Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2026-02-20 @ 2:49 PM
Study NCT ID:
NCT00946257
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2009-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subcutaneous Administration of Otelixizumab to T1DM Patients
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Randomised, Single-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Ascending Administration of Otelixizumab in Subjects With Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAO112438
Brief Summary:
This study will assess the subcutaneous administration of otelixizumab to T1DM patients. The study will provide safety, tolerability, pharmacodynamic and pharmacokinetic information which will enable the identification of appropriate safe and well-tolerated subcutaneous dosage regimens to be used in subsequent clinical studies. This study will consist of a screening phase, followed by an in-house phase whereby otelixizumab will be administered to cohorts that will be staggered at each dose level.
Detailed Description:
Otelixizumab is a humanized, aglycosyl, non-mitogenic, anti CD3 monoclonal antibody (MAb) directed against the ε domain of the human lymphocyte antigen CD3, which is currently undergoing phase III clinical trials in adult new-onset type I diabetes mellitus patients and has been evaluated in rheumatoid arthritis and psoriasis patients in small exploratory studies. In previous studies, otelixizumab has been administered by intravenous infusion. This study is a randomised, single-blind, placebo-controlled, study of otelixizumab administered subcutaneously in Type 1 Diabetes Mellitus (T1DM) subjects.
The assessment of otelixizumab in T1DM subjects will provide safety, tolerability, pharmacodynamic and pharmacokinetic information following subcutaneous administration which will enable the identification of appropriate safe and well-tolerated subcutaneous dosage regimens to be used in subsequent clinical studies. This study will consist of a screening phase, followed by an in-house phase whereby otelixizumab will be administered to cohorts that will be staggered at each dose level. Approximately 6 dose levels, covering up to a 10-fold dose range, will be evaluated. A single subcutaneous dose of otelixizumab will be administered on Day 1 and, serial blood samples will be obtained for clinical laboratory testing, determination of pharmacodynamic markers, serum otelixizumab PK parameters, and immunogenicity. Safety and pharmacodynamic data from the previous dose(s) will be evaluated prior to dose escalation or modification to ensure safety and to achieve target systemic peripheral blood pharmacology. Adverse events, laboratory values, vital signs and ECG's will be monitored closely during this study. All subjects in the study will undergo long-term follow-up out to 48 months to monitor and ensure patient safety.
The assessment of otelixizumab in T1DM subjects will provide safety, tolerability, pharmacodynamic and pharmacokinetic information following subcutaneous administration which will enable the identification of appropriate safe and well-tolerated subcutaneous dosage regimens to be used in subsequent clinical studies. This study will consist of a screening phase, followed by an in-house phase whereby otelixizumab will be administered to cohorts that will be staggered at each dose level. Approximately 6 dose levels, covering up to a 10-fold dose range, will be evaluated. A single subcutaneous dose of otelixizumab will be administered on Day 1 and, serial blood samples will be obtained for clinical laboratory testing, determination of pharmacodynamic markers, serum otelixizumab PK parameters, and immunogenicity. Safety and pharmacodynamic data from the previous dose(s) will be evaluated prior to dose escalation or modification to ensure safety and to achieve target systemic peripheral blood pharmacology. Adverse events, laboratory values, vital signs and ECG's will be monitored closely during this study. All subjects in the study will undergo long-term follow-up out to 48 months to monitor and ensure patient safety.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: