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: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2020-002798-92-PL

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: 200

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 6 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: 182
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
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

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