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SAR441566 · SPECIFI-CD

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.

Ensayo de Sanofi en Enfermedad de Crohn.

Más ensayos de: Enfermedad de Crohn.

Fase

Fase 2

Estado

En marcha, sin reclutar

Participantes

260

previstos

Centros

141

Fin del objetivo primario

jul 2026

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2024.

Qué mide

Proportion of participants achieving endoscopic response (del registro, en inglés) (semana 12)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD. This study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment for participants not enrolling in the Long Term Safety (LTS) study. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06637631), actualizada en sep 2026.