Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis
Condition: Dermatitis Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: Dupilumab SAR231893
Intervention description: Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Primary Objective:

      - Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed
      after skin tape stripping (STS) in predefined lesional skin in pediatric participants with
      moderate to severe atopic dermatitis (AD) treated with dupilumab.

      Secondary Objectives:

        -  Evaluate changes in skin barrier function with TEWL assessed after STS in predefined
           lesional and non-lesional skin in pediatric participants with moderate to severe AD
           treated with dupilumab in reference to normal skin of healthy volunteers.

        -  Evaluate time course of change in skin barrier function with TEWL assessed before and
           after STS in predefined lesional and non-lesional skin in pediatric participants with
           moderate to severe AD during dupilumab treatment phase and follow-up period in reference
           to normal skin of healthy volunteers.
    

Eligibility criteria:

        Inclusion criteria :

          -  Participant must be between >=6 to <12 years of age (inclusive), at the time of
             signing the informed consent

          -  15 kg <= body weight <60 kg.

        Atopic dermatitis participants:

          -  Male or female pediatric participants.

          -  Participants with AD diagnosis according to Hanifin and Rajka criteria at least 1 year
             before screening.

          -  Investigator Global Assessment (IGA) score of >=3 (for US participants) or IGA >=4
             (for EU participants) at screening (on the 0-4 scale) depending on approved label
             indication in the country.

          -  Participants with moderate to severe AD those were eligible to be treated with
             dupilumab according to product label.

          -  Participants with AD must have had active lesions on the upper limbs or lower limbs
             (including trunk, if needed), with severity for lesion erythema or edema/papulation
             >=2 at screening on the 0-3 scale of the Individual Signs Score.

          -  Participants should have had a non-lesional (normal looking) skin area 4 centimeter
             (cm) from the edge of the lesional area. If unable to identify non-lesional skin 4 cm
             from the lesional area, it was acceptable to identify normal looking skin as close to
             the lesion as possible.

        Healthy volunteers:

        - Age and gender matched (match on age ±2 years) to a selected AD participant by study
        site.

        Exclusion criteria:

          -  Previous treatment with dupilumab within 6 months prior to screening.

          -  Skin conditions other than AD that can confound assessments in the area of TEWL
             assessments in the opinion of the Investigator (i.e., skin atrophy, ichthyosis, tinea
             infection, contact dermatitis).

          -  Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment
             area leaving insufficient skin that was 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 the
             individual's risk for study participation. Examples include -but are not limited to-
             individuals with a history of active cases of herpes keratitis; Sjogren's syndrome,
             keratoconjunctivitis sicca, or individuals with ocular conditions that require the use
             of ocular corticosteroids or cyclosporine.

          -  Healthy volunteers with a personal history of an atopic condition.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.