Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385697
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2006-10-07
Brief Title:
The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Sponsor:
MacroGenics
Organization:
MacroGenics
Study Overview
Official Title:
A Phase 23 Randomized Double-Blind Multicenter Multinational 4-Arm Controlled Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031 a Humanized FcR Non-Binding Anti-CD3 Monoclonal Antibody in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2023-11
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:
None
Brief Summary:
The primary purpose of this protocol is to assess the efficacy tolerability and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset diagnosis within past 12 weeks type 1 diabetes mellitus All regimens will be administered as an addition to insulin and other standard of care treatments Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce typical insulin requirements while maintaining relatively normal blood sugar levels
Other studies involving the study drug use the name hOKT3γ1 Ala-Ala MGA031 a humanized monoclonal antibody is the name used for hOKT3γ1 Ala-Ala that is produced by MacroGenics Inc The United States Adopted Name USAN for MGA031 is teplizumab
Other studies involving the study drug use the name hOKT3γ1 Ala-Ala MGA031 a humanized monoclonal antibody is the name used for hOKT3γ1 Ala-Ala that is produced by MacroGenics Inc The United States Adopted Name USAN for MGA031 is teplizumab
Detailed Description:
The Protégé Study - A Multinational Clinical Trial of MGA031 for Preserving the Capability to Produce Insulin Reducing Insulin Usage and Improving Blood Sugar Levels in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None