Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab (PROTECT)

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Editor’s Note: On March 16, Provention Bio announced a temporary pause in the randomization of patients with newly diagnosed type 1 diabetes (T1D) into its global Phase 3 PROTECT study of teplizumab. “This pause is being taken out of an abundance of caution to protect patients, caregivers, clinical site staff, company employees and contractors at this critical juncture in the collective global efforts to combat the COVID-19 pandemic.” Beyond Type 1 is following closely and will update when trial enrollment and randomization resumes. 

Sponsored by Provention Bio, Inc.


Focus Area: Immunotherapies

What is This Study?

This Phase 3 study is to determine whether Teplizumab, an immune therapy drug preserves the loss of beta cells among children and adolescents 8-17 years old who have been diagnosed with Type 1 diabetes in the last three years. The cohort of up to 300 enrollees will be randomized 2:1 with 2/3 of the group receiving teplizumab and 1/3 of the group receiving a placebo.

Why do We Care?

Study results of Teplizumab presented at ADA in 2019 were among the most groundbreaking research presented of the conference. The drug was shown to delay the diagnosis of Type 1 diabetes an average of 2 years. While this trial is recruiting those who have already been diagnosed with T1D, preservation of Beta cells would help extend the honeymoon period, and potentially lead to a way to dull the immune response and cure T1D in the future.

When Might we See Results?

The estimated study date of May 2022 will likely be pushed back as a result of the ongoing COVID-19 pandemic. This page will be updated when trial enrollment and randomization resumes.

Further Reading

Preventing Type 1 Diabetes: Results From TrialNet’s Landmark Teplizumab Trial


The immunotherapy drug teplizumab was shown to delay Type 1 diabetes diagnosis a median of 2 years in children and adults at high risk.READ MORE

Stay tuned for in-depth coverage from Beyond Type 1 on the results of this study. To learn more about this trial, click here

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