NMF-CsA-Dupi Trial

Last updated: August 17, 2021
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy

Dermatitis, Atopic

Eczema (Atopic Dermatitis - Pediatric)

Treatment

N/A

Clinical Study ID

NCT04878770
MEC-2019-0568
2019-003247-30
  • Ages 2-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 givewritten informed consent
  • EASI (Eczema Area Severity Index) ≥ 6 at screening and baseline (corresponding withmoderate-to-severe disease)
  • IGA (Investigator Global Assessment) ≥ 3 at screening and baseline (corresponding withmoderate-to-severe disease)

Exclusion

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

Study Design

Total Participants: 318
Study Start date:
August 16, 2021
Estimated Completion Date:
January 01, 2025

Connect with a study center

  • Erasmus MC - Sophia Children's Hospital

    Rotterdam, Zuid-Holland
    Netherlands

    Active - Recruiting

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