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

• Status: Recruiting
• Trial end date: 2022-09-12
• Target enrollment: 0
• Participant gender: All

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 patients 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 patients 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 patients with moderate to severe AD during dupilumab treatment phase and follow-up period in reference to normal skin of healthy volunteers

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals

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 patients:

• Male or female pediatric patients.

• Patients with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening.

• Investigator Global Assessment (IGA) score of ≥3 (for US patients) or IGA ≥4 (for EU patients) at screening (on the 0-4 scale) depending on approved label indication in the country.

• Patients with moderate to severe AD those are eligible to be treated with dupilumab according to product label.

• Patients with AD must have 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 a non-lesional (normal looking) skin area 4 cm from the edge of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional area, it is 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 patient 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 (ie, skin atrophy, ichthyosis, tinea infection, contact dermatitis).

• Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment 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 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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.