Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Teplizumab · 1 trial · 1 indication
This is a composite endpoint is based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5% at 52 weeks after randomization.
This is a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5%
Comparison among study treatments of average change from baseline HbA1C. This endpoint will be assessed in a hierarchical manner only if the composite primary endpoint shows a statistically significant difference between arms
The average change in HbA1c levels after dosing.
| Arm | Type | Description |
|---|---|---|
| Double-blind Herold Regimen | EXPERIMENTAL | Full dose of teplizumab IV for 14 days, repeated at Week 26 |
| Double-blind 33.3% Herold Regimen | EXPERIMENTAL | One third full dose of teplizumab IV for 14 days, repeated at Week 26 |
| Double-blind Curtailed Herold Regimen | EXPERIMENTAL | Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 |
| Double-blind Placebo | PLACEBO_COMPARATOR | Placebo IV dosing daily for 14 days repeated at Week 26 |
| Open-label Herold Regimen | EXPERIMENTAL | Full dose of teplizumab IV for 14 days, repeated at Week 26 |
| Name | Type | Description |
|---|---|---|
| Teplizumab | BIOLOGICAL | Daily IV dosing for 14 days, repeated at Week 26 |
| Placebo | DRUG | Daily IV dosing for 14 days, repeated at Week 26 |
Inclusion Criteria: Subjects must meet all of the following criteria: 1. Enrollment (Segment #1) or randomization (Segment #2) on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes. Study Day 0 is the first day of study drug dosing. 2. Diagnosis of type 1...
Teplizumab is being studied for the treatment of type 1 diabetes mellitus. It is an investigational monoclonal antibody developed by MacroGenics, Inc. under the ticker MGNX. The clinical program has focused on children and adults with recent-onset type 1 diabetes.
Teplizumab targets CD3E, a component of the CD3 complex on T cells. By binding CD3E, the monoclonal antibody is designed to modulate T cell activity, which is the mechanism explored in type 1 diabetes, a condition driven in part by T cell mediated destruction of insulin-producing cells.
Teplizumab is developed by MacroGenics, Inc., which trades under the ticker MGNX. The company has studied the antibody under the designation MGA031 in its type 1 diabetes clinical program.
Teplizumab is in Phase 2 development for type 1 diabetes mellitus. It is an investigational agent and is not described as approved. The completed Phase 2 study enrolled 554 participants and was randomized, double-blind, and placebo-controlled.
Teplizumab has been evaluated in the Phase 2 Protégé Study, registered as NCT00385697, titled a clinical trial of MGA031 in children and adults with recent-onset type 1 diabetes mellitus. The trial is completed, enrolled 554 participants, and included sites across the United States, Canada, Europe, India, Israel, and Mexico.
Yes, MGA031 is an alternative designation for teplizumab. MacroGenics, Inc. used the name MGA031 in the Phase 2 Protégé Study, registered as NCT00385697, which evaluated the monoclonal antibody in children and adults with recent-onset type 1 diabetes mellitus.