Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab (PROTECT)
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|ClinicalTrials.gov Identifier: NCT03875729|
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : June 1, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Biological: teplizumab Biological: Placebo||Phase 3|
This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center study to evaluate the efficacy and safety of teplizumab, a humanized, anti-CD3 monoclonal antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1 diabetes (within 6 weeks of diagnosis). Approximately 300 participants will be randomized at a ratio of 2:1 to either the teplizumab group or the placebo group.
Teplizumab or matching placebo will be administered in two courses 6 months apart. Each course of treatment will include daily infusions for 12 days. The total study duration for each participant will be up to 86 weeks.
The primary objective is to determine whether two courses of teplizumab administered 6 months apart slows the loss of β cells and preserves β cell function over 18 months (78 weeks) in children and adolescents 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.
The secondary objectives are to evaluate improvements in key clinical parameters of diabetes management, to determine the safety and tolerability of teplizumab, and to evaluate the pharmacokinetics (PK) and immunogenicity of teplizumab
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase 3, randomized, double-blind, placebo-controlled, multinational, multicenter study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized FcR Non-Binding Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes|
|Actual Study Start Date :||April 5, 2019|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
Sterile solution for injection.
Placebo Comparator: Placebo
Sterile solution for injection
- The area under the time-concentration curve (AUC) of C-peptide after a mixed meal tolerance test (MMTT) at Week 78 [ Time Frame: Week 78 ]Clinical Endpoint
- Exogenous insulin use [ Time Frame: Week 78 ]Clinical Endpoint
- HbA1c levels [ Time Frame: Week 78 ]Clinical Endpoint
- Time in glycemic target range [ Time Frame: Week 78 ]Clinical Endpoint
- Clinically important hypoglycemic episodes [ Time Frame: Week 78 ]Clinical Endpoint
- Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) [ Time Frame: Up to Week 52 and Week 78 ]Safety Endpoint
- Teplizumab serum concentrations [ Time Frame: 78 Week ]PK Endpoint
- Incidence and titers of anti-teplizumab antibodies after treatment courses [ Time Frame: 78 Week ]Immunogenicity Endpoint
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875729
|Study Director:||Provention Bio, MD||Provention Bio, Inc.|