Trial Profile
Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized FcR Non-Binding Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 25 Oct 2023
Price :
$35
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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.