NMF-CsA-Dupi Trial

NAUnknownINTERVENTIONAL
Enrollment

318

Participants

Timeline

Start Date

August 16, 2021

Primary Completion Date

January 1, 2024

Study Completion Date

January 1, 2025

Conditions
Dermatitis, Atopic
Interventions
DRUG

Topical corticosteroids

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.

DRUG

Systemic cyclosporine

"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."

DRUG

Systemic dupilumab

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.

Trial Locations (1)

Unknown

RECRUITING

Erasmus MC - Sophia Children's Hospital, Rotterdam

Sponsors
All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

lead

Erasmus Medical Center

OTHER

NCT04878770 - NMF-CsA-Dupi Trial | Biotech Hunter | Biotech Hunter