Calendario›SNY›Amlitelimab · ATLANTIS

Amlitelimab · ATLANTIS

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

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

Fase

Fase 2

Estado

En marcha, sin reclutar

Participantes

999

previstos

Centros

174

Fin del objetivo primario

jun 2031

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en abr 2023.

Qué mide

Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs) (Baseline up to end of study (EOS) (Week 284)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 284 weeks, including: * A screening period of up to 2 to 4 weeks * An open label treatment period of up to 268 weeks (approximately 5 years) * A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264) The planned number of visits will be 35 visits.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05769777), actualizada en abr 2026.