Calendario›SNY›Amlitelimab
Amlitelimab
A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
Ensayo de Sanofi en Coeliac Disease · Celiac Disease (del registro, en inglés).
- Fase
- Fase 2
- Estado
- En marcha, sin reclutar
- Participantes
- 229
- Centros
- 118
- Fin del objetivo primario
- ago 2026
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ago 2024.
Qué mide
Change in Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28 (del registro, en inglés) (del inicio a la semana 28)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a Phase 2a/b, randomized, double-blind, placebo-controlled, parallel-group, 6-arm study to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease (NRCD) who are on a gluten free diet (GFD) with and without simulated inadvertent gluten exposure (SIGE). The primary purpose of this study is to demonstrate the efficacy of subcutaneous (SC) amlitelimab in male and female participants (aged 18 to 75 years, inclusive) with NRCD. The study will assess the effect of amlitelimab when compared to placebo on gluten induced changes in the intestinal mucosa as measured by the villous height to crypt depth (Vh:Cd) ratio. The effect of amlitelimab on participant-reported celiac signs and symptoms along with the safety, tolerability, and pharmacokinetics of amlitelimab will also be studied. Study details include: The study duration will be up to 48 weeks (including a 16-week safety follow-up period) with 10 visits for participants who opt not to enter the optional long-term extension. The study duration will be up to 172 weeks (including an 8-week safety follow-up period) with 22 visits for participants who enter the optional long-term extension. The double-blind placebo-controlled treatment duration will be up to 28 weeks.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06557772), actualizada en ago 2026.