A Single Blind, Randomised, Placebo Controlled, Repeat Dose, Dose Escalating Study Investigating Safety, Tolerability Pharmacokinetics, Pharmacodynamics and the Beta-Cell Preserving Effect of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients

Trial Profile

A Single Blind, Randomised, Placebo Controlled, Repeat Dose, Dose Escalating Study Investigating Safety, Tolerability Pharmacokinetics, Pharmacodynamics and the Beta-Cell Preserving Effect of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 18 Jul 2017

At a glance

  • Drugs Otelixizumab (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Adverse reactions
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 19 Jun 2017 Planned End Date changed from 26 Sep 2018 to 27 Sep 2021.
    • 10 Jun 2017 Biomarkers information updated
    • 24 Feb 2017 Time frame of primary endpoints INCIDENCE ADVERSE EVENTS RELATED TO CYTOKINE RELEASE SYNDROME (CRS) has been changed from Upto 6 months to Upto 24 months and Time frame of EPSTEIN-BARR VIRUS (EBV) REACTIVATION has been changed from Day 21 to Month 24 to Day -1, Day 6 and 21, week 6, Month 2, 3, 6 and 24.
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