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Teplizumab · KIBOU-T1D

Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes

Ensayo de Sanofi en Diabetes tipo 1.

Más ensayos de: Diabetes tipo 1.

Fase

Fase 2

Estado

Reclutando pacientes

Participantes

10

previstos

Centros

11

Fin del objetivo primario

mar 2028

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jul 2025.

Qué mide

Number of participants with Stage 3 Type 1 Diabetes based on American Diabetes Association criteria (From baseline up to Week 104) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a parallel, Phase 2, two-arm study to assess the efficacy and safety of 14-days intravenous (IV) infusion of teplizumab treatment. Teplizumab has been approved by FDA to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. The dose regimen of teplizumab in this study is consistent with the regimen approved by US FDA. Given prior clinical studies conducted in Western countries, this design is appropriate to assess the efficacy, safety and tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of a 14-day IV infusion regimen of teplizumab in Japanese Stage 2 T1D participants aged 1 to 34 years.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06791291), actualizada en jun 2026.