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Dupilumab
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
Ensayo de Sanofi en Asma.
Más ensayos de: Asma.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 378
- Centros
- 81
- Fin del objetivo primario
- abr 2025
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en jun 2018.
Qué mide
Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs) (From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: * To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. * To evaluate the efficacy of dupilumab in children of 6 to \<12 years of age with uncontrolled persistent asthma in the Japan sub-study. Secondary Objectives: * To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. * To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: * Systemic exposure. * Anti-drug antibodies (ADAs). * Biomarkers. * To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study * To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to: * Systemic exposure, * Anti-drug antibodies (ADAs), * Biomarkers
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03560466), actualizada en nov 2025.