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Also known as Teplizumab
teplizumab/mL · 1 trial · 1 indication
An AE was any untoward medical occurrence in a participant or clinical study participant,temporally associated with use of study dose,whether or not considered related to study dose.AESI was any AE that met any of following:All \>=Grade 3 infections (including all opportunistic infections);acute mononucleosis-like illness;lymphomas or other malignancies;severe hypoglycemic episode;\>=Grade 3 liver function abnormalities, thrombocytopenia, neutropenia or rash;\>= Grade 4 allergic/hypersensitivity reaction (anaphylaxis) or cytokine-release syndrome; lymphocyte count \<500/cubic millimeter for 7 days or longer. An SAE was as any untoward medical occurrence that,at any dose:resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization,resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or any other medically important event.A TEAE was any AE which started during or after the first dose of teplizumab.
| Arm | Type | Description |
|---|---|---|
| Teplizumab treated | EXPERIMENTAL | Administration of teplizumab by intravenous infusion for 12 consecutive days |
| Name | Type | Description |
|---|---|---|
| teplizumab 1 mg/mL | DRUG | Solution for infusion administered as IV infusion (anti-CD3 humanized monoclonal antibody). Cumulative dose: 9 mg/m2. Day 1: 106 μg/m2, Day 2: 425 μg/m2, Days 3-12: 850 μg/m2 daily |
Inclusion Criteria: 1. Previous participant in the TN-10 study 2. Participant had received a diagnosis of type 1 diabetes after the conclusion of the TN-10 study, according to the criteria from the American Diabetes Association (ADA). 3. Participant was able to initiate teplizumab treatment require...
Teplizumab is an investigational monoclonal antibody being developed for Type 1 Diabetes Mellitus. It is studied in people at risk for the disease, including those with Stage 2 Type 1 Diabetes, and in patients with recent-onset or Stage 3 Type 1 Diabetes. It is not yet approved and remains in clinical development.
Teplizumab is a monoclonal antibody of the -mab class. It is designed to modulate the immune system in Type 1 Diabetes Mellitus, though its specific molecular target is not disclosed in the available data. The drug is being studied for its effects on disease progression.
Teplizumab is being developed by Sanofi, a company traded under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's efficacy and safety in Type 1 Diabetes Mellitus across multiple countries, including the United States, Japan, and European nations.
Teplizumab is in Phase 3 clinical development. It is being studied in a Phase 3 trial for Stage 3 Type 1 Diabetes, and earlier-phase trials have been completed or are ongoing. The drug is investigational and has not been approved by regulatory authorities.
Teplizumab is being studied in several trials. NCT07088068 is a Phase 3 trial in patients aged 1 to 25 with Stage 3 Type 1 Diabetes. NCT06791291 is a Phase 2 trial in Japanese participants with Stage 2 disease. NCT03875729 and NCT04270942 are completed trials.
Teplizumab is the primary name used for this drug in clinical trials. No alternative names have been reported in the available data. It is consistently referred to as teplizumab across all studies, including those conducted by Sanofi.