Summary:

This is a randomized, placebo-controlled, double-blinded, multicenter phase II/II study to assess efficacy and safety of Ustekinumab (STELARA®) in participants with T1D. We will perform a phase II/III clinical trial with a total of 66 adult (18-25 years old) subjects with recent-onset T1D. There will be two study cohorts, with a drug:placebo ratio of 2:1. Participants receiving the study drug will receive a loading dose of 6mg/kg Ustekinumab IV given at week 0. Thereafter, 90mg Ustekinumab subcutaneously given at weeks 8, 16, 24, 32, 40, 48 (total of 7 doses). Participants randomized to receive placebo will receive respective amounts of a saline-placebo.