Mobile

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-002457-69

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

Femme et Homme

  • | Pays :
    • -
  • | Organes :
    • -
  • | Spécialités :
    • -

Extrait

The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, and safety of teplizumab when administered according to 3 different teplizumab dosing regimens in subjects with recent-onset (onset within the past 12 weeks) type 1 diabetes. All regimens will be administered in addition to standard of care.

Critère d'inclusion

  • Recent-onset type I diabetes mellitus (T1DM)

Liens