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Also known as teplizumab, Teplizumab
teplizumab/mL · 4 trials · 2 indications
TEAE: treatment-emerged adverse event; SAE: serious adverse event; AE: adverse event
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 | 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 |
| Teplizumab treated | EXPERIMENTAL | Administration of teplizumab by intravenous infusion for 12 consecutive days |
| Name | Type | Description |
|---|---|---|
| teplizumab | BIOLOGICAL | Treatment |
| Placebo | BIOLOGICAL | Control |
| 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: * 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/mL is being developed for Type 1 Diabetes Mellitus. It is a monoclonal antibody studied in people with recent-onset disease and in earlier stages of type 1 diabetes, including Stage 2 and Stage 3. The program is in Phase 3 development, with additional Phase 2 studies conducted in Japanese participants and in an at-risk extension study.
Teplizumab/mL targets CD3E, a component of the CD3 complex on T cells. Binding to CD3E modulates T cell activity, which is the proposed mechanism relevant to type 1 diabetes, a condition driven in part by autoimmune destruction of insulin-producing beta cells. The target class is classified as other.
Teplizumab/mL is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical development program for teplizumab/mL in Type 1 Diabetes Mellitus, a metabolic therapeutic area.
Teplizumab/mL is in Phase 3 development for Type 1 Diabetes Mellitus. It is an investigational monoclonal antibody and is not described as approved. The program includes Phase 3 and Phase 2 trials, with two studies currently recruiting and two completed.
Teplizumab/mL is being studied in several registered trials. NCT07088068 is a recruiting Phase 3 study comparing teplizumab with placebo in participants aged 1 to 25 years with Stage 3 type 1 diabetes. NCT06791291 is a recruiting Phase 2 study in Japanese participants with Stage 2 type 1 diabetes. Completed studies include NCT03875729 and NCT04270942.
Yes. Teplizumab/mL refers to the same agent as teplizumab, and it is also written as teplizumab 1 mg/mL. These names describe the same monoclonal antibody product developed by Sanofi for Type 1 Diabetes Mellitus, so searches using any of these names refer to the same drug asset.