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Monoclonal Antibodies

Teplizumab for Pediatric Type 1 Diabetes (PETITE-T1D Trial)

Phase 4
Recruiting
Research Sponsored by Provention Bio, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is a male or female 0 to < 8 years of age, inclusive, at Day 1
Participant has Stage 2 T1D (two T1D-related autoantibodies and dysglycemia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up sparse pk samples between days 1 and 28
Awards & highlights

PETITE-T1D Trial Summary

This trial tests a drug to treat type 1 diabetes in children under 8 years old, to check its safety and how it works in the body.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for this age group are not detailed here, teplizumab may generally cause reactions at the injection site, headache, rash, nausea, and possibly affect blood cells and immune response.

PETITE-T1D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am under 8 years old.
Select...
I have Stage 2 Type 1 Diabetes with certain autoantibodies and blood sugar issues.

PETITE-T1D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sparse pk samples between days 1 and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and sparse pk samples between days 1 and 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), TEAEs leading to withdrawal, and serious adverse events (SAEs)
Secondary outcome measures
Anti-drug antibody (ADA) titers and presence of neutralizing antibodies (Nab)
CD3 receptor occupancy
Serum concentrations of teplizumab

PETITE-T1D Trial Design

1Treatment groups
Experimental Treatment
Group I: teplizumab injectionExperimental Treatment1 Intervention
teplizumab injection, sterile solution for intravenous use
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
teplizumab
2019
Completed Phase 3
~340

Find a Location

Who is running the clinical trial?

Provention Bio, a Sanofi CompanyLead Sponsor
4 Previous Clinical Trials
520 Total Patients Enrolled
Provention Bio, Inc.Lead Sponsor
10 Previous Clinical Trials
1,326 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,819 Total Patients Enrolled

Media Library

Teplizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05757713 — Phase 4
Type 1 Diabetes Research Study Groups: teplizumab injection
Type 1 Diabetes Clinical Trial 2023: Teplizumab Highlights & Side Effects. Trial Name: NCT05757713 — Phase 4
Teplizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05757713 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA accepted teplizumab injection as a safe and viable treatment option?

"Taking into account that teplizumab injection is already an approved treatment, it was assigned a safety score of 3."

Answered by AI

Is there the possibility of my involvement in this experiment?

"To be eligible for this research, patients must have type 1 diabetes and fall between 0 to 7 years of age. As of now, they are looking to enroll approximately 20 participants."

Answered by AI

Is it permissible for individuals past the age of 35 to participate in this clinical research?

"This trial is seeking participants aged 0 to 7. Additionally, there are 224 studies available for minors and 931 trials dedicated to elderly individuals."

Answered by AI

How extensive is the participation in this research endeavor?

"Indeed, according to clinicaltrials.gov, this medical study is currently recruiting patients with a commencement date of May 1st 2023 and the most recent update being on the same day. There is need for up to 20 participants from one single site."

Answered by AI

Are there available slots for participants in this experiment?

"Affirmative, the information on clinicaltrials.gov indicates that this study is presently recruiting individuals for participation. The trial was initially posted on May 1st 2023 and recently updated on the same date. There are a total of 20 participants needed at one site to complete the research."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Site 102
Clinical Site 105
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Anything to advance science to a cure for T1D.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Teplizumab in Pediatric Stage 2 Type 1 Diabetes
2023. "Teplizumab in Pediatric Stage 2 Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05757713.
All > Type 1 Diabetes
~13 spots leftby Oct 2026
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