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PROTYPE2
Ensayo de Sanofi en Dermatitis atopica.
Más ensayos de: Dermatitis atópica.
- Fase
- no aplica
- Estado
- En marcha, sin reclutar
- Participantes
- 572
- Centros
- 55
- Fin del objetivo primario
- mar 2028
Título oficial en el registro (en inglés): Real-world Effectiveness Study of Long-term Treatment With Dupilumab in Participants ≥6 Years With Atopic Dermatitis
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en mar 2023.
Qué mide
Number of patients who maintain Eczema Area and Severity Index (EASI) ≤ 7 OR peak pruritus Numerical Rating Scale (NRS) ≤ 4 OR Dermatology Life Quality Index (DLQI) ≤ 5 (From Month 6 to Month 12) (del registro, en inglés)
Qué se prueba
Estudio que busca caracterizar a los pacientes con dermatitis atópica en Alemania que reciben dupilumab en condiciones cotidianas.
Lo que dice el documentoThe aim of this NIS is the characterization of the AD patient population in Germany, receiving dupilumab under everyday conditions in terms of their medical history, socio-demographic and disease-related characteristics, associated atopic comorbidities and type 2 inflammation diseases, concomitant therapy as well as previous systemic and ongoing AD treatments.
Traducción automática (claude-haiku-5-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a Prospective, non-interventional (NIS) observational study in patients (≥6 years) with atopic dermatitis (AD) receiving dupilumab for the prospective evaluation of signs and symptoms, quality of life and disease control. The aim of this NIS is the characterization of the AD patient population in Germany, receiving dupilumab under everyday conditions in terms of their medical history, socio-demographic and disease-related characteristics, associated atopic comorbidities and type 2 inflammation diseases, concomitant therapy as well as previous systemic and ongoing AD treatments. In addition to the therapeutic response rate at Month 6, the long-term efficacy of dupilumab at Month 12 and Month 24 will be assessed by additional outcomes by measuring disease control in AD patients using questionnaires such as Atopic Dermatitis Control Tool (ADCT) and Recap of Atopic Eczema (RECAP). In addition, this NIS aims to assess the dosing pattern of dupilumab for AD, including variations in dosing regimen, reason for dupilumab treatment initiation or discontinuation, or change in therapy and concomitant therapies and duration of treatment. In addition, the effect of dupilumab in adult and pediatric AD patients with associated atopic comorbidities or type-2 inflammation diseases are observed, which corresponds to the clinical care situation. Finally, this NIS aims to collect long-term safety data in adult, adolescent and pediatric AD patients treated with dupilumab. Individual observation period is 2 years or until dupilumab is discontinued. Visits will be scheduled according to standard of care.
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Ficha completa en ClinicalTrials.gov (NCT06039241), actualizada en sep 2026.