Calendario›SNY›Duvakitug · SUNSCAPE-2

Duvakitug · SUNSCAPE-2

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Ensayo de Sanofi en colitis ulcerosa.

Más ensayos de: Colitis ulcerosa.

Fase

Fase 3

Estado

Reclutando pacientes

Participantes

751

previstos

Centros

55

Fin del objetivo primario

sep 2028

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ene 2026.

Qué mide

Estudio de mantenimiento pivote cohorte 1: proporción de participantes que logran remisión clínica por puntuación de Mayo modificada (mMS). (semana 40)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visit will be up to 32: * 21 visits in the Pivotal Maintenance Sub-Study. * 11 visits in the OLE Sub-Study.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT07185009), actualizada en sep 2026.