At a glance
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Effects of Canakinumab On The Progression of Type 1 Diabetes In New Onset Subjects
In Brief
A Phase 2 clinical trial evaluating canakinumab (anti IL-1beta) and Placebo for Type 1 Diabetes and 3 related conditions. Completed, enrolled 71 participants across 12 sites in 2 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
Placebo subcutaneous injections