Clinical trial NCT04718870: Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis
Official title: Open-label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier Function in Pediatric Patients With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2021-01-22
Enrollment: 41
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with moderate to severe atopic dermatitis (AD) treated with dupilumab.

Secondary Objectives:

* Evaluate changes in skin barrier function with TEWL assessed after STS in predefined lesional and non-lesional skin in pediatric participants 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 participants with moderate to severe AD during dupilumab treatment phase and follow-up period in reference to normal skin of healthy volunteers.

Detailed description: Total study duration including screening and follow-up was 32 weeks.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Participants at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Percent Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in TEWL After 20 STS on Non-lesional Skin (Non-LS) in AD Participants at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in TEWL After 20 STS on Non-lesional Skin in AD Participants at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
timeFrame: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
measure: Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
timeFrame: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
measure: Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
timeFrame: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
measure: Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
timeFrame: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
measure: Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
timeFrame: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
measure: Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
timeFrame: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
measure: Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197
timeFrame: Baseline, Days 57, 113 and 197
measure: Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197
timeFrame: Baseline, Days 57, 113 and 197
measure: Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197
timeFrame: Baseline, Days 57, 113 and 197
measure: Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197
timeFrame: Baseline, Days 57, 113 and 197
measure: Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197
timeFrame: Baseline, Days 57, 113 and 197
measure: Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197
timeFrame: Baseline, Days 57, 113 and 197
measure: Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197
timeFrame: Baseline, Days 57, 113 and 197
measure: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197
timeFrame: Baseline, Days 57, 113 and 197
measure: Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197
timeFrame: Baseline, Days 57, 113 and 197
measure: Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197
timeFrame: Baseline, Days 57, 113 and 197
measure: Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197
timeFrame: Baseline, Days 57, 113 and 197
measure: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197
timeFrame: Baseline, Days 57, 113 and 197
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Investigational Site Number :8400002
state: California
city: Denver
country: United States
facility: Investigational Site Number :8400001
state: Colorado
city: Sheffield
country: United Kingdom
facility: Investigational Site Number :8260001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: