Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
Latest Information Update: 29 Apr 2024
At a glance
- Drugs Teplizumab (Primary)
- Indications Type 1 diabetes mellitus
- Focus Pharmacokinetics; Registrational
- Acronyms PROTECT
- Sponsors MacroGenics; Provention Bio
- 18 Oct 2023 Results assessing beta-cell preservation, clinical end points, and safety in children and adolescents who were assigned to receive teplizumab or placebo for two 12-day courses, published in the New England Journal of Medicine.
- 18 Oct 2023 According to a Sanofi media release, results were published in The New England Journal of Medicine.
- 18 Oct 2023 According to a Sanofi media release, results were presented at he 49th Annual ISPAD Conference, in Rotterdam, The Netherlands.