Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab

Phase 1

Conditions: Type 1 Diabetes (T1D)
MedDRA version: 20.0Level: LLTClassification code 10012594Term: DiabetesSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2020-002798-92-CZ

Lead Sponsor: Provention Bio, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 188

Inclusion Criteria

1. Completion of the PRV-031-001 (PROTECT) study by completing the Week 78 visit in that study, regardless of how many doses of study drug were administered.
2. Provide written informed consent within 12 months of the Week 78 in the PRV-031-001 study. Written assent will be obtained for participants under 18 years of age at the time of enrollment, according to applicable regulations. If possible, written informed consent and/or assent for the current PROTECT Extension study (PRV-031-003) should be obtained at the final (Week 78) visit in the PROTECT study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 175
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Premature discontinuation from the PRV-031-001 study for any reason.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety of teplizumab in participants who previously completed the PRV-031-001 (PROTECT) study for an additional 42 months of follow-up;Secondary Objective: To evaluate clinical parameters of diabetes management, including insulin use and HbA1c, during the 42 months of follow-up;Primary end point(s): Incidence of adverse events (AEs) and serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies;Timepoint(s) of evaluation of this end point: Month 42

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • 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 ß cell function<br>• Insulin use, defined as a daily average dose in units per kilogram per day (U/kg/day)<br>• HbA1c levels;Timepoint(s) of evaluation of this end point: Month 42