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Dupilumab SAR231893 · AIMS
Dupilumab in Allergic Fungal Rhinosinusitis (AFRS)
Ensayo de Sanofi en Allergic Fungal Rhinosinusitis (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 62
- Centros
- 47
- Fin del objetivo primario
- dic 2024
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2020.
Qué mide
Change From Baseline to Week 52 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score (Baseline (Day 1) and Week 52) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: * To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) Secondary Objectives: * To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) at Week 24 * To assess the efficacy of dupilumab to reduce the need for rescue treatments * To evaluate the efficacy of treatment with dupilumab in improving symptoms in AFRS * To evaluate the efficacy of dupilumab to reduce nasal polyp formation in participants with AFRS * To evaluate the efficacy of dupilumab in improving overall symptom severity and quality of life in AFRS * To evaluate the efficacy of dupilumab in improving sense of smell in participants with AFRS * To explore the effect of dupilumab as assessed by three-Dimensional CT volumetric measurement of the paranasal sinuses * To evaluate the safety and tolerability of dupilumab when administered to participants with AFRS * To evaluate the pharmacokinetics (PK) of dupilumab in participants with AFRS * To characterize the effect of dupilumab on total IgE and specific IgE * To assess immunogenicity to dupilumab in participants with AFRS
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04684524), actualizada en ago 2026.