Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis

NCT04718870 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: LPS167642020-001518-40U1111-1255-4378
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 3

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.

Conditions

Dermatitis Atopic

Outcome Measures

Primary Outcomes (1)

• 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

  TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize skin barrier function (SBF). TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. Lesional skin (LS) areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on the first spot. Percent Change from Baseline at Week 16 in TEWL after 5 STS on LS (first spot) in AD participants were reported in this outcome measure (OM).

  Baseline, Week 16

Secondary Outcomes (40)

• Percent Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16

  Baseline, Week 16

• Absolute Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16

  Baseline, Week 16

• Percent Change From Baseline in TEWL After 20 STS on Non-lesional Skin (Non-LS) in AD Participants at Week 16

  Baseline, Week 16

• Absolute Change From Baseline in TEWL After 20 STS on Non-lesional Skin in AD Participants at Week 16

  Baseline, Week 16

• Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16

  Baseline, Week 16

Study Arms (2)

Atopic Dermatitis Participants

EXPERIMENTAL

Pediatric participants with moderate-to-severe atopic dermatitis (AD) and with baseline body weight more than or equal to (\>=) 15 kilograms (kg) and less than (\<) 30 kg received a subcutaneous (SC) loading dose of dupilumab 600 milligrams (mg) (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection every 4 weeks (Q4W), from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection every 2 weeks (Q2W), from Week 2 to Week 14.

Drug: Dupilumab SAR231893

Healthy Volunteers

NO INTERVENTION

Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to selected AD participants, received no treatment, but were monitored in a similar way as AD participants.

Interventions

Dupilumab SAR231893 DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)

Also known as: REGN668

Atopic Dermatitis Participants

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participant must be between \>=6 to \<12 years of age (inclusive), at the time of signing the informed consent
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (3)

Investigational Site Number :8400002

Los Angeles, California, 90027, United States

Location

Investigational Site Number :8400001

Denver, Colorado, 80206, United States

Location

Investigational Site Number :8260001

Sheffield, S10 2TH, United Kingdom

Location

Related Links

• LPS16764 Plain Language Results Summary

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: February 19, 2021
• Primary Completion: September 7, 2022
• Study Completion: November 30, 2022
• Last Updated: September 15, 2025
• Results First Posted: October 17, 2023

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); US (2)