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Amlitelimab · HYDRO

A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo

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

Fase

Fase 2

Estado

Completado

Participantes

224

previstos

Centros

57

Fin del objetivo primario

oct 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en oct 2023.

Qué mide

Percentage of participants with a positive tetanus response at Week 16 (del registro, en inglés) (semana 16)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of amlitelimab concurrently administered with non-live vaccines in adult participants with moderate-to-severe atopic dermatitis (AD). The purpose of this study is to compare the immune responses to concomitantly administered Boostrix (tetanus, diphtheria, and acellular pertussis \[Tdap\]) and Pneumovax 23 (PPSV) vaccines in adult participants with moderate-to-severe AD treated with amlitelimab versus placebo. The study will evaluate the percentage of participants achieving a positive anti-tetanus response at Week 16 (primary endpoint) and a positive anti-pneumococcal response at Week 16 (key secondary endpoint). Study details include: The study duration will be up to 36 weeks (for participants not entering the LTS17367 \[RIVER-AD\]). The screening period will be 9 days to 4 weeks. The treatment duration will be up to 16 weeks. The post-treatment safety follow-up period will be16 weeks. The number of visits will be up to 7 (or 6 for those entering LTS17367 \[RIVER-AD\]).

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06015308), actualizada en ago 2026.