Dupilumab step-down strategy to maintain remission in adult and adolescents patients with atopic dermatitis: a non-inferiority randomized trial
A legfontosabb adatok
- Fázis
- 4. fázis
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A vizsgálat adatai
- Ki végzi
- Centre Hospitalier Universitaire De Nantes
- Azonosító
- EU 2022-501179-23-00
- A regiszteradat frissítve
- 2025. július 11.
- Eredeti leírás
demonstrate the non-inferiority of a step down dosage strategy (injection spacing) of dupilumab as compared with maintenance of initial treatment, on long-term control of the disease severity at one year in adolescents and adults patients with controlled AD.A teljes eredeti leírásKevesebb
demonstrate the non-inferiority of a step down dosage strategy (injection spacing) of dupilumab as compared with maintenance of initial treatment, on long-term control of the disease severity at one year in adolescents and adults patients with controlled AD.
Bevonási feltételek: Age ≥ 12 years; Moderate to severe AD treated with dupilumab every 2 weeks; Written informed consent (patient and/or person who has parental authority); Dupilumab treatment for at least one year; Controlled AD (ADCT<7 and IGA ≤ 2) and assessed as controlled by the investigator since at least 6 months without tapering dosage of dupilumab; Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months and less than 60 g/month.
Kizáró feltételek: Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months and less than 60 mg/month; Non controlled AD: ADCT ≥ 7 or IGA ≥ 3; Female patient must not be pregnant, breastfeeding or considering becoming pregnant; Patient under judicial protection; Adults under guardianship or trusteeship.