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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516543-26-00
Acronym
PRV-031-003/LTS18119
Enrollment
66
Registered
2024-10-10
Start date
2021-07-23
Completion date
Unknown
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Brief summary

Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies

Detailed description

The area under the time-versus-concentration curve (AUC) of C-peptide after a 4-hour (4h) mixed-meal tolerance test (MMTT), a measure of endogenous insulin production and β cell function by visit and change from baseline (MMTT), a measure of endogenous insulin production and β cell function, Insulin use, defined as a daily average dose in units per kilogram per day (U/kg/day) by visit and change from baseline, HbA1c levels(%) by visit and change from baseline

Interventions

DRUGTeplizumab

Sponsors

Provention Bio Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies—

Secondary

MeasureTime frame
The area under the time-versus-concentration curve (AUC) of C-peptide after a 4-hour (4h) mixed-meal tolerance test (MMTT), a measure of endogenous insulin production and β cell function by visit and change from baseline (MMTT), a measure of endogenous insulin production and β cell function, Insulin use, defined as a daily average dose in units per kilogram per day (U/kg/day) by visit and change from baseline, HbA1c levels(%) by visit and change from baseline—

Countries

Belgium, Czechia, France, Germany, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026