Teplizumab for Pediatric Type 1 Diabetes

(PETITE-T1D Trial)

Recruiting at 20 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Provention Bio, a Sanofi Company

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests the safety of teplizumab, an IV medication, in children under 8 with early signs of type 1 diabetes. The drug aims to protect insulin-producing cells from immune system attacks and has shown potential in delaying the onset of type 1 diabetes.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

This trial is for children under 8 years old with Stage 2 Type 1 Diabetes, which means they have certain diabetes-related antibodies and blood sugar issues. Kids can't join if they have other autoimmune diseases (except stable thyroid or celiac), infections like HIV/HBV/HCV, or any condition that might affect the study or their safety.

Inclusion Criteria

I am under 8 years old.

I have Stage 2 Type 1 Diabetes with certain autoantibodies and blood sugar issues.

Exclusion Criteria

You have any autoimmune disease other than type 1 diabetes, except for stable thyroid or celiac disease.

You have had HIV, hepatitis B, or hepatitis C in the past or currently have evidence of these infections.

Has any condition that, in the opinion of the Investigator, would interfere with the study conduct or the safety of the participant

Treatment Details

Interventions

• Teplizumab (Monoclonal Antibodies)

Trial Overview The trial is testing teplizumab's safety and how it's processed in the body (pharmacokinetics) in young kids with early-stage Type 1 Diabetes to see if it could help manage their condition.

Participant Groups

Group I: teplizumab injection Experimental Treatment 1 Intervention

teplizumab injection, sterile solution for intravenous use

Who Is Running the Clinical Trial?

Provention Bio, a Sanofi Company

Lead Sponsor

Trials

5

Recruited

540+

Provention Bio, Inc.

Lead Sponsor

Trials

11

Recruited

1,300+