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In the treatment of infants to preschoolers (6 months to 5 years of age) with uncontrolled moderate-to-severe atopic dermatitis

Significant itch reduction at Week 16

Reduction in itch after first dose (as measured at Week 3)

AD-1539 6 MONTHS TO 5 YEARS

≥4-POINT REDUCTION IN WORST
SCRATCH/ITCH NRS AT WEEK 16
(secondary endpoint)1-3,a,b

Definitive conclusions cannot be made for time points earlier than Week 16 as those data were not multiplicity controlled and P value was nominal.

aFull Analysis Set includes all subjects randomized.1

bIn the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.1

Worst Scratch/Itch NRS assesses the average itch intensity over the previous 24 hours4

It is a patient-reported measure that uses a 0- to 10-point scale, with which caregivers of infants to preschoolers aged 6 months to 5 years were asked:

“How would you rate your child’s scratching/itching at its worst in the past 24 hours?”

0 - NONE

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5

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10 - THE WORST
IMAGINABLE

A reduction of at least 4 points in Worst Scratch/Itch from baseline is a clinically meaningful change.2