Calendario›REGN›Dupilumab

Dupilumab

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Ensayo de REGENERON PHARMACEUTICALS, INC. en Dermatitis atopica.

Más ensayos de: Dermatitis atópica.

Fase

Fase 3

Estado

Completado

Participantes

2.733

previstos

Centros

432

Fin del objetivo primario

jun 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en oct 2013.

Qué mide

Number of Treatment Emergent Adverse Events (TEAEs) (del registro, en inglés) (hasta 272 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01949311), actualizada en oct 2023.