teplizumab
teplizumab: developed by 1 company · 9 clinical trials tracked.
teplizumab evidence translation
What we can confirm
9 tracked trials
What it means
What to watch
Prepared research question
How could teplizumab → PRVB affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence2 indications · 2 study sponsors
Related indications
Development Pipeline (1)
| Company | Phase |
|---|---|
| PROVENTION BIO, INC. (PRVB) delay of clinical type 1 diabetes (T1D) in at-risk individua… | BLA Filed |
Clinical Trials (9)
Adaptive Platform Trial to Delay Progression From Stage 2 to Stage 3 Type 1 Diabetes: Comparing Teplizumab With Low-dose Anti-Thymocyte Globulin (ATG) Protocol TN-40A
Primary endpoint: Change in DPTRS at six months
Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care
Primary endpoint: Time from teplizumab infusion start to the onset of Stage 3 T1D
A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
Primary endpoint: Participant demographics at teplizumab initiation
TEPLIzumab: QUality of Life Evaluation During Stage Transition
Primary endpoint: Change in participant and caregiver-reported outcomes from survey responses: ease of diabetes management questions
A Randomized, Double-blind, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Recently Diagnosed Stage 3 Type 1 Diabetes (T1D)
Primary endpoint: For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline
Efficacy and Safety of Teplizumab in the Treatment of Japanese Pediatric and Adult Participants Aged 1 to 34 Years With Stage 2 Type 1 Diabetes: A Multicenter, Randomized, Open-label, Controlled Study.
Primary endpoint: Number of participants with Stage 3 Type 1 Diabetes based on American Diabetes Association criteria
A Real-World Observational Study Characterizing Patients With Type 1 Diabetes Treated With Teplizumab
Primary endpoint: Participant demographic characteristics at teplizumab initiation
Single Arm, Open-label Study to Assess the Safety and Pharmacokinetics of a 14-day Regimen of Teplizumab in Pediatric Stage 2 Type 1 Diabetes (Participants <8 Years of Age With at Least Two Autoantibodies and Dysglycemia)
Primary endpoint: Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), TEAEs leading to withdrawal, and serious adverse events (SAEs)
A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Recent-Onset Type 1 Diabetes Mellitus
Primary endpoint: Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies
Frequently asked questions
Who is developing teplizumab?
teplizumab is being developed by PROVENTION BIO, INC..
How many clinical trials involve teplizumab?
BioSniper tracks 9 clinical trials involving teplizumab.