Calendario›SNY›Dupilumab
Dupilumab
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
Ensayo de Sanofi en Sibilancias · Asma.
Más ensayos de: Asma.
- Fase
- Fase 3
- Estado
- Reclutando por invitación
- Participantes
- 90
- Centros
- 74
- Fin del objetivo primario
- dic 2028
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en ene 2024.
Qué mide
Parte A: Tasa anualizada de exacerbaciones graves de asma durante el periodo de tratamiento de 52 semanas (del inicio a la semana 52)
Qué se prueba
Se evalua dupilumab frente a placebo en ninos de 2 a menos de 6 anos con asma no controlada o sibilancias asmaticas graves recurrentes.
Lo que dice el documentoto evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze.
Traducción automática (claude-sonnet-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 parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \<6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase. Study details include: Part A: The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period). Part B: For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A \[4-week Screening and a 52-week treatment period\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06191315), actualizada en ago 2026.