Dataset from Effects of Canakinumab On The Progression of Type 1 Diabetes In New Onset Subjects

Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1
class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the
bioactivity of this pro-inflammatory cytokine.

The study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical
trial. 66 subjects will be randomly assigned to receive either monthly subcutaneous
injections of 2.0 mg/kg Canakinumab, or placebo for 12 months. All groups will receive
standard intensive diabetes treatment with insulin and dietary management.

Participants randomly assigned to Canakinumab treatment or placebo will receive a total of 12
injections over one year.

All subjects will be followed for 1 year of treatment plus 1- 3 years of additional follow-up
until study end. Enrollment is expected to occur over two years.