USTEKID: Ustekinumab in adolescents with recent-onset type 1 diabetes
Multicenter double-blind randomized phase-2 trial of ustekinumab in adolescents with recent-onset T1D. It met its 12-month C-peptide endpoint with no increase in adverse events.
Primary endpoints
- Stimulated C-peptide at 12 months
Results so far
Completed. ISRCTN14274380 last edited 1 September 2025: no longer recruiting; overall status completed. 72 adolescents were randomised (Nature Medicine); the NIHR report's analysable sample was n=62. Stimulated C-peptide was 49% higher in the ustekinumab group at 12 months (geometric ratio 1.49; 95% CI 1.08 to 2.06; P=0.02), with no increase in adverse events. That published paper is the result — the registry itself does not post outcome tables.
The full picture
USTEKID is the published adolescent signal that made ustekinumab worth tracking: positive 12-month C-peptide preservation, tolerability that looks acceptable, and a plausible Th17.1-linked mechanism.