No participants completed 160 weeks, longest duration was 152 weeks.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=61 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Number of Participants With TEAEs	53 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to Week 152

Population: No participants completed 160 weeks, longest duration was 152 weeks.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=61 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Number of Participants With Treatment-emergent SAEs	3 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to Week 152

Population: No participants completed 160 weeks, longest duration was 152 weeks.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=61 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Number of Participants With Treatment-emergent AESIs	6 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to Week 152

Population: No participants completed 160 weeks, longest duration was 152 weeks.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=61 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Treatment	0 Participants	—	—	—

SECONDARY outcome

Timeframe: From Week 52 up to Week 152

Population: Anti-Drug Antibody Analysis Set (AAS): The Part C AAS included all participants who received any amount of study drug in Part C and had at least 1 non-missing ADA result following the first dose of study drug. Analysis was based on treatment received.

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=39 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Number of Participants With Treatment-emergent ADA Responses	0 Participants	—	—	—

SECONDARY outcome

Timeframe: At Week 100

Outcome measures

Outcome measures
Measure	Part A: Pooled Placebo n=42 Participants Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part A: Dupilumab Low Dose Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.
Part C: Concentration of Functional Dupilumab in Serum at Week 100	180 mg/L Standard Deviation 96.9	—	—	—

Adverse Events

Part A: Pooled Placebo (Placebo)

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Part A: Dupilumab Low Dose

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Part A: Dupilumab High Dose

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Part B: Placebo to Dupilumab Low Dos

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Part B: Placebo to Dupilumab High Dose

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Part B: Dupilumab Low Dose to Dupilumab Low Dose

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Part B: Dupilumab High Dose to Dupilumab High Dose

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Part C: Dupilumab

Serious events: 3 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Pooled Placebo (Placebo) n=34 participants at risk Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab Low Dose n=30 participants at risk Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W	Part A: Dupilumab High Dose n=37 participants at risk Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part B: Placebo to Dupilumab Low Dos n=14 participants at risk Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W	Part B: Placebo to Dupilumab High Dose n=18 participants at risk Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part B: Dupilumab Low Dose to Dupilumab Low Dose n=29 participants at risk Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=37 participants at risk Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part C: Dupilumab n=61 participants at risk Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment
Injury, poisoning and procedural complications Procedural pain	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Renal and urinary disorders Nephrolithiasis	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
General disorders Pyrexia	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Infections and infestations HCoV-OC43 infection	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Cardiac disorders Cardiac arrest	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Oesophageal food impaction	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Infections and infestations Perirectal abscess	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Investigations Endoscopy gastrointestinal	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.

Other adverse events

Other adverse events
Measure	Part A: Pooled Placebo (Placebo) n=34 participants at risk Participants who received subcutaneous (SC) injection of placebo matched to higher exposure dupilumab or lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W). Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part A: Dupilumab Low Dose n=30 participants at risk Participants received subcutaneous (SC) injection of lower exposure dupilumab in Part A. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W	Part A: Dupilumab High Dose n=37 participants at risk Participants received subcutaneous (SC) injection of higher exposure dupilumab in Part A. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part B: Placebo to Dupilumab Low Dos n=14 participants at risk Participants who received subcutaneous (SC) injection of placebo in Part A and received lower exposure dupilumab in Part B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W	Part B: Placebo to Dupilumab High Dose n=18 participants at risk Participants who received subcutaneous (SC) injection of placebo in Part A and received higher exposure dupilumab in Part B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW	Part B: Dupilumab Low Dose to Dupilumab Low Dose n=29 participants at risk Participants received subcutaneous (SC) injection of lower exposure dupilumab in Parts A and B. Lower exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab Q2W)	Part B: Dupilumab High Dose to Dupilumab High Dose n=37 participants at risk Participants received subcutaneous (SC) injection of higher exposure dupilumab in Parts A and B. Higher exposure dupilumab regimen were exposures approximating those in adolescents and adults receiving 300 mg dupilumab QW.	Part C: Dupilumab n=61 participants at risk Participants who completed Part A and B were eligible to enroll in Part C and receive Dupilumab extended active treatment
Infections and infestations Sinusitis	8.8% 3/34 • Number of events 3 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Infections and infestations Upper respiratory tract infection	8.8% 3/34 • Number of events 3 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	14.3% 2/14 • Number of events 2 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	27.6% 8/29 • Number of events 9 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	13.1% 8/61 • Number of events 8 • From signing of the informed consent up to week 152.
Infections and infestations Ear infection	5.9% 2/34 • Number of events 3 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	8.2% 5/61 • Number of events 5 • From signing of the informed consent up to week 152.
Infections and infestations Molluscum contagiosum	5.9% 2/34 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Infections and infestations Nasopharyngitis	5.9% 2/34 • Number of events 2 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	8.1% 3/37 • Number of events 6 • From signing of the informed consent up to week 152.	6.6% 4/61 • Number of events 4 • From signing of the informed consent up to week 152.
Infections and infestations Viral upper respiratory tract infection	5.9% 2/34 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	13.8% 4/29 • Number of events 4 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	4.9% 3/61 • Number of events 4 • From signing of the informed consent up to week 152.
Infections and infestations Gastroenteritis viral	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	10.8% 4/37 • Number of events 4 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	8.2% 5/61 • Number of events 7 • From signing of the informed consent up to week 152.
Infections and infestations COVID-19	0.00% 0/34 • From signing of the informed consent up to week 152.	30.0% 9/30 • Number of events 9 • From signing of the informed consent up to week 152.	16.2% 6/37 • Number of events 6 • From signing of the informed consent up to week 152.	21.4% 3/14 • Number of events 3 • From signing of the informed consent up to week 152.	33.3% 6/18 • Number of events 7 • From signing of the informed consent up to week 152.	24.1% 7/29 • Number of events 7 • From signing of the informed consent up to week 152.	29.7% 11/37 • Number of events 11 • From signing of the informed consent up to week 152.	8.2% 5/61 • Number of events 6 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Vomiting	17.6% 6/34 • Number of events 15 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	8.1% 3/37 • Number of events 7 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	11.1% 2/18 • Number of events 2 • From signing of the informed consent up to week 152.	10.3% 3/29 • Number of events 6 • From signing of the informed consent up to week 152.	13.5% 5/37 • Number of events 7 • From signing of the informed consent up to week 152.	18.0% 11/61 • Number of events 24 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Abdominal pain	8.8% 3/34 • Number of events 3 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	11.1% 2/18 • Number of events 3 • From signing of the informed consent up to week 152.	10.3% 3/29 • Number of events 3 • From signing of the informed consent up to week 152.	10.8% 4/37 • Number of events 4 • From signing of the informed consent up to week 152.	4.9% 3/61 • Number of events 3 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Constipation	5.9% 2/34 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	6.9% 2/29 • Number of events 2 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	4.9% 3/61 • Number of events 3 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Diarrhoea	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	6.7% 2/30 • Number of events 3 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 2 • From signing of the informed consent up to week 152.	16.7% 3/18 • Number of events 9 • From signing of the informed consent up to week 152.	10.3% 3/29 • Number of events 3 • From signing of the informed consent up to week 152.	8.1% 3/37 • Number of events 3 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/34 • From signing of the informed consent up to week 152.	6.7% 2/30 • Number of events 2 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 2 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	10.3% 3/29 • Number of events 3 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 2 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/34 • From signing of the informed consent up to week 152.	6.7% 2/30 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 2 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	8.2% 5/61 • Number of events 5 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Nausea	0.00% 0/34 • From signing of the informed consent up to week 152.	10.0% 3/30 • Number of events 3 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 3 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	11.1% 2/18 • Number of events 2 • From signing of the informed consent up to week 152.	6.9% 2/29 • Number of events 2 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 3 • From signing of the informed consent up to week 152.
General disorders Injection site reaction	20.6% 7/34 • Number of events 8 • From signing of the informed consent up to week 152.	13.3% 4/30 • Number of events 11 • From signing of the informed consent up to week 152.	10.8% 4/37 • Number of events 11 • From signing of the informed consent up to week 152.	28.6% 4/14 • Number of events 34 • From signing of the informed consent up to week 152.	27.8% 5/18 • Number of events 21 • From signing of the informed consent up to week 152.	13.8% 4/29 • Number of events 17 • From signing of the informed consent up to week 152.	13.5% 5/37 • Number of events 18 • From signing of the informed consent up to week 152.	8.2% 5/61 • Number of events 32 • From signing of the informed consent up to week 152.
General disorders Injection site erythema	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 2 • From signing of the informed consent up to week 152.	10.8% 4/37 • Number of events 8 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	11.1% 2/18 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 2 • From signing of the informed consent up to week 152.
General disorders Pyrexia	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	21.4% 3/14 • Number of events 3 • From signing of the informed consent up to week 152.	11.1% 2/18 • Number of events 4 • From signing of the informed consent up to week 152.	10.3% 3/29 • Number of events 3 • From signing of the informed consent up to week 152.	16.2% 6/37 • Number of events 7 • From signing of the informed consent up to week 152.	18.0% 11/61 • Number of events 18 • From signing of the informed consent up to week 152.
General disorders Fatigue	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	16.7% 3/18 • Number of events 3 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
General disorders Injection site pain	0.00% 0/34 • From signing of the informed consent up to week 152.	10.0% 3/30 • Number of events 3 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	21.4% 3/14 • Number of events 6 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 3 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	4.9% 3/61 • Number of events 5 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 2/34 • Number of events 2 • From signing of the informed consent up to week 152.	6.7% 2/30 • Number of events 2 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 2 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	27.8% 5/18 • Number of events 7 • From signing of the informed consent up to week 152.	13.8% 4/29 • Number of events 4 • From signing of the informed consent up to week 152.	13.5% 5/37 • Number of events 6 • From signing of the informed consent up to week 152.	13.1% 8/61 • Number of events 11 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	8.8% 3/34 • Number of events 3 • From signing of the informed consent up to week 152.	6.7% 2/30 • Number of events 2 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	10.3% 3/29 • Number of events 4 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Skin and subcutaneous tissue disorders Rash	5.9% 2/34 • Number of events 2 • From signing of the informed consent up to week 152.	10.0% 3/30 • Number of events 3 • From signing of the informed consent up to week 152.	8.1% 3/37 • Number of events 4 • From signing of the informed consent up to week 152.	14.3% 2/14 • Number of events 4 • From signing of the informed consent up to week 152.	11.1% 2/18 • Number of events 4 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 2 • From signing of the informed consent up to week 152.	10.8% 4/37 • Number of events 7 • From signing of the informed consent up to week 152.	8.2% 5/61 • Number of events 5 • From signing of the informed consent up to week 152.
Skin and subcutaneous tissue disorders Eczema	2.9% 1/34 • Number of events 2 • From signing of the informed consent up to week 152.	6.7% 2/30 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	11.1% 2/18 • Number of events 2 • From signing of the informed consent up to week 152.	6.9% 2/29 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	4.9% 3/61 • Number of events 3 • From signing of the informed consent up to week 152.
Skin and subcutaneous tissue disorders Urticaria	5.9% 2/34 • Number of events 2 • From signing of the informed consent up to week 152.	6.7% 2/30 • Number of events 2 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 3 • From signing of the informed consent up to week 152.	21.4% 3/14 • Number of events 3 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	6.9% 2/29 • Number of events 2 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 2 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 2 • From signing of the informed consent up to week 152.
Immune system disorders Seasonal allergy	5.9% 2/34 • Number of events 2 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	13.8% 4/29 • Number of events 4 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	6.6% 4/61 • Number of events 5 • From signing of the informed consent up to week 152.
Nervous system disorders Dizziness	5.9% 2/34 • Number of events 2 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 2 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Nervous system disorders Headache	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	13.3% 4/30 • Number of events 5 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	22.2% 4/18 • Number of events 4 • From signing of the informed consent up to week 152.	10.3% 3/29 • Number of events 5 • From signing of the informed consent up to week 152.	10.8% 4/37 • Number of events 4 • From signing of the informed consent up to week 152.	9.8% 6/61 • Number of events 9 • From signing of the informed consent up to week 152.
Psychiatric disorders Fear of injection	5.9% 2/34 • Number of events 9 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Eye disorders Eye swelling	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	6.7% 2/30 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	10.3% 3/29 • Number of events 3 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Infections and infestations Hordeolum	2.9% 1/34 • Number of events 4 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 3 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 3 • From signing of the informed consent up to week 152.
Infections and infestations Respiratory tract infection viral	2.9% 1/34 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 3 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 2 • From signing of the informed consent up to week 152.
Infections and infestations Beta haemolytic streptococcal infection	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Infections and infestations Conjunctivitis	0.00% 0/34 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	11.1% 2/18 • Number of events 2 • From signing of the informed consent up to week 152.	13.8% 4/29 • Number of events 4 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	6.6% 4/61 • Number of events 5 • From signing of the informed consent up to week 152.
Infections and infestations Croup infectious	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	6.6% 4/61 • Number of events 4 • From signing of the informed consent up to week 152.
Infections and infestations Ear infection viral	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Infections and infestations Eye infection	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	6.9% 2/29 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Infections and infestations Gastrointestinal viral infection	0.00% 0/34 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	6.9% 2/29 • Number of events 2 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Infections and infestations Groin infection	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Infections and infestations Impetigo	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Infections and infestations Influenza	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	28.6% 4/14 • Number of events 4 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	13.8% 4/29 • Number of events 4 • From signing of the informed consent up to week 152.	10.8% 4/37 • Number of events 4 • From signing of the informed consent up to week 152.	4.9% 3/61 • Number of events 3 • From signing of the informed consent up to week 152.
Infections and infestations Otitis media	0.00% 0/34 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	8.1% 3/37 • Number of events 3 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 2 • From signing of the informed consent up to week 152.
Infections and infestations Pharyngitis	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 4 • From signing of the informed consent up to week 152.
Infections and infestations Pharyngitis streptococcal	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	14.3% 2/14 • Number of events 2 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 2 • From signing of the informed consent up to week 152.	6.9% 2/29 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	21.3% 13/61 • Number of events 15 • From signing of the informed consent up to week 152.
Infections and infestations Rhinitis	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	11.1% 2/18 • Number of events 3 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Infections and infestations Stoma site infection	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Infections and infestations Tonsillitis	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Infections and infestations Urinary tract infection	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Infections and infestations Viral infection	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Eosinophilic oesophagitis	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	14.3% 2/14 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Oral pain	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Dyspepsia	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	11.1% 2/18 • Number of events 2 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Dysphagia	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	6.9% 2/29 • Number of events 3 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Lip blister	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Oral discomfort	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
General disorders Injection site haemorrhage	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 2 • From signing of the informed consent up to week 152.
General disorders Injection site swelling	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
General disorders Chest pain	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	8.1% 3/37 • Number of events 3 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
General disorders Influenza like illness	0.00% 0/34 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
General disorders Injection site induration	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
General disorders Injection site inflammation	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	6.9% 2/29 • Number of events 4 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
General disorders Injection site oedema	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 4 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
General disorders Malaise	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
General disorders Vessel puncture site pain	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Asthma	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	17.2% 5/29 • Number of events 6 • From signing of the informed consent up to week 152.	8.1% 3/37 • Number of events 3 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 2 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	14.3% 2/14 • Number of events 2 • From signing of the informed consent up to week 152.	11.1% 2/18 • Number of events 2 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 3 • From signing of the informed consent up to week 152.	9.8% 6/61 • Number of events 6 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 2 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Wheezing	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 2 • From signing of the informed consent up to week 152.	4.9% 3/61 • Number of events 4 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/34 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	10.8% 4/37 • Number of events 4 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Oropharyngeal cobble stone mucosa	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/34 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	14.3% 2/14 • Number of events 3 • From signing of the informed consent up to week 152.	11.1% 2/18 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 2 • From signing of the informed consent up to week 152.	4.9% 3/61 • Number of events 4 • From signing of the informed consent up to week 152.
Skin and subcutaneous tissue disorders Dry skin	5.9% 2/34 • Number of events 2 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	4.9% 3/61 • Number of events 3 • From signing of the informed consent up to week 152.
Skin and subcutaneous tissue disorders Rash papular	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 3 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	4.9% 3/61 • Number of events 3 • From signing of the informed consent up to week 152.
Skin and subcutaneous tissue disorders Hand dermatitis	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Skin and subcutaneous tissue disorders Keratosis pilaris	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/34 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 2 • From signing of the informed consent up to week 152.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/34 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Psychiatric disorders Insomnia	5.9% 2/34 • Number of events 2 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	6.9% 2/29 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Psychiatric disorders Enuresis	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Immune system disorders Food allergy	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	11.1% 2/18 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 2 • From signing of the informed consent up to week 152.
Immune system disorders Immunisation reaction	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 3 • From signing of the informed consent up to week 152.
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	16.7% 3/18 • Number of events 3 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 3 • From signing of the informed consent up to week 152.	6.6% 4/61 • Number of events 4 • From signing of the informed consent up to week 152.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Nervous system disorders Lethargy	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Ear and labyrinth disorders Otorrhoea	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Ear and labyrinth disorders Ear pain	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Eye disorders Conjunctivitis allergic	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Eye disorders Dry eye	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Eye disorders Eye pruritus	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 2 • From signing of the informed consent up to week 152.
Eye disorders Ocular hyperaemia	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	13.8% 4/29 • Number of events 7 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Injury, poisoning and procedural complications Ligament sprain	2.9% 1/34 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 2 • From signing of the informed consent up to week 152.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 2 • From signing of the informed consent up to week 152.
Injury, poisoning and procedural complications Face injury	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	6.9% 2/29 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	3.3% 2/61 • Number of events 2 • From signing of the informed consent up to week 152.
Injury, poisoning and procedural complications Gas poisoning	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Injury, poisoning and procedural complications Nasal injury	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Injury, poisoning and procedural complications Sunburn	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	3.4% 1/29 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Investigations Alanine aminotransferase increased	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Investigations Aspartate aminotransferase increased	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Investigations Blood potassium increased	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Investigations Hepatic enzyme increased	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Reproductive system and breast disorders Genital pain	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Reproductive system and breast disorders Genital rash	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	7.1% 1/14 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Immune system disorders Anaphylactic reaction	0.00% 0/34 • From signing of the informed consent up to week 152.	3.3% 1/30 • Number of events 1 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	6.9% 2/29 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Infections and infestations Pneumonia	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Injury, poisoning and procedural complications Limb injury	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	2.7% 1/37 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	5.4% 2/37 • Number of events 2 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Investigations Neutrophil count decreased	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/61 • From signing of the informed consent up to week 152.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	0.00% 0/18 • From signing of the informed consent up to week 152.	6.9% 2/29 • Number of events 4 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/34 • From signing of the informed consent up to week 152.	0.00% 0/30 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	0.00% 0/14 • From signing of the informed consent up to week 152.	5.6% 1/18 • Number of events 1 • From signing of the informed consent up to week 152.	0.00% 0/29 • From signing of the informed consent up to week 152.	0.00% 0/37 • From signing of the informed consent up to week 152.	1.6% 1/61 • Number of events 1 • From signing of the informed consent up to week 152.

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals, Inc.

Phone: 844-734-6643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER