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 & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be between 12 to 65 years of age (inclusive), at the time of signing the informed consent. Atopic dermatitis patients: - Male or female patients. - Patients with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening. - IGA score of =3 at screening (on the 0-4 scale). - Patients with moderate to severe atopic dermatitis that are eligible to be treated with dupilumab according to product monograph - Patients with AD must have active lesions on the upper limbs or lower limbs, 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 to a selected AD patient. Adolescents aged 12 to 17 years will be matched by post puberty status, and adults aged 18 to 65 years will be matched by age as close as possible within 10 years of age.. Are the trial subjects under 18? yes Number of subjects for this age range: 24 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=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, Netherton syndrome, severe photo damage). - Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that is adequate for TEWL assessments. - 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 dry eye syndrome that require daily use of supplemental lubrication; 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 pre-defined lesional skin in 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 pre-defined lesional and non-lesional skin in patients with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers. - Evaluate time course of skin barrier function with TEWL assessed before and after STS in pre-defined lesional and non-lesional skin in patients with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers ;Primary end point(s): Percent change in TEWL after 5 STS 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 |
|---|---|
| Secondary end point(s): 1 - Percent change in TEWL after 20 STS on lesional skin in AD patients Absolute change in TEWL after 20 STS on lesional skin in AD patients 2 - Percent change in TEWL after 20 STS on non-lesional skin in AD patients Absolute change in TEWL after 20 STS on non-lesional skin in AD patients 3 - Percent change in TEWL after 20 STS on normal skin in healthy volunteers Absolute change in TEWL after 20 STS on normal skin in healthy volunteers 4 - Percent change in TEWL after 15 STS on lesional skin in AD patients Absolute change in TEWL after 15 STS on lesional skin in AD patients 5 - Percent change in TEWL after 15 STS on non-lesional skin in AD patients Absolute change in TEWL after 15 STS on non-lesional skin in AD patients 6 - Percent change in TEWL after 15 STS on normal skin in healthy volunteers Absolute change in TEWL after 15 STS on normal skin in healthy volunteers 7 - Percent change in TEWL after 10 STS on lesional skin in AD patients Absolute change in TEWL after 10 STS on lesional skin in AD patients 8 - Percent change in TEWL after 10 STS on non-lesional skin in AD patients Absolute change in TEWL after 10 STS on non-lesional skin in AD patients 9 - Percent change in TEWL after 10 STS on normal skin in healthy volunteers Absolute change in TEWL after 10 STS on normal skin in healthy volunteers 10 - Absolute change in TEWL after 5 STS on lesional skin in AD patients 11 - Percent change in TEWL after 5 STS on non-lesional skin in AD patients Absolute change in TEWL after 5 STS on non-lesional skin in AD patients 12 - Percent change in TEWL after 5 STS on normal skin in healthy volunteers Absolute change in TEWL after 5 STS on normal skin in healthy volunteers 13 - Percent change in TEWL before STS on lesional skin in AD patients over time Absolute change in TEWL before STS on lesional skin in AD patients over time 14 - Percent change in TEWL before STS on non-lesional skin in AD patients over time Absolute change in TEWL | — |
Countries
Canada, United States
Contacts
Public ContactLantier
Lorraine
Outcome results
None listed