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Label indication TZIELD is indicated to [see Dosage and Administration (2.1) ]: Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D. Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. FDA label
Also known as SAR446681, TZIELD
Teplizumab · 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 is an investigational biologic being developed for Type 1 Diabetes Mellitus. It is being studied in people with Stage 2 and Stage 3 type 1 diabetes, including a Phase 3 trial in participants 1 to 25 years of age with Stage 3 disease. It has not been established as an approved therapy in the supplied information.
Teplizumab targets CD3E, a component of the CD3 complex on T cells. Binding to CD3E is the mechanism described for this biologic in type 1 diabetes research. The target class is listed as OTHER, and the drug is being developed as a biologic for the metabolic therapeutic area.
Teplizumab is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor associated with the clinical development program for teplizumab in Type 1 Diabetes Mellitus, a metabolic indication.
Teplizumab is in Phase 3 clinical development for Type 1 Diabetes Mellitus. The program includes a recruiting Phase 3 trial and a completed Phase 3 trial, along with Phase 2 studies. It is investigational and is not described as FDA approved in the available information.
Teplizumab trials include NCT07088068, a recruiting Phase 3 study in Stage 3 type 1 diabetes with 723 participants across many countries, and NCT03875729, a completed Phase 3 recent-onset trial with 328 participants. Phase 2 studies include NCT06791291 in Japanese participants with Stage 2 disease and NCT04270942, a completed extension study.