Status:
UNKNOWN
NMF-CsA-Dupi Trial
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
2-18 years
Phase:
NA
Brief 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 systemi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT04878770
Start Date
August 16 2021
End Date
January 1 2025
Last Update
August 18 2021
Active Locations (1)
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1
Erasmus MC - Sophia Children's Hospital
Rotterdam, South Holland, Netherlands