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 an investigational monoclonal antibody being studied for the treatment of Type 1 Diabetes Mellitus. It is intended for use in children and adults with recent-onset Type 1 Diabetes Mellitus. The drug is currently in clinical development and has not been approved by regulatory authorities.
Teplizumab is a monoclonal antibody that targets CD3, a protein on the surface of T cells. By binding to CD3, it modulates the activity of T cells, which are involved in the autoimmune destruction of insulin-producing beta cells in Type 1 Diabetes Mellitus.
Teplizumab is being developed by MacroGenics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MGNX. The company is conducting clinical trials to evaluate the safety and efficacy of Teplizumab in patients with Type 1 Diabetes Mellitus.
Teplizumab is in Phase 2 clinical development. It has completed one Phase 2 trial, the Protégé Study, which enrolled 554 participants. The drug is investigational and has not received FDA approval for any indication.
Teplizumab has been studied in the Protégé Study (NCT00385697), a Phase 2, randomized, double-blind, placebo-controlled trial in children and adults with recent-onset Type 1 Diabetes Mellitus. The trial enrolled 554 participants across multiple countries and has been completed.
Yes, Teplizumab is also known as MGA031. The Protégé Study, which evaluated Teplizumab, is titled 'Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus.' Both names refer to the same investigational monoclonal antibody.