NMF-CsA-Dupi Trial

Sponsor
Erasmus Medical Center
Study ID
NCT04878770
Status
Unknown

Conditions

  • Dermatitis, Atopic

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Topical corticosteroids — DRUG
    Topical corticosteroids (TCS) are registered for patients of all ages, and are together with emollients, the pillars in the basic treatment of atopic dermatitis. In this study, patients in both the intervention groups and control group are treated with daily emollients and a TCS of moderate to high potency if needed. Rescue medication with TCS of higher potency may be prescribed if basic therapy is inadequate in controlling AD symptoms.
  • Systemic cyclosporine — DRUG
    Systemic cyclosporine A (CsA) is an immunosuppressive therapy and is a registered treatment for AD in adults. According to national guidelines, CsA is the first choice for systemic treatment in children with moderate-to-severe AD. For CsA a starting dose of 4-5mg/kg/day is administered orally and then tapered down to 2-3mg/kg/day depending on clinical effect. Two doses will be taken at two fixed times per day. Treatment with systemic CsA will be continued for a total of 6 months.
  • Systemic dupilumab — DRUG
    Dupilumab (DUPIXENT) is indicated for the treatment of children of 6 years and older with moderate-to-sever atopic dermatitis whos disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. rm: Active Comparator: Systemic dupilumab Dupilumab (DUPIXENT) is administered as a solution by subdermal injection according to national guidelines, based on age and body weight.

Study Details

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.

Key Dates

Start date
Aug 16, 2021
Status verified
Aug 2021
Primary completion
Jan 1, 2024
Completion
Jan 1, 2025

Study Design

Enrollment
318 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Topical corticosteroids (control)
    This group will receive topical corticosteroids.
  • Active Comparator: Systemic cyclosporine
    This group will receive topical corticosteroids and systemic cyclosporin.
  • Active Comparator: Systemic dupilumab
    his group will receive topical corticosteroids and systemic dupilumab.

Primary Outcome Measure

EASI [ Time Frame: t = 0, 1 month, 2 months, 3 months and 6 months ]

Central Contacts

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