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 个研究点目标入组 48 人开始时间: 2020年8月14日最近更新: 2020年10月13日

适应症

试验速览

暂无简介。

•- 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

•- 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.

发起方

Sanofi Aventis Recherche & Developpement