Calendario›SNY›Dupilumab SAR231893
Dupilumab SAR231893
Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)
Ensayo de Sanofi en Neurodermatitis (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 151
- Centros
- 63
- Fin del objetivo primario
- nov 2021
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2019.
Qué mide
Percentage of Participants With Improvement (Reduction) in Worst Itch Numeric Rating Scale (WI-NRS) Scores by Greater Than or Equal to (>=) 4 Points From Baseline to Week 24 (del registro, en inglés) (inicio y semana 24)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapies or when those therapies are not advisable. Secondary Objectives: To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN, inadequately controlled on topical prescription therapies or when those therapies are not advisable. To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in health-related quality of life. To evaluate safety outcome measures. To evaluate immunogenicity of dupilumab.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04183335), actualizada en sep 2025.