Administration of Low-dose IL-2 in Established T1D
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
Randomized, controlled, double blinded, multicenter, phase I/II clinical trial to evaluate
the safety of low-dose IL-2 and to test whether low-dose IL-2 can prevent further loss of
beta-cell function in patients with established T1D, or even potentially improve ß-cell
function in such individuals, when IL-2 is given for one year (primary outcome). Equally
important, the study will carefully examine various effects of low-dose IL-2 on the immune
system in patients with T1D, including effects on Treg and other cell subsets, and
disease-specific autoimmune responses.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Jay S. Skyler
Collaborators:
Diabetes Research Institute Foundation National Institute of Allergy and Infectious Diseases (NIAID) University of California, San Francisco University of Florida