NMF-CsA-Dupi Trial

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Cyclosporine; Cyclosporins

Criteria

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