Teplizumab in Pediatric Stage 2 Type 1 Diabetes (PETITE-T1D)

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ClinicalTrials.gov Identifier: NCT05757713
Recruitment Status : Not yet recruiting
First Posted : March 7, 2023
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
Provention Bio, Inc.

Study Description
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Brief Summary:
The purpose of this study is to assess the safety and PK of teplizumab in participants with Stage 2 type 1 diabetes who are <8 years of age.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Biological: teplizumab Phase 4

Detailed Description:

This is a single-arm, non-randomized, open-label, multicenter study in the U.S. to assess the safety and pharmacokinetics of teplizumab in pediatric participants with Stage 2 type 1 diabetes (T1D) (two T1D-related autoantibodies and dysglycemia) who are 0 to <8 years of age. Anti-drug antibodies/neutralizing antibodies (ADA/NAb) will also be assessed and serologic response to vaccines and exploratory T1D clinical features will be explored.

Approximately 20 participants will be enrolled The regimen consists an intravenous infusion of teplizumab once daily for 14 consecutive days. The study duration for each individual may last up to approximately 26 months

The safety, tolerability, PK, ADA, and T1D clinical feature data will be summarized using descriptive statistics.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, non-randomized, open-label, multi-center study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm, Open-label Study to Assess the Safety and Pharmacokinetics of a 14-day Regimen of Teplizumab in Pediatric Stage 2 Type 1 Diabetes (Participants <8 Years of Age With at Least Two Autoantibodies and Dysglycemia)
Estimated Study Start Date : May 2023
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: teplizumab injection
teplizumab injection, sterile solution for intravenous use
 Biological: teplizumab
CD3-directed humanized monoclonal antibody


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of TEAEs, AESIs, TEAEs leading to withdrawal, SAEs [ Time Frame: 104 Weeks ]
    Safety Endpoint

  2. Serum concentrations of teplizumab [ Time Frame: 104 weeks ]
    Pharmacokinetics endpoint


Secondary Outcome Measures :
  1. Serum concentration of anti-teplizumab antibodies (ADA/NAb) [ Time Frame: 104 weeks ]
    Immunogenicity endpoint

  2. Serum concentration of CD3 receptor occupancy on T cells [ Time Frame: 104 weeks ]
    Pharmacodynamic endpoint


Eligibility Criteria
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Ages Eligible for Study:   0 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant is a male or female 0 to < 8 years of age, inclusive, at Day 1
  2. Participant has Stage 2 T1D (two T1D-related autoantibodies and dysglycemia)

Exclusion Criteria:

  1. Participant has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease
  2. Has an active infection and/or fever
  3. Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
  4. Has any condition that, in the opinion of the Investigator, would interfere with the study conduct or the safety of the participant.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT05757713


Contacts
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Contact: Chief Medical Officer, MD 908-356-0514 eramos@proventionbio.com
Contact: Study Director

Sponsors and Collaborators
Provention Bio, Inc.
Investigators
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Study Director: Provention Bio, Inc., MD Provention Bio, Inc.
More Information
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Responsible Party: Provention Bio, Inc.
ClinicalTrials.gov Identifier: NCT05757713    
Other Study ID Numbers: PRV-031-005
First Posted: March 7, 2023    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Provention Bio, Inc.:
Type 1 Diabetes
Stage 2 T1D
Pediatric T1D
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases