A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis

Inclusion Criteria:

Age

• For new participants: ≥6 to <12 years of age (inclusive), at the time of signing theinformed consent.

• For former PELISTAD participants: ≥6 to <15 years of age at the time of signing theinformed consent.

Type of participant and disease characteristics

• With AD diagnosis according to Hanifin and Rajka criteria at least 1 year beforescreening.

• Applicable to new participants only: Validated Investigator Global Assessment for AD (vIGA AD™) score of ≥3 (for US and Canada participants) or ≥4 (for UK participants)at screening (on the 0 to 4 scale) depending on the approved vIGA-AD™ labelindication in the country.

• Applicable to new participants only: Have active lesions on the upper limbs or lowerlimbs (including trunk, if needed), with severity for lesion erythema oredema/papulation ≥2 at screening on the 0 to 3 scale of the ISS.

• Applicable to all participants: Should have a non-lesional (normal looking) skinarea 4 cm from the edge of the lesional area. If unable to identify non-lesionalskin 4 cm from the lesional area, it is acceptable to identify normal looking skinas close to the lesion as possible.

• Willing to refrain from applying any topical medications on the target assessmentareas (including lesional and non-lesional) throughout the study until EoS unlessnecessary to alleviate intolerable symptoms.

• Willing and able to comply with all clinic visits and study-related procedures.Weight

• Body weight ≥15 kg at screening.

Exclusion Criteria:

Medical conditions

• Skin conditions other than AD that can confound assessments in the area of TEWLassessments in the opinion of the Investigator (ie, skin atrophy, ichthyosis, tineainfection, contact dermatitis).

• Cracked, crusted, oozing, or bleeding AD lesions in the designated lesionalassessment area leaving insufficient skin that is adequate for TEWL assessments.

• Hypersensitivity to the active substance or to any of the excipients of dupilumab.

• Ocular disorder that in the opinion of the Investigator could adversely affect theindividual's risk for study participation.

• Severe concomitant illness(es) that, in the Investigator's judgment, would adverselyaffect the participant's participation in the study.

• History of hypersensitivity reaction to skin tape or adhesives used in tape stripdiscs.

Prior/concomitant therapy

• Treatment with any investigational medication other than dupilumab within 16 weeksor within 5 half-lives (if known) prior to Day 1, whichever is longer.

• Systemic AD treatment, cyclosporine A (CsA), systemic corticosteroids, azathioprine (AZA), methotrexate (MTX), mycophenolate mofetil (MMF), or Janus kinase (JAK)inhibitors or phototherapy within 4 weeks of baseline.

• Topical AD treatment within 1 week of baseline. Face and neck may be treated withtopical steroids during the washout period if approved by the Investigator.

• Participants who received a live vaccine within 4 weeks of baseline.Prior/concurrent clinical study experience

• Current participation in another investigational or interventional clinical study.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.