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Brivekimig · T1D OBTAIN
Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule
Ensayo de Sanofi en Diabetes tipo 1.
Más ensayos de: Diabetes tipo 1.
- Fase
- Fase 2
- Estado
- En marcha, sin reclutar
- Participantes
- 84
- Centros
- 24
- Fin del objetivo primario
- abr 2027
previstos
estimado por el promotor
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en feb 2025.
Qué mide
Change from baseline to Week 26 in mean 2-hour mixed meal tolerance test (MMTT) stimulated C-peptide concentration (From Baseline to Week 26) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a randomized, placebo-controlled, parallel group, multicenter, double-blind Phase 2a, 2-arm study. The goal of this Phase 2a study is to assess safety and efficacy of brivekimig in comparison to placebo to preserve β-cell function in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) on insulin therapy. The study design comprises 2 parts: in Part A adult participants (18 to 35 years of age at screening) and in Part B adolescent and young adult participants (age range 12 to 21 years) will be randomized into brivekimig and placebo groups. Approximately 84 participants will be included with randomization ratio 3:1 (active:placebo). The study includes a screening period (3 to 5 weeks), a double-blind treatment period of 52 weeks and a safety follow-up of 26 weeks.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06812988), actualizada en mar 2026.