Atopic dermatitis MedDRA version: 20.0 Level: PT Classification code 10012438 Term: Dermatitis atopic System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Dupilumab
Product Code: SAR231893
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Dupilumab
Current Sponsor code: SAR231893
Other descriptive name:
Sponsors
Sanofi Aventis Recherche & Developpement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be between =6 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 Objective: 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 ;Primary end point(s): Percent change from baseline in TEWL after 5 STS assessed on lesional skin in AD patients ; Percent change from baseline in TEWL after 5 STS assessed on lesional skin in AD patients. ;Timepoint(s) of evaluation of this end point: Baseline to week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 : Baseline to week 16 12, 13, 14, 15, 16, 17, 18, 19, 20 : Baseline to week 28 ;Secondary end point(s): 1 - Percent change from baseline in TEWL after 20 STS assessed on lesional skin in AD patients. Absolute change from baseline in TEWL after 20 STS assessed on lesional skin in AD patients 2 - Percent change from baseline in TEWL after 20 STS assessed on non-lesional skin in AD patients. Absolute change from baseline in TEWL after 20 STS assessed on non-lesional skin in AD patients. 3 - Percent change from baseline in TEWL after 20 STS assessed on normal skin in healthy volunteers Absolute change from baseline in TEWL after 20 STS assessed on normal skin in healthy volunteers 4 - Percent change from baseline in TEWL after 15 STS assessed on lesional skin in AD patients. Absolute change from baseline in TEWL after 15 STS assessed on lesional skin in AD patients. 5 - Percent change from baseline in TEWL after 15 STS assessed on non-lesional skin in healthy volunteers Absolute change from baseline in TEWL after 15 STS assessed on non-lesional skin in healthy volunteers 6 - Percent change from baseline in TEWL after 15 STS assessed on normal skin in healthy volunteers Absolute change from baseline in TEWL after 15 STS assessed on normal skin in healthy volunteers 7 - Percent change from baseline in TEWL after 10 STS assessed on lesional skin in AD patients. Absolute change from baseline in TEWL after 10 STS assessed on lesional skin in AD patients 8 - Percent change from baseline in TEWL after 10 STS assessed on non-lesional skin in AD patients. Absolute change from baseline in TEWL after 10 STS assessed on non- lesional skin in AD patients 9 - Percent change from baseline in TEWL after 10 STS assessed on normal skin in healthy volunteer Absolute change from baseline in TEWL after 10 STS assessed on normal skin in healthy volunteer 10 - Percent change from baseline | — |
Countries
United Kingdom, United States
Contacts
Public ContactMedical Information
Sanofi-aventis Recherche & Développement
Outcome results
None listed