What side effects are associated with this type of intervention?

Teplizumab, a monoclonal antibody targeting CD3 on T cells, has been associated with side effects such as rash, which was the most common clinical adverse event. Other treatments for Type 1 Diabetes, such as insulin therapy, can cause hypoglycemia, weight gain, and injection site reactions. Immunotherapeutic interventions like Teplizumab may also lead to immune modulation-related side effects, including increased risk of infections and potential impacts on beta-cell function.

What prior FDA approvals exist?

Teplizumab is a monoclonal antibody targeting CD3 on T cells, designed to modulate the immune response in Type 1 Diabetes. While specific FDA approvals for similar treatments are not detailed in the provided context, the focus on immune modulation is a key area of research. Other treatments for Type 1 Diabetes generally include insulin therapy and continuous glucose monitoring systems, but immune-modulating therapies like Teplizumab represent a novel approach aimed at altering the disease course by targeting the underlying autoimmune process.

What other types of research exist?

Promising novel alternatives to Teplizumab for Type 1 Diabetes patients include anti-CD20 monoclonal antibodies (e.g., Rituximab), which target B cells, and IL-2 receptor agonists (e.g., low-dose IL-2 therapy) that aim to enhance regulatory T cell function. Additionally, therapies targeting the IL-1 pathway, such as Anakinra (IL-1 receptor antagonist), are being explored for their potential to modulate the immune response in Type 1 Diabetes.

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Monoclonal Antibodies

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

Q: What is the mechanism of action of this treatment?

The most common treatments for Type 1 Diabetes (T1D) primarily focus on insulin replacement to manage blood glucose levels. However, emerging therapies like Teplizumab, a monoclonal antibody targeting CD3 on T cells, aim to modulate the immune response. Teplizumab works by binding to CD3, a component of the T cell receptor, which helps to reduce the autoimmune attack on pancreatic beta cells that produce insulin. This immune modulation can preserve beta-cell function and delay the progression of T1D. For patients, this means potentially fewer insulin injections and better long-term glucose control, which can significantly improve quality of life and reduce complications associated with T1D.

Phase 4

Waitlist Available

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)

Must not have

Has an active infection and/or fever

Timeline

Screening 3 weeks

Treatment Varies

Follow Up sparse pk samples between days 1 and 28

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

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.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I currently have an infection or fever.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ sparse pk samples between days 1 and 28

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), TEAEs leading to withdrawal, and serious adverse events (SAEs)

Secondary study objectives

Anti-drug antibody (ADA) titers and presence of neutralizing antibodies (Nab)

CD3 receptor occupancy

Serum concentrations of teplizumab

Side effects data

From 2023 Phase 3 trial • 328 Patients • NCT03875729

70%

Hypoglycaemia

43%

Headache

42%

Nausea

40%

Rash

34%

Lymphocyte count decreased

31%

Vomiting

24%

Pyrexia

24%

White blood cell count decreased

23%

Lymphopenia

23%

COVID-19

20%

Upper respiratory tract infection

17%

Abdominal pain

15%

Neutrophil count decreased

14%

Diarrhoea

14%

Abdominal pain upper

13%

Alanine aminotransferase increased

13%

Neutropenia

13%

Rash maculo-papular

12%

Leukopenia

10%

Fatigue

Cough

Nasal congestion

Nasopharyngitis

Chills

Aspartate Aminotransferase increased

Oropharyngeal pain

Hypotension

Pruritus

Cytokine release syndrome

Pain in extremity

Tachycardia

Proteinuria

Arthralgia

Anaemia

Decreased appetite

Dizziness

Rhinorrhoea

Rash macular

Dermatitis

Gastroenteritis

Erythema

Suicidal ideation

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Teplizumab

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 1 Diabetes (T1D) primarily focus on insulin replacement to manage blood glucose levels. However, emerging therapies like Teplizumab, a monoclonal antibody targeting CD3 on T cells, aim to modulate the immune response. Teplizumab works by binding to CD3, a component of the T cell receptor, which helps to reduce the autoimmune attack on pancreatic beta cells that produce insulin. This immune modulation can preserve beta-cell function and delay the progression of T1D. For patients, this means potentially fewer insulin injections and better long-term glucose control, which can significantly improve quality of life and reduce complications associated with T1D.

Anti-CD3 monoclonal antibodies for the prevention and treatment of type 1 diabetes: A literature review.Moving towards efficient therapies in type 1 diabetes: to combine or not to combine?