Calendario›SNY›Dupilumab SAR231893
Dupilumab SAR231893
Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)
Ensayo de Sanofi en Urticaria cronica espontanea.
Más ensayos de: Urticaria crónica espontánea.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 397
- Centros
- 98
- Fin del objetivo primario
- ago 2024
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2019.
Qué mide
Change From Baseline in Weekly Itch Severity Score at Week 24 (Baseline (Day 1) and Week 24) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: This study aimed to demonstrate the efficacy of dupilumab in study participants with CSU who remained symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders) Secondary Objectives: This study aimed to demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints This study aimed to demonstrate the efficacy of dupilumab on angioedema This study aimed to demonstrate the efficacy of dupilumab on urticaria control This study aimed to demonstrate improvement in health-related quality of life and overall disease status and severity This study aimed to evaluate the ability of dupilumab in reducing the proportion of participants who require treatment with oral corticosteroids (OCS) This study aimed to evaluate safety outcome measures This study aimed to evaluate immunogenicity of dupilumab
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04180488), actualizada en ago 2025.