Trial Outcomes & Findings for Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE) (NCT NCT03633617)

Results Overview

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

321 participants

Primary outcome timeframe

At week 24

Results posted on

2023-06-28

Participant Flow

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).

Participant milestones

Participant milestones
Measure	Part A: Placebo 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.	Part A: Dupilumab 300 mg SC QW 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.	Part B: Placebo 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.	Part B: Dupilumab 300 mg SC Q2W 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.	Part B: Dupilumab 300 mg SC QW 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.	Part A/C: Placebo / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Part A STARTED	39	42	0	0	0	0	0	0	0	0	0
Part A COMPLETED	36	37	0	0	0	0	0	0	0	0	0
Part A NOT COMPLETED	3	5	0	0	0	0	0	0	0	0	0
Part B STARTED	0	0	79	81	80	0	0	0	0	0	0
Part B COMPLETED	0	0	74	79	75	0	0	0	0	0	0
Part B NOT COMPLETED	0	0	5	2	5	0	0	0	0	0	0
Part C (& Follow-up) STARTED	0	0	0	0	0	37	40	37	37	79	74
Part C (& Follow-up) Completed Week 52 (End of Treatment)	0	0	0	0	0	32	38	34	36	74	65
Part C (& Follow-up) COMPLETED	0	0	0	0	0	30	35	33	36	67	64
Part C (& Follow-up) NOT COMPLETED	0	0	0	0	0	7	5	4	1	12	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Placebo 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.	Part A: Dupilumab 300 mg SC QW 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.	Part B: Placebo 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.	Part B: Dupilumab 300 mg SC Q2W 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.	Part B: Dupilumab 300 mg SC QW 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.	Part A/C: Placebo / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Part A Week 24 not performed due to Coronavirus Disease-2019 (COVID-19)	1	3	0	0	0	0	0	0	0	0	0
Part A Unconfirmed early termination visit	1	0	0	0	0	0	0	0	0	0	0
Part A Adverse Event	0	1	0	0	0	0	0	0	0	0	0
Part A Pregnancy	1	0	0	0	0	0	0	0	0	0	0
Part A Withdrawal by Subject	0	1	0	0	0	0	0	0	0	0	0
Part B Adverse Event	0	0	2	2	1	0	0	0	0	0	0
Part B Withdrawal by Subject	0	0	1	0	2	0	0	0	0	0	0
Part B Lost to Follow-up	0	0	0	0	1	0	0	0	0	0	0
Part B Physician Decision	0	0	0	0	1	0	0	0	0	0	0
Part B COVID-19 Restrictions	0	0	1	0	0	0	0	0	0	0	0
Part B Subject randomized, but did not receive study drug; did not qualify for study	0	0	1	0	0	0	0	0	0	0	0
Part C (& Follow-up) Adverse Event	0	0	0	0	0	1	0	1	0	0	0
Part C (& Follow-up) Pregnancy	0	0	0	0	0	0	0	0	0	1	0
Part C (& Follow-up) Withdrawal by Subject	0	0	0	0	0	2	2	0	1	1	6
Part C (& Follow-up) Lost to Follow-up	0	0	0	0	0	3	3	1	0	7	2
Part C (& Follow-up) Physician Decision	0	0	0	0	0	0	0	1	0	0	1
Part C (& Follow-up) COVID-19 related	0	0	0	0	0	1	0	0	0	0	0
Part C (& Follow-up) Protocol Violation	0	0	0	0	0	0	0	0	0	3	1
Part C (& Follow-up) Lack of Efficacy	0	0	0	0	0	0	0	1	0	0	0

Baseline Characteristics

Part A Full Analysis Set (FAS): All randomized participants in Part A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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 n=321 Participants Total of all reporting groups
Age, Customized ≥ 12 to < 18 years old	9 Participants n=39 Participants • Part A Full Analysis Set (FAS): All randomized participants in Part A	11 Participants n=42 Participants • Part A Full Analysis Set (FAS): All randomized participants in Part A	26 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	27 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	26 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	79 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Age, Customized ≥ 18 to < 40 years old	22 Participants n=39 Participants • Part A Full Analysis Set (FAS): All randomized participants in Part A	13 Participants n=42 Participants • Part A Full Analysis Set (FAS): All randomized participants in Part A	38 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	35 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	38 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	111 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Age, Customized ≥ 40 to < 65 years old	8 Participants n=39 Participants • Part A Full Analysis Set (FAS): All randomized participants in Part A	18 Participants n=42 Participants • Part A Full Analysis Set (FAS): All randomized participants in Part A	15 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	18 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	15 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	48 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Age, Customized ≥ 65 years old	0 Participants n=39 Participants • Part A Full Analysis Set (FAS): All randomized participants in Part A	0 Participants n=42 Participants • Part A Full Analysis Set (FAS): All randomized participants in Part A	0 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	1 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	1 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	2 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Sex: Female, Male Female	18 Participants n=39 Participants • Part A FAS: All randomized participants in Part A	14 Participants n=42 Participants • Part A FAS: All randomized participants in Part A	21 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	36 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	30 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	87 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Sex: Female, Male Male	21 Participants n=39 Participants • Part A FAS: All randomized participants in Part A	28 Participants n=42 Participants • Part A FAS: All randomized participants in Part A	58 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	45 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	50 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	153 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=39 Participants • Part A FAS: All randomized participants in Part A	4 Participants n=42 Participants • Part A FAS: All randomized participants in Part A	5 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	3 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	5 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	13 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=39 Participants • Part A FAS: All randomized participants in Part A	38 Participants n=42 Participants • Part A FAS: All randomized participants in Part A	74 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	77 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	75 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	226 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants • Part A FAS: All randomized participants in Part A	0 Participants n=42 Participants • Part A FAS: All randomized participants in Part A	0 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	1 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	0 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	1 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Race/Ethnicity, Customized White	37 Participants n=39 Participants • Part A FAS: All randomized participants in Part A	41 Participants n=42 Participants • Part A FAS: All randomized participants in Part A	72 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	74 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	71 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	217 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Race/Ethnicity, Customized Black or African American	1 Participants n=39 Participants • Part A FAS: All randomized participants in Part A	1 Participants n=42 Participants • Part A FAS: All randomized participants in Part A	3 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	3 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	2 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	8 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Race/Ethnicity, Customized Asian	0 Participants n=39 Participants • Part A FAS: All randomized participants in Part A	0 Participants n=42 Participants • Part A FAS: All randomized participants in Part A	1 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	1 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	3 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	5 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Race/Ethnicity, Customized Other	1 Participants n=39 Participants • Part A FAS: All randomized participants in Part A	0 Participants n=42 Participants • Part A FAS: All randomized participants in Part A	2 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	2 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	3 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	7 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Race/Ethnicity, Customized Not reported	0 Participants n=39 Participants • Part A FAS: All randomized participants in Part A	0 Participants n=42 Participants • Part A FAS: All randomized participants in Part A	1 Participants n=79 Participants • Part B FAS: All randomized participants in Part B	1 Participants n=81 Participants • Part B FAS: All randomized participants in Part B	1 Participants n=80 Participants • Part B FAS: All randomized participants in Part B	3 Participants n=240 Participants • Part B FAS: All randomized participants in Part B
Part A: Dysphagia Symptom Questionnaire (DSQ) Total Score	35.1 Score on a Scale STANDARD_DEVIATION 12.11 • n=39 Participants • Part A FAS: All randomized participants in Part A	32.2 Score on a Scale STANDARD_DEVIATION 12.66 • n=42 Participants • Part A FAS: All randomized participants in Part A	—	—	—	33.6 Score on a Scale STANDARD_DEVIATION 12.41 • n=81 Participants • Part A FAS: All randomized participants in Part A
Part B: Dysphagia Symptom Questionnaire (DSQ) Total Score	—	—	36.1 Score on a Scale STANDARD_DEVIATION 10.55 • n=79 Participants • Part B FAS: All randomized participants in Part B	35.6 Score on a Scale STANDARD_DEVIATION 12.24 • n=81 Participants • Part B FAS: All randomized participants in Part B	38.4 Score on a Scale STANDARD_DEVIATION 10.70 • n=80 Participants • Part B FAS: All randomized participants in Part B	36.7 Score on a Scale STANDARD_DEVIATION 11.22 • n=240 Participants • Part B FAS: All randomized participants in Part B
Part A: Peak Eosinophils (eos) Count of Three Regions per High-power Field (/hpf)	96.5 Eosinophils/high-power field (eos/hpf) STANDARD_DEVIATION 54.69 • n=39 Participants • Part A FAS: All randomized participants in Part A	82.6 Eosinophils/high-power field (eos/hpf) STANDARD_DEVIATION 41.02 • n=42 Participants • Part A FAS: All randomized participants in Part A	—	—	—	89.3 Eosinophils/high-power field (eos/hpf) STANDARD_DEVIATION 48.29 • n=81 Participants • Part A FAS: All randomized participants in Part A
Part B: Peak Eosinophils (eos) Count of Three Regions per High-power Field (/hpf)	—	—	84.3 Eosinophils/high-power field (eos/hpf) STANDARD_DEVIATION 41.20 • n=79 Participants • Part B FAS: All randomized participants in Part B	87.7 Eosinophils/high-power field (eos/hpf) STANDARD_DEVIATION 49.37 • n=81 Participants • Part B FAS: All randomized participants in Part B	89.2 Eosinophils/high-power field (eos/hpf) STANDARD_DEVIATION 46.67 • n=80 Participants • Part B FAS: All randomized participants in Part B	87.1 Eosinophils/high-power field (eos/hpf) STANDARD_DEVIATION 45.76 • n=240 Participants • Part B FAS: All randomized participants in Part B
Part A: Eosinophilic Esophagitis (EoE) Histological Grade Calculated Mean Score (0 - 3)	1.324 Score on a Scale STANDARD_DEVIATION 0.4676 • n=39 Participants • Part A FAS: All randomized participants in Part A	1.260 Score on a Scale STANDARD_DEVIATION 0.4088 • n=42 Participants • Part A FAS: All randomized participants in Part A	—	—	—	1.291 Score on a Scale STANDARD_DEVIATION 0.4365 • n=81 Participants • Part A FAS: All randomized participants in Part A
Part B: Eosinophilic Esophagitis (EoE) Histological Grade Calculated Mean Score (0 - 3)	—	—	1.226 Score on a Scale STANDARD_DEVIATION 0.3996 • n=79 Participants • Part B FAS: All randomized participants in Part B	1.245 Score on a Scale STANDARD_DEVIATION 0.3721 • n=81 Participants • Part B FAS: All randomized participants in Part B	1.305 Score on a Scale STANDARD_DEVIATION 0.3882 • n=80 Participants • Part B FAS: All randomized participants in Part B	1.259 Score on a Scale STANDARD_DEVIATION 0.3865 • n=240 Participants • Part B FAS: All randomized participants in Part B
Part A: Eosinophilic Esophagitis (EoE) Histological Stage Calculated Mean Score (0 - 3)	1.376 Score on a Scale STANDARD_DEVIATION 0.3972 • n=39 Participants • Part A FAS: All randomized participants in Part A	1.299 Score on a Scale STANDARD_DEVIATION 0.3334 • n=42 Participants • Part A FAS: All randomized participants in Part A	—	—	—	1.336 Score on a Scale STANDARD_DEVIATION 0.3653 • n=81 Participants • Part A FAS: All randomized participants in Part A
Part B: Eosinophilic Esophagitis (EoE) Histological Stage Calculated Mean Score (0 - 3)	—	—	1.216 Score on a Scale STANDARD_DEVIATION 0.3608 • n=79 Participants • Part B FAS: All randomized participants in Part B	1.248 Score on a Scale STANDARD_DEVIATION 0.3182 • n=81 Participants • Part B FAS: All randomized participants in Part B	1.294 Score on a Scale STANDARD_DEVIATION 0.3256 • n=80 Participants • Part B FAS: All randomized participants in Part B	1.253 Score on a Scale STANDARD_DEVIATION 0.3353 • n=240 Participants • Part B FAS: All randomized participants in Part B

PRIMARY outcome

Timeframe: At week 24

Population: 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)

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
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	5.1 Percentage of Participants Interval 0.63 to 17.32	59.5 Percentage of Participants Interval 43.28 to 74.37	6.3 Percentage of Participants Interval 2.09 to 14.16	60.5 Percentage of Participants Interval 49.01 to 71.19	58.8 Percentage of Participants Interval 47.18 to 69.65	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and week 24

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24	-9.60 Score on a Scale Interval -15.056 to -4.136	-21.92 Score on a Scale Interval -26.87 to -16.967	-13.86 Score on a Scale Interval -17.605 to -10.12	-14.37 Score on a Scale Interval -18.018 to -10.723	-23.78 Score on a Scale Interval -27.427 to -20.131	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 24

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 24	-2.98 Percentage of Change Interval -17.886 to 11.921	-71.24 Percentage of Change Interval -84.863 to -57.613	8.38 Percentage of Change Interval -11.677 to 28.433	-70.84 Percentage of Change Interval -87.095 to -54.585	-80.24 Percentage of Change Interval -96.589 to -63.895	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 24

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Percent Change From Baseline in DSQ Total Score at Week 24	-31.68 Percentage of Change Interval -47.545 to -15.818	-69.17 Percentage of Change Interval -83.578 to -54.752	-41.43 Percentage of Change Interval -51.749 to -31.116	-45.78 Percentage of Change Interval -55.658 to -35.904	-64.32 Percentage of Change Interval -74.267 to 54.382	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 24

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change From Baseline in Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Mean Grade Score at Week 24	-0.001 Score on a Scale Interval -0.1166 to 0.1139	-0.761 Score on a Scale Interval -0.8732 to -0.6484	-0.148 Score on a Scale Interval -0.2379 to -0.0584	-0.814 Score on a Scale Interval -0.8958 to -0.7317	-0.830 Score on a Scale Interval -0.9136 to -0.7463	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 24

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change From Baseline in EoEHSS Mean Stage Score at Week 24	-0.012 Score on a Scale Interval -0.1243 to 0.0995	-0.753 Score on a Scale Interval -0.8627 to -0.6441	-0.132 Score on a Scale Interval -0.2179 to -0.0464	-0.793 Score on a Scale Interval -0.8713 to -0.7144	-0.804 Score on a Scale Interval -0.8839 to -0.7237	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 24

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 24	-0.3 Score on a Scale Interval -1.11 to 0.5	-3.2 Score on a Scale Interval -3.98 to -2.38	-0.6 Score on a Scale Interval -1.37 to 0.12	-4.6 Score on a Scale Interval -5.24 to -3.89	-4.5 Score on a Scale Interval -5.17 to -3.77	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At week 24

Population: 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).

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 24	7.7 Percentage of Participants Interval 1.62 to 20.87	64.3 Percentage of Participants Interval 48.03 to 78.45	7.6 Percentage of Participants Interval 2.84 to 15.8	79.0 Percentage of Participants Interval 68.54 to 87.27	82.5 Percentage of Participants Interval 72.38 to 90.09	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 24

Population: 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)

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).

Outcome measures

Outcome measures
Measure	Part A: Placebo n=29 Participants 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.	Part A: Dupilumab 300 mg SC QW n=31 Participants 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.	Part B: Placebo n=41 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=44 Participants 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.	Part B: Dupilumab 300 mg SC QW n=40 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Normalized Enrichment Score (NES) for the Relative Change From Baseline in the EoE Diagnostic Panel (EDP) at Week 24	-0.160 Score on a Scale	-2.660 Score on a Scale	-0.730 Score on a Scale	-2.675 Score on a Scale	-2.665 Score on a Scale	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 24

Population: 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)

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).

Outcome measures

Outcome measures
Measure	Part A: Placebo n=29 Participants 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.	Part A: Dupilumab 300 mg SC QW n=31 Participants 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.	Part B: Placebo n=41 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=44 Participants 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.	Part B: Dupilumab 300 mg SC QW n=40 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
NES for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 24	-0.320 Score on a Scale	-1.970 Score on a Scale	-0.640 Score on a Scale	-1.950 Score on a Scale	-1.930 Score on a Scale	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At week 24

Population: 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)

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 24	0.0 Percentage of Participants Interval 0.0 to 9.03	21.4 Percentage of Participants Interval 10.3 to 36.81	1.3 Percentage of Participants Interval 0.03 to 6.85	27.2 Percentage of Participants Interval 17.87 to 38.19	28.8 Percentage of Participants Interval 19.18 to 39.95	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 24

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change From Baseline in Health-related Quality of Life (QoL) Average Score as Measured by EoE Impact Questionnaire (EoE-IQ) at Week 24	-0.246 Score on a Scale Interval -0.4659 to -0.0266	-0.614 Score on a Scale Interval -0.814 to -0.4149	-0.578 Score on a Scale Interval -0.6977 to -0.4585	-0.593 Score on a Scale Interval -0.7152 to -0.4706	-0.887 Score on a Scale Interval -1.005 to -0.7685	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 24

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE Symptom Questionnaire (EoE-SQ) at Week 24	-3.9 Score on a Scale Interval -5.46 to -2.31	-5.8 Score on a Scale Interval -7.24 to -4.44	-4.0 Score on a Scale Interval -5.16 to -2.8	-4.5 Score on a Scale Interval -5.59 to -3.32	-5.4 Score on a Scale Interval -6.6 to 4.27	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 24

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 24	-1.7 Score on a Scale Interval -2.67 to -0.71	-3.4 Score on a Scale Interval -4.29 to -2.53	-2.6 Score on a Scale Interval -3.25 to -1.87	-3.0 Score on a Scale Interval -3.69 to -2.36	-3.9 Score on a Scale Interval -4.61 to -3.25	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At week 24

Population: Part A FAS; Part B FAS

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=79 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=81 Participants 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.	Part B: Dupilumab 300 mg SC QW n=80 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Percentage of Participants Who Received Rescue Treatment During the Placebo-controlled, Double-blind Treatment Period at Week 24	12.8 Percentage of Participants Interval 4.3 to 27.43	0.0 Percentage of Participants Interval 0.0 to 8.41	2.5 Percentage of Participants Interval 0.31 to 8.85	1.2 Percentage of Participants Interval 0.03 to 6.69	2.5 Percentage of Participants Interval 0.3 to 8.74	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At week 24

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At week 52

Population: 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.

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Outcome measures

Outcome measures
Measure	Part A: Placebo n=30 Participants 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.	Part A: Dupilumab 300 mg SC QW n=34 Participants 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.	Part B: Placebo n=32 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=37 Participants 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.	Part B: Dupilumab 300 mg SC QW n=73 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=65 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
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	60.0 Percentage of Participants	55.9 Percentage of Participants	71.9 Percentage of Participants	67.6 Percentage of Participants	74.0 Percentage of Participants	84.6 Percentage of Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of previous study part) and week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=23 Participants 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.	Part A: Dupilumab 300 mg SC QW n=29 Participants 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.	Part B: Placebo n=27 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=24 Participants 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.	Part B: Dupilumab 300 mg SC QW n=52 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=54 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 52	-21.71 Score on a Scale Standard Deviation 17.143	-23.44 Score on a Scale Standard Deviation 16.149	-23.69 Score on a Scale Standard Deviation 13.737	-27.25 Score on a Scale Standard Deviation 11.457	-20.87 Score on a Scale Standard Deviation 16.387	-30.26 Score on a Scale Standard Deviation 15.389	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of previous study part) and week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=23 Participants 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.	Part A: Dupilumab 300 mg SC QW n=29 Participants 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.	Part B: Placebo n=27 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=24 Participants 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.	Part B: Dupilumab 300 mg SC QW n=52 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=54 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Percent Change in DSQ Total Score at Week 52	-65.87 Percentage of Change Standard Deviation 49.705	-75.93 Percentage of Change Standard Deviation 36.892	-71.01 Percentage of Change Standard Deviation 37.256	-78.13 Percentage of Change Standard Deviation 31.003	-61.19 Percentage of Change Standard Deviation 44.447	-80.74 Percentage of Change Standard Deviation 32.866	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of previous study part) and week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=30 Participants 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.	Part A: Dupilumab 300 mg SC QW n=35 Participants 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.	Part B: Placebo n=31 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=37 Participants 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.	Part B: Dupilumab 300 mg SC QW n=73 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=63 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 52	-3.9 Score on a Scale Standard Deviation 2.74	-4.1 Score on a Scale Standard Deviation 3.37	-4.3 Score on a Scale Standard Deviation 3.21	-6.1 Score on a Scale Standard Deviation 3.60	-5.2 Score on a Scale Standard Deviation 3.40	-5.3 Score on a Scale Standard Deviation 2.85	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of previous study part) and week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=30 Participants 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.	Part A: Dupilumab 300 mg SC QW n=34 Participants 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.	Part B: Placebo n=32 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=37 Participants 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.	Part B: Dupilumab 300 mg SC QW n=73 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=65 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 52	-83.76 Percentage of Change Standard Deviation 24.996	-88.59 Percentage of Change Standard Deviation 13.506	-91.20 Percentage of Change Standard Deviation 13.037	-84.21 Percentage of Change Standard Deviation 42.169	-84.78 Percentage of Change Standard Deviation 40.973	-95.85 Percentage of Change Standard Deviation 4.037	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of previous study part) and week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=30 Participants 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.	Part A: Dupilumab 300 mg SC QW n=34 Participants 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.	Part B: Placebo n=32 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=37 Participants 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.	Part B: Dupilumab 300 mg SC QW n=73 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=65 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change in EoE Histology Scoring System (EoEHSS) Mean Grade Score at Week 52	-0.873 Score on a Scale Standard Deviation 0.5506	-0.873 Score on a Scale Standard Deviation 0.3537	-0.779 Score on a Scale Standard Deviation 0.4292	-0.906 Score on a Scale Standard Deviation 0.3936	-0.838 Score on a Scale Standard Deviation 0.4039	-0.968 Score on a Scale Standard Deviation 0.4293	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of previous study part) and week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=30 Participants 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.	Part A: Dupilumab 300 mg SC QW n=34 Participants 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.	Part B: Placebo n=32 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=37 Participants 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.	Part B: Dupilumab 300 mg SC QW n=73 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=65 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change in EoEHSS Mean Stage Score at Week 52	-0.874 Score on a Scale Standard Deviation 0.4630	-0.891 Score on a Scale Standard Deviation 0.2770	-0.710 Score on a Scale Standard Deviation 0.3783	-0.871 Score on a Scale Standard Deviation 0.3510	-0.809 Score on a Scale Standard Deviation 0.3434	-0.932 Score on a Scale Standard Deviation 0.3730	—	—	—	—	—

SECONDARY outcome

Timeframe: At week 52

Population: 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.

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Outcome measures

Outcome measures
Measure	Part A: Placebo n=30 Participants 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.	Part A: Dupilumab 300 mg SC QW n=34 Participants 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.	Part B: Placebo n=32 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=37 Participants 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.	Part B: Dupilumab 300 mg SC QW n=73 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=65 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 52	70.0 Percentage of Participants	82.4 Percentage of Participants	87.5 Percentage of Participants	78.4 Percentage of Participants	83.6 Percentage of Participants	100 Percentage of Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: At week 52

Population: 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.

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Outcome measures

Outcome measures
Measure	Part A: Placebo n=30 Participants 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.	Part A: Dupilumab 300 mg SC QW n=34 Participants 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.	Part B: Placebo n=32 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=37 Participants 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.	Part B: Dupilumab 300 mg SC QW n=73 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=65 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 52	26.7 Percentage of Participants	29.4 Percentage of Participants	40.6 Percentage of Participants	16.2 Percentage of Participants	31.5 Percentage of Participants	30.8 Percentage of Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of previous study part) and week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=27 Participants 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.	Part A: Dupilumab 300 mg SC QW n=27 Participants 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.	Part B: Placebo n=31 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=35 Participants 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.	Part B: Dupilumab 300 mg SC QW n=67 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=56 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change in Health-related QOL as Measured by EoE-IQ at Week 52	-0.954 Score on a Scale Standard Deviation 0.6690	-0.911 Score on a Scale Standard Deviation 0.6344	-1.021 Score on a Scale Standard Deviation 0.7169	-0.858 Score on a Scale Standard Deviation 0.6360	-0.773 Score on a Scale Standard Deviation 0.6217	-0.935 Score on a Scale Standard Deviation 0.6883	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of previous study part) and week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=27 Participants 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.	Part A: Dupilumab 300 mg SC QW n=27 Participants 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.	Part B: Placebo n=32 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=35 Participants 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.	Part B: Dupilumab 300 mg SC QW n=68 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=57 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52	-7.2 Score on a Scale Standard Deviation 6.46	-5.9 Score on a Scale Standard Deviation 6.80	-6.2 Score on a Scale Standard Deviation 6.42	-5.9 Score on a Scale Standard Deviation 6.47	-4.7 Score on a Scale Standard Deviation 5.99	-6.4 Score on a Scale Standard Deviation 6.86	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of previous study part) and week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=27 Participants 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.	Part A: Dupilumab 300 mg SC QW n=27 Participants 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.	Part B: Placebo n=32 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=35 Participants 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.	Part B: Dupilumab 300 mg SC QW n=68 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=57 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52	-4.3 Score on a Scale Standard Deviation 3.78	-3.2 Score on a Scale Standard Deviation 3.50	-4.0 Score on a Scale Standard Deviation 3.54	-3.8 Score on a Scale Standard Deviation 3.62	-3.6 Score on a Scale Standard Deviation 3.45	-4.7 Score on a Scale Standard Deviation 4.03	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of Part C) to week 28

Outcome measures

Outcome measures
Measure	Part A: Placebo n=37 Participants 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.	Part A: Dupilumab 300 mg SC QW n=40 Participants 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.	Part B: Placebo n=37 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=37 Participants 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.	Part B: Dupilumab 300 mg SC QW n=79 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=74 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Percentage of Participants Who Received Rescue Medication During the 28-week Extended Active Treatment Period	8.1 Percentage of Participants	0 Percentage of Participants	2.7 Percentage of Participants	2.7 Percentage of Participants	0 Percentage of Participants	1.4 Percentage of Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of previous study part) and week 52

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Part A: Placebo n=27 Participants 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.	Part A: Dupilumab 300 mg SC QW n=30 Participants 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.	Part B: Placebo n=17 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=24 Participants 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.	Part B: Dupilumab 300 mg SC QW n=60 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=49 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
NES for the Relative Change From Baseline in EoE Diagnostic Panel (EDP) at Week 52	-2.580 Score on a Scale Interval -2.87 to -0.45	-2.670 Score on a Scale Interval -2.83 to -1.09	-2.28 Score on a Scale Interval -2.8 to -0.8	-2.62 Score on a Scale Interval -2.9 to -2.1	-2.64 Score on a Scale Interval -2.9 to 1.2	-2.69 Score on a Scale Interval -2.9 to -0.6	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of previous study part) and week 52

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Part A: Placebo n=27 Participants 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.	Part A: Dupilumab 300 mg SC QW n=30 Participants 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.	Part B: Placebo n=17 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=24 Participants 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.	Part B: Dupilumab 300 mg SC QW n=60 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=49 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
NES for the Relative Change in the Type 2 Inflammation Signature (T2INF) at Week 52	-1.940 Score on a Scale Interval -2.11 to -0.42	-1.970 Score on a Scale Interval -2.07 to -0.95	-1.76 Score on a Scale Interval -2.1 to -1.0	-1.96 Score on a Scale Interval -2.1 to -1.5	-1.95 Score on a Scale Interval -2.1 to 0.3	-1.97 Score on a Scale Interval -2.2 to -0.7	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of Part C) up to week 52

Population: 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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=34 Participants 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.	Part A: Dupilumab 300 mg SC QW n=38 Participants 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.	Part B: Placebo n=36 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=37 Participants 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.	Part B: Dupilumab 300 mg SC QW n=77 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=69 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W 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.	Part B/C: Placebo / Dupilumab 300 mg QW 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW 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.
Concentration of Functional Dupilumab in Serum at Week 52 Week 32	101 milligrams per liter (mg/L) Standard Deviation 44.6	205 milligrams per liter (mg/L) Standard Deviation 76.8	46.0 milligrams per liter (mg/L) Standard Deviation 33.1	124 milligrams per liter (mg/L) Standard Deviation 56.7	74.0 milligrams per liter (mg/L) Standard Deviation 42.0	195 milligrams per liter (mg/L) Standard Deviation 94.6	—	—	—	—	—
Concentration of Functional Dupilumab in Serum at Week 52 Week 52	137 milligrams per liter (mg/L) Standard Deviation 81.6	152 milligrams per liter (mg/L) Standard Deviation 70.2	58.6 milligrams per liter (mg/L) Standard Deviation 36.5	151 milligrams per liter (mg/L) Standard Deviation 96.0	68.9 milligrams per liter (mg/L) Standard Deviation 45.7	176 milligrams per liter (mg/L) Standard Deviation 120	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (of previous study part) up to week 52

Population: 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).

Number of treatment-emergent ADA responses to dupilumab reported.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=39 Participants 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.	Part A: Dupilumab 300 mg SC QW n=42 Participants 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.	Part B: Placebo n=77 Participants 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.	Part B: Dupilumab 300 mg SC Q2W n=77 Participants 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.	Part B: Dupilumab 300 mg SC QW n=76 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=35 Participants 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.	Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=39 Participants 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.	Part B/C: Placebo / Dupilumab 300 mg Q2W n=36 Participants 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.	Part B/C: Placebo / Dupilumab 300 mg QW n=37 Participants 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.	Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W n=77 Participants 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.	Part B/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW n=69 Participants 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.
Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response	0 Events	0 Events	0 Events	2 Events	1 Events	4 Events	1 Events	1 Events	0 Events	5 Events	0 Events

Adverse Events

Part A: Placebo

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Part A: Dupilumab 300 mg QW

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Part B: Placebo

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Part B: Dupilumab 300 mg Q2W

Serious events: 2 serious events

Other events: 57 other events

Deaths: 0 deaths

Part B: Dupilumab 300 mg QW

Serious events: 5 serious events

Other events: 50 other events

Deaths: 0 deaths

Part C: Dupilumab 300 mg Q2W (Placebo in Part B)

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Part C: Dupilumab 300 mg QW (Placebo in Part A or B)

Serious events: 3 serious events

Other events: 44 other events

Deaths: 0 deaths

Part C: Dupilumab 300 mg Q2W (Part B Regimen Continued)

Serious events: 1 serious events

Other events: 47 other events

Deaths: 0 deaths

Part C: Dupilumab 300 mg QW (Part A or B Regimen Continued)

Serious events: 4 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Placebo n=39 participants at risk 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.	Part A: Dupilumab 300 mg QW n=42 participants at risk 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.	Part B: Placebo n=78 participants at risk 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.	Part B: Dupilumab 300 mg Q2W n=81 participants at risk 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.	Part B: Dupilumab 300 mg QW n=80 participants at risk 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.	Part C: Dupilumab 300 mg Q2W (Placebo in Part B) n=37 participants at risk 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.	Part C: Dupilumab 300 mg QW (Placebo in Part A or B) n=74 participants at risk 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.	Part C: Dupilumab 300 mg Q2W (Part B Regimen Continued) n=79 participants at risk 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.	Part C: Dupilumab 300 mg QW (Part A or B Regimen Continued) n=114 participants at risk 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.
Psychiatric disorders Suicidal ideation	2.6% 1/39 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/81 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Psychiatric disorders Depression suicidal	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.2% 1/80 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Psychiatric disorders Mental status changes	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/78 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Gastrointestinal disorders Abdominal pain	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.4% 1/42 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Infections and infestations Campylobacter colitis	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.2% 1/80 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Investigations Blood creatine phosphokinase abnormal	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.2% 1/80 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.2% 1/80 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Reproductive system and breast disorders Uterine polyp	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.4% 1/42 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	2.6% 1/39 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Psychiatric disorders Generalised anxiety disorder	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/79 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Psychiatric disorders Substance use disorder	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/79 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Gastrointestinal disorders Diarrhoea	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.88% 1/114 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Gastrointestinal disorders Rectal tenesmus	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.88% 1/114 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Gastrointestinal disorders Vomiting	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.4% 1/74 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
General disorders Chest pain	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.88% 1/114 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
General disorders Systemic inflammatory response syndrome	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.4% 1/74 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Infections and infestations Cellulitis	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.4% 1/74 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Infections and infestations Enterocolitis infectious	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.88% 1/114 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Infections and infestations Pneumonia aspiration	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.2% 1/80 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Infections and infestations Pneumonia mycoplasmal	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.88% 1/114 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Injury, poisoning and procedural complications Open globe injury	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.7% 1/37 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)

Other adverse events

Other adverse events
Measure	Part A: Placebo n=39 participants at risk 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.	Part A: Dupilumab 300 mg QW n=42 participants at risk 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.	Part B: Placebo n=78 participants at risk 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.	Part B: Dupilumab 300 mg Q2W n=81 participants at risk 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.	Part B: Dupilumab 300 mg QW n=80 participants at risk 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.	Part C: Dupilumab 300 mg Q2W (Placebo in Part B) n=37 participants at risk 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.	Part C: Dupilumab 300 mg QW (Placebo in Part A or B) n=74 participants at risk 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.	Part C: Dupilumab 300 mg Q2W (Part B Regimen Continued) n=79 participants at risk 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.	Part C: Dupilumab 300 mg QW (Part A or B Regimen Continued) n=114 participants at risk 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.
General disorders Injection site erythema	15.4% 6/39 • Number of events 22 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	9.5% 4/42 • Number of events 12 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	11.5% 9/78 • Number of events 42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	22.2% 18/81 • Number of events 93 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	10.0% 8/80 • Number of events 25 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.4% 2/37 • Number of events 32 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	8.1% 6/74 • Number of events 13 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	7.6% 6/79 • Number of events 36 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	8.8% 10/114 • Number of events 21 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
General disorders Injection site reaction	12.8% 5/39 • Number of events 19 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	21.4% 9/42 • Number of events 45 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	20.5% 16/78 • Number of events 69 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	22.2% 18/81 • Number of events 75 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	20.0% 16/80 • Number of events 84 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	8.1% 3/37 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	16.2% 12/74 • Number of events 40 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	17.7% 14/79 • Number of events 50 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	12.3% 14/114 • Number of events 101 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
General disorders Injection site pain	7.7% 3/39 • Number of events 6 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	11.9% 5/42 • Number of events 9 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.1% 4/78 • Number of events 21 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	12.3% 10/81 • Number of events 45 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	8.8% 7/80 • Number of events 39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	10.8% 4/37 • Number of events 34 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	8.1% 6/74 • Number of events 7 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	7.6% 6/79 • Number of events 66 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	7.9% 9/114 • Number of events 45 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
General disorders Injection site oedema	5.1% 2/39 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.8% 2/42 • Number of events 7 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.8% 3/78 • Number of events 7 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.9% 4/81 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.1% 3/74 • Number of events 12 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.8% 3/79 • Number of events 12 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.6% 3/114 • Number of events 8 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
General disorders Injection site pruritus	5.1% 2/39 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.4% 1/42 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.8% 3/78 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.2% 1/81 • Number of events 6 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.0% 4/80 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.7% 1/37 • Number of events 6 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.4% 1/74 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.8% 3/79 • Number of events 8 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
General disorders Injection site bruising	2.6% 1/39 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.4% 1/42 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	7.4% 6/81 • Number of events 7 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.7% 1/37 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.4% 4/74 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/79 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.6% 3/114 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
General disorders Injection site swelling	2.6% 1/39 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	11.9% 5/42 • Number of events 7 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.6% 2/78 • Number of events 10 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	8.6% 7/81 • Number of events 12 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	12.5% 10/80 • Number of events 25 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	10.8% 4/37 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/79 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.5% 4/114 • Number of events 27 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
General disorders Pyrexia	2.6% 1/39 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.8% 2/42 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/78 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.7% 3/81 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	6.2% 5/80 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/79 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.8% 2/114 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
General disorders Fatigue	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.4% 1/42 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.1% 4/78 • Number of events 20 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/81 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	6.2% 5/80 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.7% 1/37 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.4% 1/74 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/79 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.8% 2/114 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
General disorders Injection site urticaria	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.6% 2/78 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	7.4% 6/81 • Number of events 9 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/79 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Infections and infestations Nasopharyngitis	10.3% 4/39 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	11.9% 5/42 • Number of events 6 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.8% 3/78 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.9% 4/81 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/80 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.4% 2/37 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	9.5% 7/74 • Number of events 8 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/79 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.4% 5/114 • Number of events 6 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Infections and infestations Sinusitis	5.1% 2/39 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.4% 1/42 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.0% 4/80 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.7% 2/74 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/79 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.88% 1/114 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Infections and infestations COVID-19	2.6% 1/39 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	6.2% 5/81 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.0% 4/80 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.7% 1/37 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	9.5% 7/74 • Number of events 7 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	10.1% 8/79 • Number of events 8 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	8.8% 10/114 • Number of events 10 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Infections and infestations Upper respiratory tract infection	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	9.5% 4/42 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.6% 2/78 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/81 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.8% 3/80 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.7% 2/74 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.3% 6/114 • Number of events 7 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Skin and subcutaneous tissue disorders Dermatitis atopic	10.3% 4/39 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/78 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.4% 1/74 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/79 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.8% 2/114 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Skin and subcutaneous tissue disorders Rash	10.3% 4/39 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.9% 4/81 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.8% 3/80 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.7% 1/37 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/79 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	6.1% 7/114 • Number of events 9 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Gastrointestinal disorders Nausea	7.7% 3/39 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.4% 1/42 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	9.0% 7/78 • Number of events 7 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.9% 4/81 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	6.2% 5/80 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.4% 2/37 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.4% 1/74 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/79 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.5% 4/114 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Gastrointestinal disorders Abdominal pain	5.1% 2/39 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.4% 1/42 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.1% 4/78 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/81 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.0% 4/80 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/79 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.5% 4/114 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Gastrointestinal disorders Diarrhoea	5.1% 2/39 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.8% 2/42 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	10.3% 8/78 • Number of events 12 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.7% 3/81 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.2% 1/80 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.4% 2/37 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.7% 2/74 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/79 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Gastrointestinal disorders Dysphagia	5.1% 2/39 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.2% 1/81 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/80 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.7% 1/37 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.4% 1/74 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.1% 4/79 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.5% 4/114 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Gastrointestinal disorders Vomiting	2.6% 1/39 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.8% 2/42 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.1% 4/78 • Number of events 6 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.7% 3/81 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.8% 3/80 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.7% 1/37 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.1% 3/74 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/79 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.5% 4/114 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Gastrointestinal disorders Dyspepsia	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.1% 4/78 • Number of events 9 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/81 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.4% 4/74 • Number of events 6 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/79 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.5% 4/114 • Number of events 6 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Nervous system disorders Headache	10.3% 4/39 • Number of events 11 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.8% 2/42 • Number of events 7 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	11.5% 9/78 • Number of events 28 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	6.2% 5/81 • Number of events 10 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	8.8% 7/80 • Number of events 8 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.4% 2/37 • Number of events 6 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.4% 4/74 • Number of events 9 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.1% 4/79 • Number of events 6 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.4% 5/114 • Number of events 8 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.1% 2/39 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	7.7% 6/78 • Number of events 7 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	6.2% 5/81 • Number of events 6 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.0% 4/80 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/79 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.88% 1/114 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	5.1% 2/39 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.4% 1/42 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.6% 2/78 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.2% 1/81 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/80 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.1% 3/74 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.88% 1/114 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	7.1% 3/42 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.88% 1/114 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Investigations Blood creatine phosphokinase increased	5.1% 2/39 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/78 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.2% 1/81 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.8% 3/80 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	10.8% 4/37 • Number of events 6 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	4.1% 3/74 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/79 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.8% 2/114 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Vascular disorders Hypertension	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.4% 1/42 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/78 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.2% 1/81 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.0% 4/80 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/79 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.8% 2/114 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Skin and subcutaneous tissue disorders Acne	2.6% 1/39 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.8% 3/78 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/81 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.4% 2/37 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.4% 4/74 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/79 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.8% 2/114 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Gastrointestinal disorders Eosinophilic oesophagitis	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	10.8% 4/37 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/79 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/114 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Immune system disorders Food allergy	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.2% 1/81 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/80 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.4% 2/37 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/74 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/79 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.8% 2/114 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/78 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/81 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/80 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/37 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.4% 1/74 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.1% 4/79 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.8% 2/114 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)
Psychiatric disorders Anxiety	0.00% 0/39 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	0.00% 0/42 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/78 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.5% 2/81 • Number of events 2 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.8% 3/80 • Number of events 3 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	2.7% 1/37 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	5.4% 4/74 • Number of events 4 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	1.3% 1/79 • Number of events 1 • From day of first dose up to 12 weeks after end of treatment visit (week 52)	3.5% 4/114 • Number of events 5 • From day of first dose up to 12 weeks after end of treatment visit (week 52)

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals, Inc.

Phone: 844-734-6643

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER