ACZ885 in Type 1 Diabetes Mellitus

A Randomized, Double-blind, Multiple-dose, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ACZ885 in Patients With Newly Diagnosed Type-1 Diabetes Mellitus (T1DM)

This study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.

Inclusion Criteria:

• diagnosis of type 1 diabetes within 3 months of visit 1 and on a stable insulin regimen
• presence of at least one diabetes-related autoantibody
• qualifying C-peptide value in a mixed meal test at visit 1
• willing to not have vaccination with a live vaccine for 18 months, from 3 months before visit 1 until 3 months after the last dose of study drug
• body weight of at least 30 kg

Exclusion Criteria:

• women of child-bearing potential unless a highly effective method of birth control is used (such as combined oral contraceptives, intrauterine devices, etc)
• immunodeficiency
• active infections or febrile illness within 3 days before visit 1
• major dental work within 8 days before visit 1
• positive test for tuberculosis at visit 1
• use of medications other than insulin for the treatment of diabetes Other protocol-defined inclusion/exclusion criteria may apply