Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as monoclonal antibody, ChAglyCD3, anti-CD3, TRX4
otelixizumab infusion plus physician determined standard of care · 1 trial · 1 indication
Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from Time 0 to 120 minutes, calculated using the trapezoidal rule. This reported AUC was normalized for time interval by dividing it by 120 minutes. This normalized AUC was calculated for each participant at Baseline, Week 12, and at Months 6, 12, 18, and 24. Data has been presented for meal stimulated C-peptide Area under assessment performed at Month 12. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Month 12.
| Arm | Type | Description |
|---|---|---|
| otelixizumab | EXPERIMENTAL | otelixizumab |
| placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| otelixizumab infusion plus physician determined standard of care | BIOLOGICAL | infusion |
| placebo infusion plus physician determined standard of care | BIOLOGICAL | infusion |
Inclusion Criteria: * Ages 12-45 * Diagnosis of diabetes mellitus, consistent with ADA criteria * No more than 90 days between diagnosis and administration of study compounds * Requires insulin for type 1 diabetes mellitus, or has required insulin at some time between diagnosis and administration o...
Otelixizumab infusion plus physician determined standard of care is an investigational treatment being studied in adults and adolescents with newly diagnosed Type 1 diabetes mellitus. It combines an infused monoclonal antibody with whatever standard of care the treating physician determines is appropriate for the patient. GSK plc is the developer.
It is being studied for Type 1 diabetes mellitus, specifically in adults and adolescents with newly diagnosed autoimmune Type 1 diabetes. The Phase 3 DEFEND-1 trial enrolled 272 participants aged 12 years and older across the United States, Canada, and several European countries.
GSK plc, which trades under the ticker GSK, is the developer of otelixizumab infusion plus physician determined standard of care. The company sponsored the Phase 3 DEFEND-1 trial evaluating the monoclonal antibody infusion alongside physician determined standard of care in Type 1 diabetes.
It is in Phase 3 development. The single registered trial, DEFEND-1, was a Phase 3 randomized, double-blind, placebo-controlled study that has been completed. It is an investigational therapy and is not described as approved for any indication.
The treatment was evaluated in NCT00678886, the DEFEND-1 trial, a Phase 3 study of otelixizumab for adults with newly diagnosed Type 1 diabetes mellitus. That trial is completed, enrolled 272 participants, was randomized and double-blind, and used a placebo control.