T helper 17 cells and interleukin-17 immunity in type 1 diabetes: From pathophysiology to targeted immunotherapies

Table 2 Summary of the main ongoing clinical studies of Th17- and interleukin-17-targeted therapies in patients with new-onset type 1 diabetes

Study name	Study status and planned number of participants	Country	Study type	Study outcomes	ClinicalTrials.gov ID
Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2)	Recruiting; 66 adults	Canada	Randomized, placebo-controlled, double-blinded, multicenter phase II/II study conducted on 66 adult subjects (18-35 yr old) with recent-onset T1D. Ustekinumab is a fully human monoclonal antibody binding to the shared p40 subunit of IL-12 and IL-23, thus targeting the development of Th1 cells and Th17 cells. Planned study duration: Patients will be followed for 78 wk after the administration of the first ustekinumab dose. There will be a total of 10 study visits over the 78-wk period, three of which will be non-dosing and follow-up visits	Assessment of the efficacy of ustekinumab in counteracting the decline in mixed meal-stimulated C-peptide values in adult patients with recent-onset T1D	NCT03941132
Ixekizumab Diabetes Intervention Trial (I-DIT)	Recruiting; 127 patients	Sweden	Double-blind, placebo-controlled prospective phase 2 trial conducted on adult patients with newly diagnosed T1D. Planned study duration: 52 wk	Assessment of the efficacy of ixekizumab (an anti-IL-17A humanized monoclonal antibody) in counteracting the decline in mixed meal-stimulated C-peptide values in adult patients with newly diagnosed T1D	NCT04589325

T1D: Type 1 diabetes; IL: Interleukin; Th: T helper.