|
Synonyms: humanized OKT3 | MGA031 | PRV-031 | teplizumab-mzwv | Tzield®
teplizumab is an approved drug (FDA (2022))
Compound class:
Antibody
Comment: Teplizumab is a humanized anti-CD3e monoclonal antibody that was originally developed as an immunomodulatory agent. Structurally it is a modified version of the mouse antibody muromonab-CD3 (mOKT3) that has been used to reverse steroid-resistant renal allograft rejection. Alterations in the OKT3 CH2 domain disrupt Fcγ receptor binding, and blocks antibody-mediated effector cells functions and cytokine release [5,7]. It was advanced to extended clinical evaluations for potential to protect pancreatic β-cells in newly diagnosed type 1 diabetes (T1D) patients [4,6], following evidence that it impaired expansion of alloreactive anti-β cell T cells [5], and that a single short course of teplizumab treatment could induce a long-lasting improvement in patients' C-peptide responses and clinical parameters (including preservation of insulin production) in the early stages of T1D [2-3].
|
| No information available. |
Summary of Clinical Use  |
| Early clinical evidence indicated a propensity towards preventive efficacy in individuals at risk of developing type 1 diabetes [1]. Approved in 2022 to delay the onset of stage 3 type 1 diabetes. was investigated for anti-inflammatory activity in moderate to severe psoriasis, but injection site reactions lead to termination in this disease. |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT00954915 | Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis | Phase 1/Phase 2 Interventional | MacroGenics | ||
| NCT04598893 | Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab | Observational | Provention Bio, Inc. | ||
| NCT03875729 | Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab | Phase 3 Interventional | Provention Bio, Inc. | ||
| NCT00920582 | Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus | Phase 3 Interventional | MacroGenics | ||
| NCT01030861 | Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk" | Phase 2 Interventional | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 8 | |
