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Dupilumab · BALISTAD-CN

Dupilumab Skin BArrier Function and LIpidomics STudy in Atopic Dermatitis in China

Ensayo de Sanofi en Atopic Dermatitis · Dermatitis Atopic (del registro, en inglés).

Más ensayos de: Dermatitis atópica.

Fase

Fase 4

Estado

Completado

Participantes

44

previstos

Centros

1

Fin del objetivo primario

ene 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en nov 2022.

Qué mide

Percent change from baseline in TEWL after 5 skin tape stripping (STS) assessed on lesional skin at Week16 in AD patients. (From baseline to week16) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a 16-week, open label, exploratory study designed to investigate dupilumab's effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping. During the first 2 treatment weeks, patients will have 2 on-site visits/week, followed by one on-site visit/week up to Week 4, one on-site visit every two weeks from Week 4 to Week 8, and one on-site visit every 4 weeks up to Week 16 End of Treatment phase visit (EoT) thereafter. A follow-up visit by phone 4 weeks after the last study assessment at Week 16 will end the study for each participant (End of Study: EoS). The maximum duration of the study per participant will be 24 weeks.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05624112), actualizada en sep 2025.