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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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)
Study Start Date
Estimated Primary Completion Date
Resource links provided by the National Library of Medicine
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Ages Eligible for Study:
6 Years to 35 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
women of child-bearing potential unless a highly effective method of birth control is used (such as combined oral contraceptives, intrauterine devices, etc)
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