Investigating Re-Dosing With Otelixizumab in Adults With Newly-Diagnosed Type 1 Diabetes Mellitus
The purpose of this study to assess the safety and tolerability of re-dosing at 6 months with otelixizumab (given as an 8-day series of intravenous infusions) in adult subjects with newly diagnosed type 1 diabetes mellitus
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Safety and Tolerability of Re-dosing With Intravenous (iv) Otelixizumab in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus|
- Safety and tolerability (adverse events, change from baseline in vital signs, clinical chemistry and haematology parameters, epstein-barr virus load, change in total lymphocytes, CD4+ and CD8+ T-cell counts and immunogenicity) [ Time Frame: Month 24 ] [ Designated as safety issue: Yes ]
- Pharmacodynamics: circulating peripheral T lymphocytes and CD4+ and CD8+ subset counts [ Time Frame: Study Day 1 to Study Day 8 and Study Day 168 to Study Day 175 ] [ Designated as safety issue: Yes ]
- Pharmacodynamics: saturation of CD3 antigen on peripheral blood T cells [ Time Frame: Study Day 1 to Study Day 8 and Study Day 168 to Study Day 175 ] [ Designated as safety issue: No ]
- Pharmacokinetics: serum concentrations of otelixizumab [ Time Frame: Study Day 1 to Study Day 8 and Study Day 168 to Study Day 175 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||April 2013|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Two treatment courses of otelixizumab given 6 months apart. Each treatment course will consist of 8 consecutive days of otelixizumab intravenous infusions (each given over 30 minutes).
The primary objective of this phase IIa, open-label, multi-centre study is to assess the safety, tolerability and immunogenicity of re-dosing at 6 months with an 8 consecutive day series of otelixizumab intravenous (IV) infusions in 8 adult subjects with newly diagnosed type 1 diabetes mellitus (T1DM). Although it is hoped that the β cell preserving effect of otelixizumab will be long-lasting, it is possible that the effect may decline over time and thus T1DM subjects may require re-treatment. Six months is the minimum time expected between treatments.
After baseline assessments, eligible subjects will receive 8 consecutive days of otelixizumab infusions, each given over a 30 minute period. Prophylaxis for cytokine release syndrome AEs will be given. At Month 6, following a review of any new medical conditions, concomitant medications, lymphocyte count, Epstein Barr Virus (EBV) viral load and other re-dosing eligibility criteria, subjects will be re-treated with the same dosing regimen. Subjects will be followed for 24 months in this study.
|GSK Investigational Site|
|Paris Cedex 18, France, 75877|
|GSK Investigational Site|
|Leipzig, Sachsen, Germany, 04103|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|