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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Dermatitis Atopic

Treatments: Drug: Dupilumab SAR231893

Study type: Interventional

Funder types: Industry

Identifiers

NCT04718870

U1111-1255-4378 (Other Identifier)

LPS16764

2020-001518-40 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 41 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Atopic Dermatitis Participants

Experimental group

Description:

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.

Treatment:

Drug: Dupilumab SAR231893

Healthy Volunteers

No Intervention group

Description:

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.