Status:
COMPLETED
Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Dermatitis Atopic
Eligibility:
All Genders
6-11 years
Phase:
PHASE4
Brief Summary
Primary Objective: \- Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in predefined lesional skin in pediatric participants wi...
Detailed Description
Total study duration including screening and follow-up was 32 weeks.
Eligibility Criteria
Inclusion
- 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 participants:
- Male or female pediatric participants.
- Participants with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening.
- Investigator Global Assessment (IGA) score of \>=3 (for US participants) or IGA \>=4 (for EU participants) at screening (on the 0-4 scale) depending on approved label indication in the country.
- Participants with moderate to severe AD those were eligible to be treated with dupilumab according to product label.
- Participants with AD must have had 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 Individual Signs Score.
- Participants should have had a non-lesional (normal looking) skin area 4 centimeter (cm) from the edge of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional area, it was 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 participant by study site.
- 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 (i.e., skin atrophy, ichthyosis, tinea infection, contact dermatitis).
- Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that was 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.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04718870
Start Date
February 19 2021
End Date
November 30 2022
Last Update
September 15 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational Site Number :8400002
Los Angeles, California, United States, 90027
2
Investigational Site Number :8400001
Denver, Colorado, United States, 80206
3
Investigational Site Number :8260001
Sheffield, United Kingdom, S10 2TH