At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 328 enrolled
Drug / intervention
teplizumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating teplizumab and Placebo for Type 1 Diabetes Mellitus. Completed, enrolled 328 participants across 62 sites in 9 countries.
Detailed Summary
The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.. Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesBelgium, Canada, Czechia, France, Germany, Hungary, Poland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 2019
Enrollment StartApr 2019
Primary CompletionMay 2023
TodayJul 2026
First PostedMar 15, 2019
Enrollment StartApr 5, 2019
Primary CompletionMay 1, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.3 years ago
Interventions
teplizumabbiological
Treatment
Placebobiological
Control