Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-19

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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Total study duration including screening and follow-up was 32 weeks.

Conditions

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Dermatitis Atopic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atopic Dermatitis Participants

Pediatric participants with moderate-to-severe atopic dermatitis (AD) and with baseline body weight more than or equal to (\>=) 15 kilograms (kg) and less than (\<) 30 kg received a subcutaneous (SC) loading dose of dupilumab 600 milligrams (mg) (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection every 4 weeks (Q4W), from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection every 2 weeks (Q2W), from Week 2 to Week 14.

Group Type EXPERIMENTAL

Dupilumab SAR231893

Intervention Type DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)

Healthy Volunteers

Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to selected AD participants, received no treatment, but were monitored in a similar way as AD participants.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dupilumab SAR231893

Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)

Intervention Type DRUG

Other Intervention Names

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REGN668

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes