The efficacy and safety of DUPIXENT were evaluated in patients aged 1-11 years in a multipart, phase 3 trial for up to 52 weeks1,2

Study Design

Part A 24-Week Placebo-Controlled Treatment Period
  • EoE KIDS Part A: A 16-week, double-blind, placebo-controlled trial. Subjects were randomized to receive either DUPIXENT or placebo at dosing regimens based on body weight: ≥15 to <30 kg (200 mg Q2W) and ≥30 to <60 kg (300 mg Q2W)1,2,a,b
  • EoE KIDS Part B: A 36-week active treatment extension study, for a total of 52 weeks of treatment in subjects who were treated with DUPIXENT or placebo completing Part A. Subjects received DUPIXENT at dosing regimens based on body weight: ≥15 to <30 kg (200 mg Q2W), ≥30 to <60 kg (300 mg Q2W), and ≥60 kg (300 mg QW)1
  • All enrolled subjects were required to have uncontrolled EoE as defined by ≥15 intraepithelial EOS/HPF despite 8-week course of a high-dose PPI and history of EoE signs and symptoms1,2

aThe 300 mg Q2W dosing regimen is lower than the recommended dosage of DUPIXENT in subjects ≥40 kg.1

bA lower exposure DUPIXENT arm was studied in Part A (n=26) and Part B (n=36) but is not approved for the treatment of EoE.


DUPIXENT (n=32) 7.4 (2.8)
Placebo (n=29) 8.1 (2.4)
DUPIXENT (n=32) 25 (78.1)
Placebo (n=29) 21 (72.4)
DUPIXENT (n=32) 17 (53.1)
Placebo (n=29) 8 (27.6)
DUPIXENT (n=32) 27 (84.4)
Placebo (n=29) 24 (82.8)
DUPIXENT (n=32) 27 (84.4)
Placebo (n=29) 22 (75.9)
DUPIXENT (n=32) 97.7 (48.2)
Placebo (n=29) 82.2 (36.2)
DUPIXENT (n=32) 6.9 (2.6)
Placebo (n=29) 7.3 (2.6)
DUPIXENT (n=32) 50.8 (27.6)
Placebo (n=29) 51.4 (34.1)
DUPIXENT (n=32) 0.43 (0.39)
Placebo (n=29) 0.49 (0.36)
  • Patients using PPIs during screening were either to continue throughout the entire study or stop prior to baseline2
  • Unless used as rescue medications, systemic and/or swallowed TCS were prohibited during the treatment period2

EOS/HPF, eosinophils per high-power field; EREFS, endoscopic reference score; PPI, proton pump inhibitor; PESQ-C, Pediatric EoE Signs/Symptoms Questionnaire-Caregiver; QW, once weekly; Q2W, once every 2 weeks; TCS, topical corticosteroids.