Dupilumab-PEdiatric skin barrier function and LIpidomics STudy in patients with Atopic Dermatitis

Phase 1

• Conditions: Atopic dermatitis; MedDRA version: 20.0Level: PTClassification code 10012438Term: Dermatitis atopicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-001518-40-GB
• Lead Sponsor: Sanofi Aventis Recherche & Developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-14
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 48

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 ISS.
- 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 48
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified