Open-label exploratory study to evaluate the effect of dupilumab on skin barrier function in pediatric patients with moderate to severe atopic dermatitis - PELISTAD

Sanofi Aventis Recherche & Developpement0 sites48 target enrollmentAugust 14, 2020

Overview

No summary available.

Registry

who.int

Start Date

August 14, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Sanofi Aventis Recherche & Developpement

•\- 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:

•\- 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.