NMF-CsA-Dupi Trial

Erasmus University

Status: Enrolling

Conditions: Dermatitis, Atopic

Treatments: Drug: Topical corticosteroids; Drug: Systemic cyclosporine; Drug: Systemic dupilumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04878770

MEC-2019-0568

2019-003247-30 (EudraCT Number)

Details and patient eligibility

About

The goal of this study is to investigate whether stratification of children with atopic dermatitis on the NMF biomarkers results in an improvement of effectiveness and efficiency in the use of systemic treatment (ciclosporin and dupilumab) in moderate-to-severe atopic dermatitis.

Enrollment: 318 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children and adolescents, aged 2-18 years, with moderate-to-severe atopic dermatitis (diagnosed according to the UK working party criteria)
• Patient and parents/guardians able to participate in the study and willing to give written informed consent
• EASI (Eczema Area Severity Index) ≥ 6 at screening and baseline (corresponding with moderate-to-severe disease)
• IGA (Investigator Global Assessment) ≥ 3 at screening and baseline (corresponding with moderate-to-severe disease)

Exclusion criteria

• Children under the age of 2 years and patients older than 18 years
• Contraindication for ciclosporin
• Contraindication for dupilumab
• Patient (or one of the parents/guardians) not willing to be randomized
• Children with a history of any known primary immunodeficiency disorder
• Children with a history of cancer
• EASI < 6 at screening or baseline
• IGA < 3 at screening or baseline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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318 participants in 3 patient groups

Topical corticosteroids (control)

Active Comparator group

Description:

This group will receive topical corticosteroids.

Treatment:

Drug: Topical corticosteroids

Systemic cyclosporine

Active Comparator group

Description:

This group will receive topical corticosteroids and systemic cyclosporin.

Treatment:

Drug: Systemic cyclosporine

Drug: Topical corticosteroids

Systemic dupilumab

Active Comparator group

Description:

his group will receive topical corticosteroids and systemic dupilumab.

Treatment:

Drug: Systemic dupilumab

Drug: Topical corticosteroids