Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule

연구 개요

This 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.