Calendario›SNY›Amlitelimab · ESTUARY
Amlitelimab · ESTUARY
A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal 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 3
- Estado
- En marcha, sin reclutar
- Participantes
- 1.541
- Centros
- 324
- Fin del objetivo primario
- jun 2026
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en may 2024.
Qué mide
US and US reference countries: Proportion of participants who are responders AND maintained vIGA-AD ≤2 without experiencing relapse among participants who were responders at baseline of ESTUARY (del registro, en inglés) (semana 24)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD). The primary objective of ESTUARY is to assess the maintenance of treatment response on continued Q12W dosing compared to treatment withdrawal. Study details include: The study duration will be up to 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD). The study duration will be up to 52 weeks for participants entering the LTS17367 \[RIVER-AD\] study at the Week 52 visit of EFC17600 (ESTUARY).
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06407934), actualizada en jul 2026.