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
Phase of Trial: Phase III
Latest Information Update: 05 Dec 2019
Price : $35 *
At a glance
- Drugs Teplizumab (Primary)
- Indications Type 1 diabetes mellitus
- Focus Pharmacokinetics; Registrational
- Acronyms PROTECT
- Sponsors MacroGenics; Provention Bio
- 20 Aug 2019 According to the Provention Bio media release, Dr. Sherron Kell will lead the PRV-031 (teplizumab) program, including the oversight of this study and clinical support of anticipated regulatory submissions.
- 09 Apr 2019 According to the Provention Bio media release, If successful, this trial could serve as the basis for a Biologics License Application (BLA).
- 09 Apr 2019 According to the Provention Bio media release, company expects to complete enrollent by the end of 2020.