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teplizumab · 3 trials · 1 indication
TEAE: treatment-emerged adverse event; SAE: serious adverse event; AE: adverse event
| Arm | Type | Description |
|---|---|---|
| Teplizumab | EXPERIMENTAL | Participants will receive teplizumab in increasing doses by intravenous administration |
| Placebo | PLACEBO_COMPARATOR | Participants will receive volume matching placebo doses to the Teplizumab arm by intravenous administration |
| Control | NO_INTERVENTION | Participants will receive no treatment in the control group |
| Name | Type | Description |
|---|---|---|
| teplizumab | BIOLOGICAL | Treatment |
| Placebo | BIOLOGICAL | Control |
Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: * Participant must be 1 to 25 years of age inclusive, at the time of signing the informed consent. * Participants diagnosed with T1D Stage 3 according to American Diabetes Associ...
Teplizumab is an investigational monoclonal antibody being developed for Type 1 Diabetes Mellitus. It is studied in people with recent-onset Type 1 diabetes, those at risk for the disease, and Japanese participants with Stage 2 Type 1 diabetes. It is not yet approved and remains in clinical development.
Teplizumab targets CD3E, a component of the CD3 receptor complex on T cells. By binding to CD3E, it modulates the immune response that destroys insulin-producing beta cells in Type 1 diabetes. This mechanism aims to preserve beta cell function and slow disease progression.
Sanofi (ticker: SNY) is developing teplizumab. The company is conducting Phase 3 and Phase 2 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 for Type 1 Diabetes Mellitus. It is also being studied in Phase 2 trials. The drug is investigational and has not been approved by regulatory authorities. Its development includes trials in recent-onset and at-risk populations.
Teplizumab is being studied in several trials. NCT03875729 is a completed Phase 3 trial in recent-onset Type 1 diabetes. NCT04270942 is a completed Phase 2 extension study in at-risk individuals. NCT06791291 is a recruiting Phase 2 trial in Japanese participants with Stage 2 disease. NCT07088068 is a recruiting Phase 3 trial in Stage 3 Type 1 diabetes.
Teplizumab is also known by its ChEMBL identifier CHEMBL1743078. No other alternative names are provided in the available information. Researchers and investors should refer to the drug as teplizumab when searching for clinical data and development updates.