Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

• ClinicalTrials.gov Identifier: NCT03633617
• Recruitment Status: Completed
• First Posted: August 16, 2018
• Results First Posted: December 28, 2022
• Last Update Posted: June 28, 2023
• Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Information provided by (Responsible Party): Regeneron Pharmaceuticals

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Eosinophilic Esophagitis
• Interventions: Drug: Dupilumab; Drug: Placebo
• Enrollment: 321

Participant Flow

Recruitment Details
Pre-assignment Details	Part A (24-week DBTP):157 participants screened, 81 randomized and received at least 1 dose of study drug; Part B (24-week DBTP): 462 participants screened, 240 randomized, 239 received treatment (1 participant randomized to placebo did not meet eligibility criteria and was discontinued prior to being treated).

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Period Title: Part A
Started [1]	39	42	0	0	0	0	0	0	0	0	0
Completed [2]	36	37	0	0	0	0	0	0	0	0	0
Not Completed	3	5	0	0	0	0	0	0	0	0	0
Reason Not Completed
Week 24 not performed due to Coronavirus Disease-2019 (COVID-19)	1	3	0	0	0	0	0	0	0	0	0
Unconfirmed early termination visit	1	0	0	0	0	0	0	0	0	0	0
Adverse Event	0	1	0	0	0	0	0	0	0	0	0
Pregnancy	1	0	0	0	0	0	0	0	0	0	0
Withdrawal by Subject	0	1	0	0	0	0	0	0	0	0	0
[1] Started Part A; [2] Completed week 24 visit for Part A
Period Title: Part B
Started [1]	0	0	79	81	80	0	0	0	0	0	0
Completed [2]	0	0	74	79	75	0	0	0	0	0	0
Not Completed	0	0	5	2	5	0	0	0	0	0	0
Reason Not Completed
Adverse Event	0	0	2	2	1	0	0	0	0	0	0
Withdrawal by Subject	0	0	1	0	2	0	0	0	0	0	0
Lost to Follow-up	0	0	0	0	1	0	0	0	0	0	0
Physician Decision	0	0	0	0	1	0	0	0	0	0	0
COVID-19 Restrictions	0	0	1	0	0	0	0	0	0	0	0
Subject randomized, but did not receive study drug; did not qualify for study	0	0	1	0	0	0	0	0	0	0	0
[1] Started Part B (Participants from Part A were not eligible for Part B); [2] Completed week 24 visit for Part B
Period Title: Part C (& Follow-up)
Started	0	0	0	0	0	37	40	37	37	79	74
Completed Week 52 (End of Treatment)	0	0	0	0	0	32	38	34	36	74	65
Completed [1]	0	0	0	0	0	30	35	33	36	67	64
Not Completed	0	0	0	0	0	7	5	4	1	12	10
Reason Not Completed
Adverse Event	0	0	0	0	0	1	0	1	0	0	0
Pregnancy	0	0	0	0	0	0	0	0	0	1	0
Withdrawal by Subject	0	0	0	0	0	2	2	0	1	1	6
Lost to Follow-up	0	0	0	0	0	3	3	1	0	7	2
Physician Decision	0	0	0	0	0	0	0	1	0	0	1
COVID-19 related	0	0	0	0	0	1	0	0	0	0	0
Protocol Violation	0	0	0	0	0	0	0	0	0	3	1
Lack of Efficacy	0	0	0	0	0	0	0	1	0	0	0
[1] Completed follow-up (end of study)

Baseline Characteristics

Arm/Group Title		Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW	Total
Arm/Group Description		Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Total of all reporting groups
Overall Number of Baseline Participants		39	42	79	81	80	321
Baseline Analysis Population Description		Part A Full analysis set (FAS) includes all randomized participants in Part A; Part B FAS includes all randomized participants in Part B. Participants who participated in Part A were not eligible to participate in Part B.
Age, Customized [1] [2]; Measure Type: Number; Unit of measure: Participants
≥ 12 to < 18 years old	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
		9	11				20
≥ 18 to < 40 years old	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
		22	13				35
≥ 40 to < 65 years old	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
		8	18				26
≥ 65 years old	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
		0	0				0
		[1] Measure Description: Part A: Age; [2] Measure Analysis Population Description: Part A Full Analysis Set (FAS): All randomized participants in Part A
Age, Customized [1] [2]; Measure Type: Number; Unit of measure: Participants
≥ 12 to < 18 years old	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
				26	27	26	79
≥ 18 to < 40 years old	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
				38	35	38	111
≥ 40 to < 65 years old	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
				15	18	15	48
≥ 65 years old	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
				0	1	1	2
		[1] Measure Description: Part B: Age; [2] Measure Analysis Population Description: Part B FAS: All randomized participants in Part B
Sex: Female, Male [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
	Female	18 46.2%	14 33.3%				32 39.5%
	Male	21 53.8%	28 66.7%				49 60.5%
		[1] Measure Description: Part A: Sex: Female, Male; [2] Measure Analysis Population Description: Part A FAS: All randomized participants in Part A
Sex: Female, Male [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
	Female			21 26.6%	36 44.4%	30 37.5%	87 36.3%
	Male			58 73.4%	45 55.6%	50 62.5%	153 63.7%
		[1] Measure Description: Part B: Sex: Female, Male; [2] Measure Analysis Population Description: Part B FAS: All randomized participants in Part B
Ethnicity (NIH/OMB) [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
	Hispanic or Latino	1 2.6%	4 9.5%				5 6.2%
	Not Hispanic or Latino	38 97.4%	38 90.5%				76 93.8%
	Unknown or Not Reported	0 0.0%	0 0.0%				0 0.0%
		[1] Measure Description: Part A: Ethnicity (NIH/OMB); [2] Measure Analysis Population Description: Part A FAS: All randomized participants in Part A
Ethnicity (NIH/OMB) [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
	Hispanic or Latino			5 6.3%	3 3.7%	5 6.3%	13 5.4%
	Not Hispanic or Latino			74 93.7%	77 95.1%	75 93.8%	226 94.2%
	Unknown or Not Reported			0 0.0%	1 1.2%	0 0.0%	1 0.4%
		[1] Measure Description: Part B: Ethnicity (NIH/OMB); [2] Measure Analysis Population Description: Part B FAS: All randomized participants in Part B
Race/Ethnicity, Customized [1] [2]; Measure Type: Number; Unit of measure: Participants
White	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
		37	41				78
Black or African American	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
		1	1				2
Asian	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
		0	0				0
Other	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
		1	0				1
Not reported	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
		0	0				0
		[1] Measure Description: Part A: Race; [2] Measure Analysis Population Description: Part A FAS: All randomized participants in Part A
Race/Ethnicity, Customized [1] [2]; Measure Type: Number; Unit of measure: Participants
White	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
				72	74	71	217
Black or African American	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
				3	3	2	8
Asian	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
				1	1	3	5
Other	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
				2	2	3	7
Not reported	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
				1	1	1	3
		[1] Measure Description: Part B: Race; [2] Measure Analysis Population Description: Part B FAS: All randomized participants in Part B
Part A: Dysphagia Symptom Questionnaire (DSQ) Total Score [1] [2]; Mean (Standard Deviation); Unit of measure: Score on a Scale
	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
		35.1 (12.11)	32.2 (12.66)				33.6 (12.41)
		[1] Measure Description: The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.; [2] Measure Analysis Population Description: Part A FAS: All randomized participants in Part A
Part B: Dysphagia Symptom Questionnaire (DSQ) Total Score [1] [2]; Mean (Standard Deviation); Unit of measure: Score on a Scale
	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
				36.1 (10.55)	35.6 (12.24)	38.4 (10.70)	36.7 (11.22)
		[1] Measure Description: The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less frequent or less severe dysphagia.; [2] Measure Analysis Population Description: Part B FAS: All randomized participants in Part B
Part A: Peak Eosinophils (eos) Count of Three Regions per High-power Field (/hpf) [1]; Mean (Standard Deviation); Unit of measure: Eosinophils/high-power field (eos/hpf)
	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
		96.5 (54.69)	82.6 (41.02)				89.3 (48.29)
		[1] Measure Analysis Population Description: Part A FAS: All randomized participants in Part A
Part B: Peak Eosinophils (eos) Count of Three Regions per High-power Field (/hpf) [1]; Mean (Standard Deviation); Unit of measure: Eosinophils/high-power field (eos/hpf)
	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
				84.3 (41.20)	87.7 (49.37)	89.2 (46.67)	87.1 (45.76)
		[1] Measure Analysis Population Description: Part B FAS: All randomized participants in Part B
Part A: Eosinophilic Esophagitis (EoE) Histological Grade Calculated Mean Score (0 - 3) [1] [2]; Mean (Standard Deviation); Unit of measure: Score on a Scale
	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
		1.324 (0.4676)	1.260 (0.4088)				1.291 (0.4365)
		[1] Measure Description: Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.; [2] Measure Analysis Population Description: Part A FAS: All randomized participants in Part A
Part B: Eosinophilic Esophagitis (EoE) Histological Grade Calculated Mean Score (0 - 3) [1] [2]; Mean (Standard Deviation); Unit of measure: Score on a Scale
	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
				1.226 (0.3996)	1.245 (0.3721)	1.305 (0.3882)	1.259 (0.3865)
		[1] Measure Description: Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.; [2] Measure Analysis Population Description: Part B FAS: All randomized participants in Part B
Part A: Eosinophilic Esophagitis (EoE) Histological Stage Calculated Mean Score (0 - 3) [1] [2]; Mean (Standard Deviation); Unit of measure: Score on a Scale
	Number Analyzed	39 participants	42 participants	0 participants	0 participants	0 participants	81 participants
		1.376 (0.3972)	1.299 (0.3334)				1.336 (0.3653)
		[1] Measure Description: Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.; [2] Measure Analysis Population Description: Part A FAS: All randomized participants in Part A
Part B: Eosinophilic Esophagitis (EoE) Histological Stage Calculated Mean Score (0 - 3) [1] [2]; Mean (Standard Deviation); Unit of measure: Score on a Scale
	Number Analyzed	0 participants	0 participants	79 participants	81 participants	80 participants	240 participants
				1.216 (0.3608)	1.248 (0.3182)	1.294 (0.3256)	1.253 (0.3353)
		[1] Measure Description: Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.; [2] Measure Analysis Population Description: Part B FAS: All randomized participants in Part B

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 24
Description	Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Time Frame	At week 24

Outcome Measure Data

Analysis Population Description

Part A Full Analysis Set (FAS): All participants randomized to Part A (Participants considered non-responder after rescue treatment use and multiple imputation (MI) method for missing due to COVID-19); Part B FAS: All participants randomized to Part B (Participants considered non-responder after rescue treatment use or missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19)

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	39	42	79	81	80
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	5.1; (0.63 to 17.32)	59.5; (43.28 to 74.37)	6.3; (2.09 to 14.16)	60.5; (49.01 to 71.19)	58.8; (47.18 to 69.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	55.3
	Confidence Interval	(2-Sided) 95%; 39.58 to 71.04
	Estimation Comments	Difference is dupilumab minus placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	56.0
	Confidence Interval	(2-Sided) 95%; 43.44 to 68.54
	Estimation Comments	Difference is dupilumab minus placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	53.5
	Confidence Interval	(2-Sided) 95%; 41.20 to 65.79
	Estimation Comments	Difference is dupilumab minus placebo

2. Primary Outcome

Title	Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24
Description	The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

Part A Full Analysis Set (FAS): All participant randomized to Part A (MI method with data set to missing after rescue treatment use); Part B FAS: All participants randomized to Part B (MI method with data set to missing after rescue treatment use)

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	39	42	79	81	80
Least Squares Mean (95% Confidence Interval); Unit of Measure: Score on a Scale
	-9.60; (-15.056 to -4.136)	-21.92; (-26.870 to -16.967)	-13.86; (-17.605 to -10.120)	-14.37; (-18.018 to -10.723)	-23.78; (-27.427 to -20.131)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0004
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-12.32
	Confidence Interval	(2-Sided) 95%; -19.107 to -5.537
	Estimation Comments	Dupilumab group vs. Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8393
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95%; -5.423 to 4.406
	Estimation Comments	Dupilumab group vs. Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-9.92
	Confidence Interval	(2-Sided) 95%; -14.811 to -5.022
	Estimation Comments	Dupilumab group vs. Placebo

3. Secondary Outcome

Title	Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 24
Description	Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). A greater esophageal intraepithelial eosinophil count from baseline indicates worsening disease.
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

Part A FAS (Worst-observation carried forward [WOCF]-MI method with data set to missing after rescue treatment use); Part B FAS (WOCF-MI method with WOCF for rescue treatment use and missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19)

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	39	42	79	81	80
Least Squares Mean (95% Confidence Interval); Unit of Measure: Percentage of Change
	-2.98; (-17.886 to 11.921)	-71.24; (-84.863 to -57.613)	8.38; (-11.677 to 28.433)	-70.84; (-87.095 to -54.585)	-80.24; (-96.589 to -63.895)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-68.26
	Confidence Interval	(2-Sided) 95%; -86.896 to -49.615
	Estimation Comments	Dupilumab 300 mg QW vs Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-79.22
	Confidence Interval	(2-Sided) 95%; -103.098 to -55.338
	Estimation Comments	Dupilumab 300 mg Q2W vs Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-88.62
	Confidence Interval	(2-Sided) 95%; -112.194 to -65.046
	Estimation Comments	Dupilumab 300 mg QW vs Placebo

4. Secondary Outcome

Title	Percent Change From Baseline in DSQ Total Score at Week 24
Description	The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

Part A FAS (MI method with data set to missing after rescue treatment use); Part B FAS (MI method with data set to missing after rescue treatment use)

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	39	42	79	81	80
Least Squares Mean (95% Confidence Interval); Unit of Measure: Percentage of Change
	-31.68; (-47.545 to -15.818)	-69.17; (-83.578 to -54.752)	-41.43; (-51.749 to -31.116)	-45.78; (-55.658 to -35.904)	-64.32; (-74.267 to 54.382)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-37.48
	Confidence Interval	(2-Sided) 95%; -57.222 to -17.745
	Estimation Comments	Dupilumab 300 mg QW vs Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5243
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-4.35
	Confidence Interval	(2-Sided) 95%; -17.734 to 9.038
	Estimation Comments	Dupilumab 300 mg Q2W vs Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0008
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-22.89
	Confidence Interval	(2-Sided) 95%; -36.272 to -9.513
	Estimation Comments	Dupilumab 300 mg QW vs Placebo

5. Secondary Outcome

Title	Absolute Change From Baseline in Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Mean Grade Score at Week 24
Description	Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

Part A FAS (WOCF-MI method with data set to missing after rescue treatment use); Part B FAS (WOCF-MI method with WOCF for rescue treatment use and missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19)

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	39	42	79	81	80
Least Squares Mean (95% Confidence Interval); Unit of Measure: Score on a Scale
	-0.001; (-0.1166 to 0.1139)	-0.761; (-0.8732 to -0.6484)	-0.148; (-0.2379 to -0.0584)	-0.814; (-0.8958 to -0.7317)	-0.830; (-0.9136 to -0.7463)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.759
	Confidence Interval	(2-Sided) 95%; -0.9061 to -0.6127
	Estimation Comments	Dupilumab 300 mg QW vs Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.666
	Confidence Interval	(2-Sided) 95%; -0.7773 to -0.5538
	Estimation Comments	Dupilumab 300 mg Q2W vs Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.682
	Confidence Interval	(2-Sided) 95%; -0.7929 to -0.5707
	Estimation Comments	Dupilumab 300 mg QW vs Placebo

6. Secondary Outcome

Title	Absolute Change From Baseline in EoEHSS Mean Stage Score at Week 24
Description	Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

Part A FAS (WOCF-MI Method With Data Set to Missing After Rescue Treatment Use); Part B FAS (WOCF-MI Method with WOCF for Rescue Treatment Use and Missing Not Due to COVID-19 and MI Method for Missing or Dosing Interruption Due to COVID-19)

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	39	42	79	81	80
Least Squares Mean (95% Confidence Interval); Unit of Measure: Score on a Scale
	-0.012; (-0.1243 to 0.0995)	-0.753; (-0.8627 to -0.6441)	-0.132; (-0.2179 to -0.0464)	-0.793; (-0.8713 to -0.7144)	-0.804; (-0.8839 to -0.7237)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.741
	Confidence Interval	(2-Sided) 95%; -0.8842 to -0.5978
	Estimation Comments	Dupilumab 300 mg QW vs Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.661
	Confidence Interval	(2-Sided) 95%; -0.7674 to -0.5540
	Estimation Comments	Dupilumab 300 mg Q2W vs Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.672
	Confidence Interval	(2-Sided) 95%; -0.7778 to -0.5655
	Estimation Comments	Dupilumab 300 mg QW vs Placebo

7. Secondary Outcome

Title	Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 24
Description	EoE esophageal characteristics analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

Part A FAS (WOCF-MI Method With Data Set to Missing After Rescue Treatment Use); Part B FAS (WOCF-MI Method with WOCF for Rescue Treatment Use and Missing Not Due to COVID-19 and MI Method for Missing or Dosing Interruption Due to COVID-19)

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	39	42	79	81	80
Least Squares Mean (95% Confidence Interval); Unit of Measure: Score on a Scale
	-0.3; (-1.11 to 0.50)	-3.2; (-3.98 to -2.38)	-0.6; (-1.37 to 0.12)	-4.6; (-5.24 to -3.89)	-4.5; (-5.17 to -3.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-2.9
	Confidence Interval	(2-Sided) 95%; -3.91 to -1.84
	Estimation Comments	Dupilumab 300 mg QW vs Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-3.9
	Confidence Interval	(2-Sided) 95%; -4.86 to -3.02
	Estimation Comments	Dupilumab 300 mg Q2W vs Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-3.8
	Confidence Interval	(2-Sided) 95%; -4.77 to -2.93
	Estimation Comments	Dupilumab 300 mg QW vs Placebo

8. Secondary Outcome

Title	Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 24
Description	Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Time Frame	At week 24

Outcome Measure Data

Analysis Population Description

Part A FAS (Participants considered non-responder after rescue treatment use and MI method for missing due to COVID-19); Part B FAS (Participants considered non-responder after rescue treatment use or missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19).

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	39	42	79	81	80
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	7.7; (1.62 to 20.87)	64.3; (48.03 to 78.45)	7.6; (2.84 to 15.80)	79.0; (68.54 to 87.27)	82.5; (72.38 to 90.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	57.5
	Confidence Interval	(2-Sided) 95%; 41.69 to 73.33
	Estimation Comments	Difference is Dupilumab minus Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	72.4
	Confidence Interval	(2-Sided) 95%; 61.05 to 83.70
	Estimation Comments	Difference is Dupilumab minus Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	74.9
	Confidence Interval	(2-Sided) 95%; 64.25 to 85.50
	Estimation Comments	Difference is Dupilumab minus Placebo

9. Secondary Outcome

Title	Normalized Enrichment Score (NES) for the Relative Change From Baseline in the EoE Diagnostic Panel (EDP) at Week 24
Description	NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

Part A FAS (Participants with NES Score in Part A; Last observation carried forward [LOCF] method with data set to missing after rescue treatment use); Part B FAS (Participants with NES Score in Part B; LOCF method with data set to missing after rescue treatment use)

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	29	31	41	44	40
Measure Type: Number; Unit of Measure: Score on a Scale
	-0.160	-2.660	-0.730	-2.675	-2.665

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Wilcoxon rank-sum test
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hodges-Lehmann estimator
	Estimated Value	-2.250
	Confidence Interval	(2-Sided) 95%; -2.7200 to -1.7300
	Estimation Comments	Median Difference is Dupilumab minus Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Wilcoxon rank-sum test
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hodges-Lehmann estimator
	Estimated Value	-1.840
	Confidence Interval	(2-Sided) 95%; -2.4200 to -1.1100
	Estimation Comments	Median Difference is Dupilumab minus Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Wilcoxon rank-sum test
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hodges-Lehmann estimator
	Estimated Value	-1.850
	Confidence Interval	(2-Sided) 95%; -2.4400 to -1.1500
	Estimation Comments	Median Difference is Dupilumab minus Placebo

10. Secondary Outcome

Title	NES for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 24
Description	NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

Part A FAS (Participants with NES Score in Part A; LOCF Method with data set to missing after rescue treatment use); Part B FAS (Participants with NES Score in Part B; LOCF method with data set to missing after rescue treatment use)

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	29	31	41	44	40
Measure Type: Number; Unit of Measure: Score on a Scale
	-0.320	-1.970	-0.640	-1.950	-1.930

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Wilcoxon rank-sum test
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hodges-Lehmann estimator
	Estimated Value	-1.590
	Confidence Interval	(2-Sided) 95%; -1.7400 to -1.2700
	Estimation Comments	Median Difference is Dupilumab minus Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Wilcoxon rank-sum test
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hodges-Lehmann estimator
	Estimated Value	-1.255
	Confidence Interval	(2-Sided) 95%; -1.7300 to -1.0500
	Estimation Comments	Median Difference is Dupilumab minus Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Wilcoxon rank-sum test
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hodges-Lehmann estimator
	Estimated Value	-1.275
	Confidence Interval	(2-Sided) 95%; -1.8200 to -1.0700
	Estimation Comments	Median Difference is Dupilumab minus Placebo

11. Secondary Outcome

Title	Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 24
Description	Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Time Frame	At week 24

Outcome Measure Data

Analysis Population Description

Part A FAS (Participants considered non-responder after rescue treatment use and MI method for missing due to COVID-19); Part B FAS (Participants considered non-responder after rescue treatment use or missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19)

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	39	42	79	81	80
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	0.0; (0.00 to 9.03)	21.4; (10.30 to 36.81)	1.3; (0.03 to 6.85)	27.2; (17.87 to 38.19)	28.8; (19.18 to 39.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0017
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	21.9
	Confidence Interval	(2-Sided) 95%; 9.42 to 34.38
	Estimation Comments	Difference is Dupilumab minus Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	27.6
	Confidence Interval	(2-Sided) 95%; 17.20 to 38.09
	Estimation Comments	Difference is Dupilumab minus Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	28.9
	Confidence Interval	(2-Sided) 95%; 18.36 to 39.46
	Estimation Comments	Difference is Dupilumab minus Placebo

12. Secondary Outcome

Title	Absolute Change From Baseline in Health-related Quality of Life (QoL) Average Score as Measured by EoE Impact Questionnaire (EoE-IQ) at Week 24
Description	The EoE-IQ measures impact of EoE on emotional, social, work & school, & sleep aspects. Participants were asked to respond to 11 questions based on experience living with EoE during past 7 days. Response to each item is on a 5-point scale (1=Not at all [impacted] 2=A little, 3=Somewhat, 4=Quite a bit, 5=Extremely [impacted]). The average score is the sum of non-missing responses divided by the number of items with non-missing responses. The average score can range from 1 to 5; a higher score is indicative of a more negative impact.
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

Part A FAS (MI method with data set to missing after rescue treatment use); Part B FAS (MI method with data set to missing after rescue treatment use)

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	39	42	79	81	80
Least Squares Mean (95% Confidence Interval); Unit of Measure: Score on a Scale
	-0.246; (-0.4659 to -0.0266)	-0.614; (-0.8140 to -0.4149)	-0.578; (-0.6977 to -0.4585)	-0.593; (-0.7152 to -0.4706)	-0.887; (-1.0050 to -0.7685)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0077
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.368
	Confidence Interval	(2-Sided) 95%; -0.6388 to -0.0975
	Estimation Comments	Dupilumab group vs Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8586
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.015
	Confidence Interval	(2-Sided) 95%; -0.1782 to 0.1485
	Estimation Comments	Dupilumab group vs. Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.309
	Confidence Interval	(2-Sided) 95%; -0.4703 to -0.1471
	Estimation Comments	Dupilumab group vs. Placebo

13. Secondary Outcome

Title	Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE Symptom Questionnaire (EoE-SQ) at Week 24
Description	The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the severity of each symptom based on the worst experience in the past 7 days is on a scale of 0 to 10 (higher is worse). The EoE-SQ severity score is calculated as the sum of the severity scores from questions 1 to 3 (chest pain, stomach pain, burning feeling in chest), which could range from 0 to 30; a higher score is indicative of more severe symptoms.
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

Part A FAS (MI method with data set to missing after rescue treatment use); Part B FAS (MI method with data set to missing after rescue treatment use)

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	39	42	79	81	80
Least Squares Mean (95% Confidence Interval); Unit of Measure: Score on a Scale
	-3.9; (-5.46 to -2.31)	-5.8; (-7.24 to -4.44)	-4.0; (-5.16 to -2.80)	-4.5; (-5.59 to -3.32)	-5.4; (-6.60 to 4.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0467
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.87 to -0.03
	Estimation Comments	Dupilumab group vs. Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5469
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.5
	Confidence Interval	95%; -2.03 to 1.08
	Estimation Comments	Dupilumab group vs. Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0718
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.5
	Confidence Interval	(2-Sided) 95%; -3.0 to 0.13
	Estimation Comments	Dupilumab group vs. Placebo

14. Secondary Outcome

Title	Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 24
Description	The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the frequency of each symptom is on a 5-point scale (1 = 'Never', 2 = 'One day', 3 = ' 2-6 days', 4 = 'Once a day', 5 = 'More than once a day'). The EoE-SQ frequency score is calculated as the sum of the frequency scores from the 5 items which could range from 5 to 25; a higher score is indicative of higher frequency of symptoms.
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

Part A FAS (MI method with data set to missing after rescue treatment use); Part B FAS (MI method with data set to missing after rescue treatment use)

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	39	42	79	81	80
Least Squares Mean (95% Confidence Interval); Unit of Measure: Score on a Scale
	-1.7; (-2.67 to -0.71)	-3.4; (-4.29 to -2.53)	-2.6; (-3.25 to -1.87)	-3.0; (-3.69 to -2.36)	-3.9; (-4.61 to -3.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0051
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.7
	Confidence Interval	(2-Sided) 95%; -2.93 to -0.52
	Estimation Comments	Dupilumab group vs. Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3152
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -1.38 to 0.44
	Estimation Comments	Dupilumab group vs. Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0037
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.4
	Confidence Interval	(2-Sided) 95%; -2.30 to 0.45
	Estimation Comments	Dupilumab group vs. Placebo

15. Secondary Outcome

Title	Percentage of Participants Who Received Rescue Treatment During the Placebo-controlled, Double-blind Treatment Period at Week 24
Description	[Not Specified]
Time Frame	At week 24

Outcome Measure Data

Analysis Population Description

Part A FAS; Part B FAS

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	39	42	79	81	80
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	12.8; (4.30 to 27.43)	0.0; (0.00 to 8.41)	2.5; (0.31 to 8.85)	1.2; (0.03 to 6.69)	2.5; (0.30 to 8.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part A: Placebo, Part A: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0170
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-12.7
	Confidence Interval	(2-Sided) 95%; -23.21 to -2.26
	Estimation Comments	Difference is Dupilumab minus Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5493
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-1.3
	Confidence Interval	(2-Sided) 95%; -5.51 to 2.93
	Estimation Comments	Difference is Dupilumab minus Placebo

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part B: Placebo, Part B: Dupilumab 300 mg SC QW
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9887
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -4.9 to 5.02
	Estimation Comments	Difference is Dupilumab minus Placebo

16. Secondary Outcome

Title	Absolute Change From Baseline in Esophageal Distensibility Plateau Measured by Functional Lumen Imaging, if Collected, at Week 24
Description	[Not Specified]
Time Frame	At week 24

Outcome Measure Data

Analysis Population Description

Due to only 7 participants in Part B with change from baseline at week 24 data available across 3 treatment groups, results are not reported to protect the confidentiality of the participants.

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Overall Number of Participants Analyzed	0	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

17. Secondary Outcome

Title	Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 52
Description	Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Time Frame	At week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	30	34	32	37	73	65
Measure Type: Number; Unit of Measure: Percentage of Participants
	60.0	55.9	71.9	67.6	74.0	84.6

18. Secondary Outcome

Title	Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 52
Description	The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Time Frame	Baseline (of previous study part) and week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	23	29	27	24	52	54
Mean (Standard Deviation); Unit of Measure: Score on a Scale
	-21.71 (17.143)	-23.44 (16.149)	-23.69 (13.737)	-27.25 (11.457)	-20.87 (16.387)	-30.26 (15.389)

19. Secondary Outcome

Title	Percent Change in DSQ Total Score at Week 52
Description	The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Time Frame	Baseline (of previous study part) and week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	23	29	27	24	52	54
Mean (Standard Deviation); Unit of Measure: Percentage of Change
	-65.87 (49.705)	-75.93 (36.892)	-71.01 (37.256)	-78.13 (31.003)	-61.19 (44.447)	-80.74 (32.866)

20. Secondary Outcome

Title	Absolute Change in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 52
Description	EoE esophageal characteristics analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.
Time Frame	Baseline (of previous study part) and week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	30	35	31	37	73	63
Median (Standard Deviation); Unit of Measure: Score on a Scale
	-3.9 (2.74)	-4.1 (3.37)	-4.3 (3.21)	-6.1 (3.60)	-5.2 (3.40)	-5.3 (2.85)

21. Secondary Outcome

Title	Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 52
Description	Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). A greater esophageal intraepithelial eosinophil count from baseline indicates worsening disease.
Time Frame	Baseline (of previous study part) and week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	30	34	32	37	73	65
Mean (Standard Deviation); Unit of Measure: Percentage of Change
	-83.76 (24.996)	-88.59 (13.506)	-91.20 (13.037)	-84.21 (42.169)	-84.78 (40.973)	-95.85 (4.037)

22. Secondary Outcome

Title	Absolute Change in EoE Histology Scoring System (EoEHSS) Mean Grade Score at Week 52
Description	Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Time Frame	Baseline (of previous study part) and week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	30	34	32	37	73	65
Mean (Standard Deviation); Unit of Measure: Score on a Scale
	-0.873 (0.5506)	-0.873 (0.3537)	-0.779 (0.4292)	-0.906 (0.3936)	-0.838 (0.4039)	-0.968 (0.4293)

23. Secondary Outcome

Title	Absolute Change in EoEHSS Mean Stage Score at Week 52
Description	Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Time Frame	Baseline (of previous study part) and week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	30	34	32	37	73	65
Mean (Standard Deviation); Unit of Measure: Score on a Scale
	-0.874 (0.4630)	-0.891 (0.2770)	-0.710 (0.3783)	-0.871 (0.3510)	-0.809 (0.3434)	-0.932 (0.3730)

24. Secondary Outcome

Title	Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 52
Description	Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Time Frame	At week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	30	34	32	37	73	65
Measure Type: Number; Unit of Measure: Percentage of Participants
	70.0	82.4	87.5	78.4	83.6	100

25. Secondary Outcome

Title	Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 52
Description	Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Time Frame	At week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	30	34	32	37	73	65
Measure Type: Number; Unit of Measure: Percentage of Participants
	26.7	29.4	40.6	16.2	31.5	30.8

26. Secondary Outcome

Title	Absolute Change in Health-related QOL as Measured by EoE-IQ at Week 52
Description	The EoE-IQ measures impact of EoE on emotional, social, work & school, & sleep aspects. Participants were asked to respond to 11 questions based on experience living with EoE during past 7 days. Response to each item is on a 5-point scale (1=Not at all [impacted] 2=A little, 3=Somewhat, 4=Quite a bit, 5=Extremely [impacted]). The average score is the sum of non-missing responses divided by the number of items with non-missing responses. The average score can range from 1 to 5; a higher score is indicative of a more negative impact.
Time Frame	Baseline (of previous study part) and week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	27	27	31	35	67	56
Mean (Standard Deviation); Unit of Measure: Score on a Scale
	-0.954 (0.6690)	-0.911 (0.6344)	-1.021 (0.7169)	-0.858 (0.6360)	-0.773 (0.6217)	-0.935 (0.6883)

27. Secondary Outcome

Title	Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52
Description	The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the severity of each symptom based on the worst experience in the past 7 days is on a scale of 0 to 10 (higher is worse). The EoE-SQ severity score is calculated as the sum of the severity scores from questions 1 to 3 (chest pain, stomach pain, burning feeling in chest), which could range from 0 to 30; a higher score is indicative of more severe symptoms.
Time Frame	Baseline (of previous study part) and week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	27	27	32	35	68	57
Mean (Standard Deviation); Unit of Measure: Score on a Scale
	-7.2 (6.46)	-5.9 (6.80)	-6.2 (6.42)	-5.9 (6.47)	-4.7 (5.99)	-6.4 (6.86)

28. Secondary Outcome

Title	Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52
Description	The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the frequency of each symptom is on a 5-point scale (1 = 'Never', 2 = 'One day', 3 = ' 2-6 days', 4 = 'Once a day', 5 = 'More than once a day'). The EoE-SQ frequency score is calculated as the sum of the frequency scores from the 5 items which could range from 5 to 25; a higher score is indicative of higher frequency of symptoms.
Time Frame	Baseline (of previous study part) and week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	27	27	32	35	68	57
Mean (Standard Deviation); Unit of Measure: Score on a Scale
	-4.3 (3.78)	-3.2 (3.50)	-4.0 (3.54)	-3.8 (3.62)	-3.6 (3.45)	-4.7 (4.03)

29. Secondary Outcome

Title	Percentage of Participants Who Received Rescue Medication During the 28-week Extended Active Treatment Period
Description	[Not Specified]
Time Frame	Baseline (of Part C) to week 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	37	40	37	37	79	74
Measure Type: Number; Unit of Measure: Percentage of Participants
	8.1	0	2.7	2.7	0	1.4

30. Secondary Outcome

Title	NES for the Relative Change From Baseline in EoE Diagnostic Panel (EDP) at Week 52
Description	NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Time Frame	Baseline (of previous study part) and week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	27	30	17	24	60	49
Median (Full Range); Unit of Measure: Score on a Scale
	-2.580; (-2.87 to -0.45)	-2.670; (-2.83 to -1.09)	-2.28; (-2.8 to -0.8)	-2.62; (-2.9 to -2.1)	-2.64; (-2.9 to 1.2)	-2.69; (-2.9 to -0.6)

31. Secondary Outcome

Title	NES for the Relative Change in the Type 2 Inflammation Signature (T2INF) at Week 52
Description	NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Time Frame	Baseline (of previous study part) and week 52

Outcome Measure Data

Analysis Population Description

Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.

Arm/Group Title	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	27	30	17	24	60	49
Median (Full Range); Unit of Measure: Score on a Scale
	-1.940; (-2.11 to -0.42)	-1.970; (-2.07 to -0.95)	-1.76; (-2.1 to -1.0)	-1.96; (-2.1 to -1.5)	-1.95; (-2.1 to 0.3)	-1.97; (-2.2 to -0.7)

32. Secondary Outcome

Title	Concentration of Functional Dupilumab in Serum at Week 52
Description	[Not Specified]
Time Frame	Baseline (of Part C) up to week 52

Outcome Measure Data

Analysis Population Description

The PK analysis set (PKAS) for Part A and Part C included all randomized participants who received any study drug and who had at least one non-missing drug concentration result following the first dose of study drug in the corresponding study part. The PKAS for Part B and Part C included all randomized participants who received any study drug and who had at least one non-missing drug concentration result following the first dose of study drug in the corresponding study part.

Arm/Group Title		Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:		Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed		34	38	36	37	77	69
Mean (Standard Deviation); Unit of Measure: milligrams per liter (mg/L)
Week 32	Number Analyzed	28 participants	24 participants	31 participants	35 participants	71 participants	58 participants
		101 (44.6)	205 (76.8)	46.0 (33.1)	124 (56.7)	74.0 (42.0)	195 (94.6)
Week 52	Number Analyzed	30 participants	37 participants	33 participants	37 participants	73 participants	66 participants
		137 (81.6)	152 (70.2)	58.6 (36.5)	151 (96.0)	68.9 (45.7)	176 (120)

33. Secondary Outcome

Title	Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response
Description	Number of treatment-emergent ADA responses to dupilumab reported.
Time Frame	Baseline (of previous study part) up to week 52

Outcome Measure Data

Analysis Population Description

ADA analysis set (AAS) Parts A & C: All participants who received any study drug & had at least 1 non-missing ADA result from dupilumab ADA assay after first dose of study drug in corresponding study part (according to treatment actually received); AAS Parts B & C: All participants who received any study drug & had at least 1 non-missing ADA result from dupilumab ADA assay after first dose of study drug in corresponding study part (according to treatment actually received).

Arm/Group Title	Part A: Placebo	Part A: Dupilumab 300 mg SC QW	Part B: Placebo	Part B: Dupilumab 300 mg SC Q2W	Part B: Dupilumab 300 mg SC QW	Part A/C: Placebo / Dupilumab 300 mg QW	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW	Part B/C: Placebo / Dupilumab 300 mg Q2W	Part B/C: Placebo / Dupilumab 300 mg QW	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW
Arm/Group Description:	Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.	Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.	Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Overall Number of Participants Analyzed	39	42	77	77	76	35	39	36	37	77	69
Measure Type: Number; Unit of Measure: Events
	0	0	0	2	1	4	1	1	0	5	0

Adverse Events

Time Frame	From day of first dose up to 12 weeks after end of treatment visit (week 52)
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Part A: Placebo		Part A: Dupilumab 300 mg QW		Part B: Placebo		Part B: Dupilumab 300 mg Q2W		Part B: Dupilumab 300 mg QW		Part C: Dupilumab 300 mg Q2W (Placebo in Part B)		Part C: Dupilumab 300 mg QW (Placebo in Part A or B)		Part C: Dupilumab 300 mg Q2W (Part B Regimen Continued)		Part C: Dupilumab 300 mg QW (Part A or B Regimen Continued)
Arm/Group Description	Participants received placebo matching dupilumab SC during Part A (24-week DBTP). At end of week 24 visit (one-week after last dose of study drug during DBTP), eligible participants from Part A entered into 28-week extended treatment (Part C) and 12-week follow-up. Participants who did not enter into Part C, entered follow-up period.		Participants received dupilumab 300 mg SC QW during Part A (24-week DBTP). At end of week 24 visit (one-week after last dose of study drug during DBTP), eligible participants from Part A entered into 28-week extended treatment (Part C) and 12-week follow-up. Participants who did not enter into Part C, entered follow-up period.		Participants received placebo matching dupilumab SC during Part B (24-week DBTP). At end of week 24 visit (one-week after last dose of study drug during DBTP), eligible participants from Part B entered into 28-week extended treatment (Part C) and 12-week follow-up. Participants who did not enter into Part C, entered follow-up period.		Participants received dupilumab 300 mg Q2W SC during Part B (24-week DBTP). At end of week 24 visit (one-week after last dose of study drug during DBTP), eligible participants from Part B entered into 28-week extended treatment (Part C) and 12-week follow-up. Participants who did not enter into Part C, entered follow-up period.		Participants received dupilumab 300 mg SC QW during Part B (24-week DBTP). At end of week 24 visit (one-week after last dose of study drug during DBTP), eligible participants from Part B entered into 28-week extended treatment (Part C) and 12-week follow-up. Participants who did not enter into Part C, entered follow-up period.		Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.		Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up. Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.		Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.		Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up. Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
All-Cause Mortality
	Part A: Placebo		Part A: Dupilumab 300 mg QW		Part B: Placebo		Part B: Dupilumab 300 mg Q2W		Part B: Dupilumab 300 mg QW		Part C: Dupilumab 300 mg Q2W (Placebo in Part B)		Part C: Dupilumab 300 mg QW (Placebo in Part A or B)		Part C: Dupilumab 300 mg Q2W (Part B Regimen Continued)		Part C: Dupilumab 300 mg QW (Part A or B Regimen Continued)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/39 (0.00%)		0/42 (0.00%)		0/78 (0.00%)		0/81 (0.00%)		0/80 (0.00%)		0/37 (0.00%)		0/74 (0.00%)		0/79 (0.00%)		0/114 (0.00%)
Serious Adverse Events
	Part A: Placebo		Part A: Dupilumab 300 mg QW		Part B: Placebo		Part B: Dupilumab 300 mg Q2W		Part B: Dupilumab 300 mg QW		Part C: Dupilumab 300 mg Q2W (Placebo in Part B)		Part C: Dupilumab 300 mg QW (Placebo in Part A or B)		Part C: Dupilumab 300 mg Q2W (Part B Regimen Continued)		Part C: Dupilumab 300 mg QW (Part A or B Regimen Continued)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/39 (5.13%)		2/42 (4.76%)		1/78 (1.28%)		2/81 (2.47%)		5/80 (6.25%)		1/37 (2.70%)		3/74 (4.05%)		1/79 (1.27%)		4/114 (3.51%)
Gastrointestinal disorders
Abdominal pain † 1	0/39 (0.00%)	0	1/42 (2.38%)	1	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	0/114 (0.00%)	0
Diarrhoea † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	1/114 (0.88%)	1
Rectal tenesmus † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	1/114 (0.88%)	1
Vomiting † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	1/74 (1.35%)	1	0/79 (0.00%)	0	0/114 (0.00%)	0
General disorders
Chest pain † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	1/114 (0.88%)	1
Systemic inflammatory response syndrome † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	1/74 (1.35%)	1	0/79 (0.00%)	0	0/114 (0.00%)	0
Infections and infestations
Campylobacter colitis † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	1/80 (1.25%)	1	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	0/114 (0.00%)	0
Cellulitis † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	1/74 (1.35%)	1	0/79 (0.00%)	0	0/114 (0.00%)	0
Enterocolitis infectious † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	1/114 (0.88%)	1
Pneumonia aspiration † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	1/80 (1.25%)	1	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	0/114 (0.00%)	0
Pneumonia mycoplasmal † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	1/114 (0.88%)	1
Injury, poisoning and procedural complications
Open globe injury † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	1/37 (2.70%)	1	0/74 (0.00%)	0	0/79 (0.00%)	0	0/114 (0.00%)	0
Investigations
Blood creatine phosphokinase abnormal † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	1/80 (1.25%)	1	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	0/114 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	1/80 (1.25%)	1	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	0/114 (0.00%)	0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous † 1	1/39 (2.56%)	1	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	0/114 (0.00%)	0
Psychiatric disorders
Suicidal ideation † 1	1/39 (2.56%)	1	0/42 (0.00%)	0	0/78 (0.00%)	0	2/81 (2.47%)	2	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	0/114 (0.00%)	0
Depression suicidal † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	1/80 (1.25%)	1	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	0/114 (0.00%)	0
Mental status changes † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	1/78 (1.28%)	1	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	0/114 (0.00%)	0
Generalised anxiety disorder † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	1/79 (1.27%)	1	0/114 (0.00%)	0
Substance use disorder † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	1/79 (1.27%)	1	0/114 (0.00%)	0
Reproductive system and breast disorders
Uterine polyp † 1	0/39 (0.00%)	0	1/42 (2.38%)	1	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	0/114 (0.00%)	0
1 Term from vocabulary, MedDRA (25.0); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Part A: Placebo		Part A: Dupilumab 300 mg QW		Part B: Placebo		Part B: Dupilumab 300 mg Q2W		Part B: Dupilumab 300 mg QW		Part C: Dupilumab 300 mg Q2W (Placebo in Part B)		Part C: Dupilumab 300 mg QW (Placebo in Part A or B)		Part C: Dupilumab 300 mg Q2W (Part B Regimen Continued)		Part C: Dupilumab 300 mg QW (Part A or B Regimen Continued)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/39 (71.79%)		26/42 (61.90%)		41/78 (52.56%)		57/81 (70.37%)		50/80 (62.50%)		19/37 (51.35%)		44/74 (59.46%)		47/79 (59.49%)		62/114 (54.39%)
Gastrointestinal disorders
Nausea † 1	3/39 (7.69%)	4	1/42 (2.38%)	2	7/78 (8.97%)	7	4/81 (4.94%)	4	5/80 (6.25%)	5	2/37 (5.41%)	3	1/74 (1.35%)	1	2/79 (2.53%)	2	4/114 (3.51%)	4
Abdominal pain † 1	2/39 (5.13%)	3	1/42 (2.38%)	1	4/78 (5.13%)	4	2/81 (2.47%)	2	4/80 (5.00%)	4	0/37 (0.00%)	0	0/74 (0.00%)	0	2/79 (2.53%)	2	4/114 (3.51%)	4
Diarrhoea † 1	2/39 (5.13%)	2	2/42 (4.76%)	2	8/78 (10.26%)	12	3/81 (3.70%)	4	1/80 (1.25%)	1	2/37 (5.41%)	2	2/74 (2.70%)	2	2/79 (2.53%)	2	0/114 (0.00%)	0
Dysphagia † 1	2/39 (5.13%)	2	0/42 (0.00%)	0	0/78 (0.00%)	0	1/81 (1.23%)	1	2/80 (2.50%)	2	1/37 (2.70%)	1	1/74 (1.35%)	2	4/79 (5.06%)	4	4/114 (3.51%)	4
Vomiting † 1	1/39 (2.56%)	1	2/42 (4.76%)	2	4/78 (5.13%)	6	3/81 (3.70%)	5	3/80 (3.75%)	3	1/37 (2.70%)	1	3/74 (4.05%)	4	2/79 (2.53%)	2	4/114 (3.51%)	4
Dyspepsia † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	4/78 (5.13%)	9	2/81 (2.47%)	2	0/80 (0.00%)	0	0/37 (0.00%)	0	4/74 (5.41%)	6	2/79 (2.53%)	2	4/114 (3.51%)	6
Eosinophilic oesophagitis † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	4/37 (10.81%)	4	0/74 (0.00%)	0	0/79 (0.00%)	0	0/114 (0.00%)	0
General disorders
Injection site erythema † 1	6/39 (15.38%)	22	4/42 (9.52%)	12	9/78 (11.54%)	42	18/81 (22.22%)	93	8/80 (10.00%)	25	2/37 (5.41%)	32	6/74 (8.11%)	13	6/79 (7.59%)	36	10/114 (8.77%)	21
Injection site reaction † 1	5/39 (12.82%)	19	9/42 (21.43%)	45	16/78 (20.51%)	69	18/81 (22.22%)	75	16/80 (20.00%)	84	3/37 (8.11%)	4	12/74 (16.22%)	40	14/79 (17.72%)	50	14/114 (12.28%)	101
Injection site pain † 1	3/39 (7.69%)	6	5/42 (11.90%)	9	4/78 (5.13%)	21	10/81 (12.35%)	45	7/80 (8.75%)	39	4/37 (10.81%)	34	6/74 (8.11%)	7	6/79 (7.59%)	66	9/114 (7.89%)	45
Injection site oedema † 1	2/39 (5.13%)	2	2/42 (4.76%)	7	3/78 (3.85%)	7	4/81 (4.94%)	4	0/80 (0.00%)	0	0/37 (0.00%)	0	3/74 (4.05%)	12	3/79 (3.80%)	12	3/114 (2.63%)	8
Injection site pruritus † 1	2/39 (5.13%)	2	1/42 (2.38%)	1	3/78 (3.85%)	5	1/81 (1.23%)	6	4/80 (5.00%)	5	1/37 (2.70%)	6	1/74 (1.35%)	1	3/79 (3.80%)	8	0/114 (0.00%)	0
Injection site bruising † 1	1/39 (2.56%)	2	1/42 (2.38%)	2	0/78 (0.00%)	0	6/81 (7.41%)	7	0/80 (0.00%)	0	1/37 (2.70%)	4	4/74 (5.41%)	4	1/79 (1.27%)	4	3/114 (2.63%)	3
Injection site swelling † 1	1/39 (2.56%)	5	5/42 (11.90%)	7	2/78 (2.56%)	10	7/81 (8.64%)	12	10/80 (12.50%)	25	4/37 (10.81%)	4	0/74 (0.00%)	0	2/79 (2.53%)	4	4/114 (3.51%)	27
Pyrexia † 1	1/39 (2.56%)	1	2/42 (4.76%)	2	1/78 (1.28%)	1	3/81 (3.70%)	3	5/80 (6.25%)	5	0/37 (0.00%)	0	0/74 (0.00%)	0	1/79 (1.27%)	1	2/114 (1.75%)	2
Fatigue † 1	0/39 (0.00%)	0	1/42 (2.38%)	1	4/78 (5.13%)	20	2/81 (2.47%)	2	5/80 (6.25%)	5	1/37 (2.70%)	1	1/74 (1.35%)	1	1/79 (1.27%)	1	2/114 (1.75%)	2
Injection site urticaria † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	2/78 (2.56%)	4	6/81 (7.41%)	9	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	2/79 (2.53%)	5	0/114 (0.00%)	0
Immune system disorders
Food allergy † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	1/81 (1.23%)	1	0/80 (0.00%)	0	2/37 (5.41%)	2	0/74 (0.00%)	0	1/79 (1.27%)	1	2/114 (1.75%)	2
Infections and infestations
Nasopharyngitis † 1	4/39 (10.26%)	4	5/42 (11.90%)	6	3/78 (3.85%)	4	4/81 (4.94%)	5	2/80 (2.50%)	2	2/37 (5.41%)	2	7/74 (9.46%)	8	2/79 (2.53%)	3	5/114 (4.39%)	6
Sinusitis † 1	2/39 (5.13%)	2	1/42 (2.38%)	1	0/78 (0.00%)	0	0/81 (0.00%)	0	4/80 (5.00%)	5	0/37 (0.00%)	0	2/74 (2.70%)	2	2/79 (2.53%)	2	1/114 (0.88%)	1
COVID-19 † 1	1/39 (2.56%)	1	0/42 (0.00%)	0	0/78 (0.00%)	0	5/81 (6.17%)	5	4/80 (5.00%)	4	1/37 (2.70%)	1	7/74 (9.46%)	7	8/79 (10.13%)	8	10/114 (8.77%)	10
Upper respiratory tract infection † 1	0/39 (0.00%)	0	4/42 (9.52%)	4	2/78 (2.56%)	2	2/81 (2.47%)	2	3/80 (3.75%)	4	0/37 (0.00%)	0	2/74 (2.70%)	2	0/79 (0.00%)	0	6/114 (5.26%)	7
Injury, poisoning and procedural complications
Vaccination complication † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	0/78 (0.00%)	0	0/81 (0.00%)	0	2/80 (2.50%)	2	0/37 (0.00%)	0	1/74 (1.35%)	1	4/79 (5.06%)	4	2/114 (1.75%)	2
Investigations
Blood creatine phosphokinase increased † 1	2/39 (5.13%)	2	0/42 (0.00%)	0	1/78 (1.28%)	1	1/81 (1.23%)	1	3/80 (3.75%)	3	4/37 (10.81%)	6	3/74 (4.05%)	3	2/79 (2.53%)	2	2/114 (1.75%)	3
Nervous system disorders
Headache † 1	4/39 (10.26%)	11	2/42 (4.76%)	7	9/78 (11.54%)	28	5/81 (6.17%)	10	7/80 (8.75%)	8	2/37 (5.41%)	6	4/74 (5.41%)	9	4/79 (5.06%)	6	5/114 (4.39%)	8
Psychiatric disorders
Anxiety † 1	0/39 (0.00%)	0	0/42 (0.00%)	0	1/78 (1.28%)	1	2/81 (2.47%)	2	3/80 (3.75%)	3	1/37 (2.70%)	1	4/74 (5.41%)	4	1/79 (1.27%)	1	4/114 (3.51%)	5
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain † 1	2/39 (5.13%)	2	0/42 (0.00%)	0	6/78 (7.69%)	7	5/81 (6.17%)	6	4/80 (5.00%)	4	0/37 (0.00%)	0	0/74 (0.00%)	0	2/79 (2.53%)	2	1/114 (0.88%)	1
Rhinitis allergic † 1	2/39 (5.13%)	2	1/42 (2.38%)	1	2/78 (2.56%)	2	1/81 (1.23%)	1	2/80 (2.50%)	2	0/37 (0.00%)	0	3/74 (4.05%)	3	0/79 (0.00%)	0	1/114 (0.88%)	1
Rhinorrhoea † 1	0/39 (0.00%)	0	3/42 (7.14%)	3	0/78 (0.00%)	0	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	0/74 (0.00%)	0	0/79 (0.00%)	0	1/114 (0.88%)	1
Skin and subcutaneous tissue disorders
Dermatitis atopic † 1	4/39 (10.26%)	5	0/42 (0.00%)	0	1/78 (1.28%)	1	0/81 (0.00%)	0	0/80 (0.00%)	0	0/37 (0.00%)	0	1/74 (1.35%)	1	1/79 (1.27%)	1	2/114 (1.75%)	2
Rash † 1	4/39 (10.26%)	4	0/42 (0.00%)	0	0/78 (0.00%)	0	4/81 (4.94%)	4	3/80 (3.75%)	3	1/37 (2.70%)	1	0/74 (0.00%)	0	2/79 (2.53%)	2	7/114 (6.14%)	9
Acne † 1	1/39 (2.56%)	1	0/42 (0.00%)	0	3/78 (3.85%)	3	2/81 (2.47%)	3	0/80 (0.00%)	0	2/37 (5.41%)	2	4/74 (5.41%)	4	2/79 (2.53%)	2	2/114 (1.75%)	2
Vascular disorders
Hypertension † 1	0/39 (0.00%)	0	1/42 (2.38%)	1	1/78 (1.28%)	1	1/81 (1.23%)	1	4/80 (5.00%)	5	0/37 (0.00%)	0	0/74 (0.00%)	0	1/79 (1.27%)	1	2/114 (1.75%)	2
1 Term from vocabulary, MedDRA (25.0); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.
• Phone: 844-734-6643
• EMail: clinicaltrials@regeneron.com

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03633617
• Other Study ID Numbers: R668-EE-1774; 2018-000844-25 ( EudraCT Number )
• First Submitted: August 14, 2018
• First Posted: August 16, 2018
• Results First Submitted: September 4, 2022
• Results First Posted: December 28, 2022
• Last Update Posted: June 28, 2023